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1. overview Diagnosis mnpprobcatalo c Diagnosis 2 Form name title Diagnosis Diagnosis Displayed order Bo Displayed No eur zt Description Database table mnpprobcatalo Processing save mnpprob catalo2 Cancel Save and back top Fig 55 Input screen to copy a complete form After pressing the Copy Form button you are forwarded to a new page The input screen available here enables you to copy a complete form from one of the created projects and to create it in the current project The view is subdivided into two areas The left hand side contains the selection of the source form whilst data regarding how the form is to be copied have to be input on the right The data do not have to be taken over 1 1 from the source form instead you can e g adapt the title or the descrip tion for the new form by hand Project Is the project from which the form is to be copied Form family Designates the form family in which the form to be copied should be located Form name overview Is the selection of the source form to be copied In the target form this designates the name of the new form on the form overview Form name title This is the name of the new form on the form display Displayed order Designates the sequence or the numbering used within the form family into which the form is copied Description A new description can be specified for the new form or the old one can sim
2. Karo 2 26 Krankenhauseinweisung 3 25 zi Add Cancel Save and back Save top Fig 76 View of the editing page for the group of labels for a popup The sequence of the answer options plus the label text and the DB value saved in the data record can be defined With the aid of NEW LABEL it is possible to add a new label and specify a relevant DB value and conversion factor for unit groups and score calculation Alternatively one or more already existing individual labels can be selected and added via App The DB values which are used must be unique within a group of labels A factor may also be addi tionally specified in the case of normal groups of labels for use in scores When set this is used to calculate the score instead of the database value This is particularly helpful when creating qualific ation tests Individual labels which are reused should only be subsequently changed with particular care as the changes are carried out in all usages Unclear compilations may particularly arise with subsequently changing the DB value In the case of lists the ID is always specified as the last numerical value to identify the various individual labels In addition the number of item usages for all labels are listed on the item and label group editing page On the editing page for the single option label all forms and items are listed where the edited label is used 4 9 Welcome gt Project gt Form family gt
3. 2 kv qi feed s 8 k previous scheduled visit gt lt Pleasechoose gt El p ee quee Te Ft visit ie Please choose gt x po fat vist fee s lt Pleasechoose gt El New visit Visit plan preview Fig 29 Incorrect visits are marked with an exclamation mark In comparison with the previous secuTrial versions a free visit corresponds to the behaviour of a previously flexible visit plan The sequence of the visit plan is now determined only according to the number and no longer according to the chronological sequence of the interval days Note Centre specific visits When using the function Patient in multiple centres you can also specify for visits that they can only be viewed and edited from the creating centre This limitation overrides the role rights to forms within the visits If the visit configuration or the function for patients in multiple centres is deactivated again all previ ously created centre specific visits will once again be accessible according to the role rights Visits max earlier No Label Y Type Time lag days to the date of later Y fio Baseline 01 1 fixed jo xenty gt 20 First treatment NN flexible 7 previous scheduled visit gt gt 50 Second treatment O flexible gt ro k previous scheduled visit gt 7 gt ritem e Unscheduled mw co E unscheduled visit 101 1 unschedu
4. DMDTC Date Time of Collection Timing Variables perm DMDUR Duration Timing Variables DMELTM Planned Elapsed Time from Time Point Ref Timing Variables DMENDTC End Date Time of Observation Timing Variables DMENRF End Relative to Reference Period Timing Variables DMENRTPT End Relative to Reference Time Point Timing Variables DMENTPT End Reference Time Point Timing Variables EPOCH Epoch Timing Variables DMEVLINT Evaluation Interval Timing Variables DMGRPID Group ID Identifier Variables DMLOC Location of Dose Administration Record Qualifier DMMODIFY Modified Name Synonym Qualifier of TRT TERM or DORRES Y Fig 74 Excerpt from the list of SDTM variables according to SDTM classification if DM is saved as the domain for the question 4 8 On saving the item comparison with the specified variables and the domain is also carried out in the case of variables and a corresponding warning message is output if necessary This warning mes sage can be ignored by saving again SDTM variables SDSVarName can also be edited and deleted for projects which have already been set to productive mode Aliases can also be defined for the SDTM annotation in the case of items These are described in the questions layers In the content overview You can see a list of the next lowest layer Rules with the No name type and poss following ac tion in this case Clicking onto a rule opens it NEw RULE c
5. Fig 44 On creation the test must be given a name which is shown in the test overview on the tab All thus marked subforms can therefore be selected as test forms The result field must be a score field The actual test is then configured on the project layer The test is only actually displayed in the Data Capture by saving these data Exactly one test can be created for each project To do this the pre viously created test form and the result score field must be selected The minimum number of points for passing the test must also be specified Optionally the maximum achievable number of points can also be specified in this case the participant is not only shown the overall result passed or failed but also the percentage achieved Lookup tables seculrial 17 08 2010 20 35 CEST Dipl biol Susanne Schneider Welcome gt Project Project Study 1 17 08 2010 20 35 39 CEST Lookup tables Study 1 3 Description Database table Extendable Parent table Created Date Entries Usage Medicine Imnpprobmedics ivl 02 06 2009 13 06 CEST El 7A e Pregnancy Imnpprobpregnant O 02 06 2009 12 40 CEST 2 JP Weeks Imnpprobweek O Pregnancy lt Imnpprobpregnant gt 02 06 2009 12 40 CEST 5 3 P Description Medicine Database table Imnpprobmedics Lookup type E Extendable Simple hierarchical Created 02 06 2009 13 06 CEST Entries Setup DB 3 Displayed order Value Source 1 Pa
6. HorizontalGroup erweiterbare Lookuptabelle lt erweiterbar gt lt Please choose Y Fig 65 Excerpt from the subpage for organizing questions and items The listed items can be moved within the form by selecting another question under Move to Properties In the main area Type The first field is the above mentioned type This is followed by the question text This is op tional because it may also be possible to first input the question text on the item layer This is ma jorly the case if a question only has one item You are then free to decide whether the question text is to appear on the Question or the tem layer Unique question label search However so that each question can be searched a question text must be entered in any case for searching with the ExportSearchTool If available the normal question text input at the top can be simply copied to here On first saving this occurs automatically if you do not specify a separate text The Displayed order defines the sequence in which the questions are presented in the FormBuilder and in the DataCapture The Displayed No has no influence on this you may follow your own num bering system in this case This may also remain empty Query menu comment menu If the display of queries and comments has been configured at the project or form level with always or never it not possible to configure this option here If scalable has been selected then a configurat
7. O display only IP ing reverent save O Double Data Entry HO print Database table mnpproxform4 Displayed order 5 Displayed No Fig 52 Additional checkbox for form processing with DDE configuration DDE processing can also be set retroactively for forms that have already been set to productive mode This cannot be reversed and it is therefore important to carefully consider this action When copying forms DDE can be selected or deselected This can be used as an alternative for resetting forms which have not been set to productive mode Users will receive a warning message when set ting DDE processing ATTENTION Once set and saved this property can not be set back Fig 53 Message when clicking the checkbox for DDE in a form After setting and saving form DDE processing this cannot be reversed Additional processing method randomization If configurable randomization has been set up for a project at the form level you can configure Ran domization with the additional checkbox as the processing method for the individual forms The configurable randomization button created in the form is then no longer displayed as a button but as a notification text In this case the randomization will take place in one step when saving the form data When entering stratification factors for the configurable randomization buttons of such a form only that form in the current visit can be selected as the sources of t
8. user input save Compare or Assign Operator equal value Database table mnpprobpersdata Displayed order 10 Displayed No lI a gt Form name title Pers nliche Daten Compare Value Item Description HTML Compare value from following item Form a a Get values from visit Referenz lt mnpprobp only according to single rules before Item PatlD Birth lt bithda Validation and rules Compare value from following source curent vist gt peta Pat ID Comme IIF Identification Query Cancel Save and back Save if Textfield 10 Birth dd mm yyyy birthdate checked Date DD MM YY 10 ossik 0 Error the value is not correct equal value lt item gt Referenz lt mnpprobpersdata2 gt Birth birthdate current visit rea Fertig a Fig 48 Implementation view of a form in the preview The overview on the form family page contains the Preview button via which a pop up with the form preview for the selected form opens Various form views can be selected in this preview window Preview Print display Implementation Search display Reload Print Close Fig 49 Header and footer of the form preview The header and footer will not be printed Preview The general preview shows how the open form will look like in the DataCapture Print display The print display shows the form view in the DataCapture print display Implementation view The implementation view default documents all s
9. User Manual secuTrial FormBuilder Valid for version 4 7 As of 13 10 2014 interActive Systems Berlin 1 IntTFOdUCION PEUT 4 1 1 Structure OF this manual c titer echte ctun e Hee dO IO ORE Qieoneyath ue ege de bec pa SERRE nd dne a pou 4 Client system requirements dotes roni i n 4 Access prerequisife eee a aaa a aaa a a a aaa a aa a Taaa eiii 4 General User Information E eite EO dido ini 4 The FormBuilder within secuTrialQ essssseenenn mme 5 1 2 Explanation regarding project VersiONiNg ccoonoocccnnnnnoccciccconononnnncnnnnoncnnnnnnnnnn nan ncnnnnnnnancnnnnnncnnnn 5 Version Status rica 5 EditabllitY cocina 5 HEIL 6 Synchronised transfer to productive mode ssssseeeee 6 E ig a aaaaEAaa iaaaaaNaaEia 7 2 1 The FormEngine translator between database and HTML forM ooooooccccnnnnccccccnonanancncncnanancnnnnnna 7 2 2 Page structure of an eCRF in the DataCapture ooooccccncoccccccccooocccnnccnnnnnnnnnnnnnnnnnnncnnnnnnnnnnnnnnnnnnnnns 7 2 3 FOMMISTUCIUTS comcel tii 8 Operationen aaa 10 3 1 Window structure and navigation elements sssssenmm enne 10 3 2 Basic operation fmotes uestre itr R RE UY RON IRERRERN RD are ate ERR EENM 12 Walk through Layers properties and options sssssssssseeeeeemeennn nennen 14 L
10. tionally necessitate the definition of conditions An item may have several rules and a rule may have several conditions Only rules within a project can be taken over on copying the form One further option for subdividing plausibility checks is that according to hard or soft rule conflicts Hard violations mean that an incorrect value has been input this is not taken over into the database under any circumstances or is constantly the subject of complaints that it is incorrect Soft violations are improbable or untypical values e g outside of the standard ranges however these are toler ated after a warning This distinction cannot be portrayed in the DataCapture Rule violations cannot be bypassed except once by deactivating the form check Only the option of querying i e a warn ing is available for identifying soft violations In this procedure a warning message appears whereupon the value has to be saved i e confirmed again and is then taken over Forms with such rule violations are marked in grey soft violation or red hard violation exclamation mark next to the form icon in the DataCapture For the majority of plausibility rules you can define whether a viol ation is to be handled as hard or soft see Fig 79 Actions This includes all rules which trigger an action on occurrence of a specific condition e g the trans mission of a message hiding of questions and items or the freezing of a casenode patient For de
11. 21 KB secuTrial i amp s Berlin 2010 Fig 40 Welcome page of the DataCapture with download area Clicking onto the link opens the browser s download window and the corresponding document can be downloaded from the server onto the participant s local computer This function enables the upload of documents which are available to the DataCapture users for downloading on the welcome page The documents can be released for all participants or in a role related manner in the AdminTool they are not displayed in the DataCapture beforehand 10 seculrial Date 17 08 2010 20 22 CEST Participant Dipl biol Susanne Schneider Print Logout Welcome gt Project Project Study 1 17 08 2010 20 20 06 CEST PROB Registry No 2 Development Project documents Study 1 2 Display name Select a file Durchsuchen Upload The upload can take a period of time depending on filesize and connection Stored project documents 2 No Display name File name Status Size Ho UsrMaud User Manual doc Ok 21KB Delete File text ao gt Regulatory information Regulatory information doc Ok 21 KB Delete File text Cancel Save and back Save top Fig 41 Editing page for project documents in the FormBuilder The status specifies whether the document is actually available on the server Only available documents are available for download in the DataCapture These documents can be uploaded from t
12. CEST Productive 1 2 29 04 2010 11 04 34 CEST Projekt Registry IAS 24 09 2009 13 20 56 CEST Development 0 12 08 2010 14 09 32 CEST EBB Registry lAS2 01 06 2010 10 59 02 CEST Development 0 12 08 2010 19 01 23 CEST Projekt C Registry IMP 22 07 2010 18 44 12 CEST Development 0 17 06 2010 11 45 02 CEST PT2 Registry IMPO 01 07 2010 11 57 06 CEST Development 0 12 08 2010 19 01 37 CEST Projekt_LP Registry LP 16 03 2010 11 34 53 CET Development 4 20 04 2010 16 06 59 CEST P Projekt LP Registry LP 16 03 2010 10 31 45 CET Productive LP3 d 16 03 2010 10 47 06 CET Beispielstudie A Registry PROA 17 11 2009 11 27 47 CET Development 2 23 11 2009 11 47 14 CET Beispielstudie A Registry PROA 09 11 2009 12 01 03 CET Productive 1 0 1 11 11 2009 15 50 31 CET Beispielstudie B Registry PROB 09 11 2009 11 54 44 CET Development 2 01 12 2009 16 19 39 CET Beispielstudie B Registry PROB 09 11 2009 11 54 44 CET Productive 2 0 1 23 11 2009 10 07 12 CET Beispielstudie C amp Registry PROC 08 06 2010 13 43 44 CEST Development 0 08 06 2010 13 47 09 CEST Teilprojekt Part project PROD 23 11 2009 11 57 58 CET Development 0 23 11 2009 12 01 55 CET KFO Registry PROZ 12 08 2010 16 05 56 CEST Development 0 12 08 2010 19 01 09 CEST Test Registry TEST 12 08 2010 17 00 17 CEST Development 0 12 08 2010 19 01 53 CEST Catalog list Fig 8 Welcome
13. Following release the project can no longer be edited until it is actually transferred to productive mode Setting to productive mode is not carried out immediately but only when synchronised trans fer to productive mode next takes place see section Synchronised transfer to productive mode Closed projects can still be released this is no longer possible for inactive projects Undo project release The release of a project to productive mode can be undone if there are more than two hours until the next transfer into productive mode or the next synchronised restart displayed on the release page of the project The undo process is performed on the release page The link on the page overview page will be renamed to Undo release if the project has been released before Both the release and the undo command must be confirmed once After the release has been undone the project can be edited as normal in FormBuilder The undo procedure itself is not recorded Welcome gt Project Undo release Example study Until 1 hour before the transfer into productive mode you can undo the release Last release 03 06 2014 18 41 41 CEST This project is released for versioning Vers abel Reason for release first release of Schneider Susanne Dipl Biol lt susanne gt After release the project cannot be edited any longer An already existing productive version of the project setup will be archived during this process The existi
14. Navigation A Project Basisregister 12 08 2010 17 30 53 CEST ASO Pa form family name Begleitmedikation Manara Type Displayed order 8 Included forms 1 Displayed order shown no Form name overview Form name title Based on table Preview Hidden Delete from databa _ Nextiayer D gt 10 Begleitmedikation 2 Begleitmedikation mnpias begleit Show Copyformfrom Newform _ Buttontine Bt Save and back Save top Fig 5 Subdivision of the FormBuilder window into the various page areas The FormBuilder will be displayed in a normal browser window Nevertheless you should never use the browser back or forward buttons to navigate between the FormBuilder pages Use the navigation links and buttons directly on the FormBuilder pages instead The FormBuilder pages consist of various areas which occur on the majority of individual pages Header Contains certain formal data by analogy with the DataCapture user date and the general naviga tion buttons Locour PRINT and PREVIEW PReview On all saved pages in the hierarchy under the form family this button can be used to open an additional window with a preview of the form without annotations or other views IMPLEMENTATION On all saved pages in the hierarchy under the form family this button can be used to open an additional window with a implementation view with annotations of the form or other vi
15. This addition also takes place when the input domain is not contained in the selection lists lt Please choose gt AGEU Age Units Qualifier Variables ARM Description of Planned Arm Qualifier Variables ARMCD Planned Arm Code Qualifier Variables BRTHDTC Date Time of Birth Qualifier Variables DMDTC Date Time of Collection Timing Variables perm ETHNIC Ethnicity Qualifier Variables RACE Race Qualifier Variables RFENDTC Subject Reference End Date Time Qualifier Variables RFSTDTC Subject Reference Start Date Time Qualifier Variables SEX Sex Qualifier Variables Fig 73 List of SDTM variables for the domain DM Demographic Variables can additionally be selected via the SDTM classification of the variables to do this the check box must be clicked in the CDISC area for the item and the classification must then be selec ted via a further list The list of possible variables is then extended by all variables within this classi fication IV via SDTM classification Events General Observation Class DMACN Action Taken with Study Treatment Record Qualifier DMACNOTH Other Action Taken Record Qualifier DMBODSYS Body System or Organ Class Record Qualifier DMCAT Category Grouping Qualifier DMCONTRT Concomitant or Additional Trtmnt Given Record Qualifier DMDECOD Standardized Treatment Name Synonym Qualifier of TRT DOMAIN Domain Abbreviation Identifier Variables
16. purpose The rest of the main part remains identical for both cases The compare operator and in compare value the format or the type of compare value fixed number NULL etc are specified here The visit field can be used to determine whether the compare value is to be taken from the current the preceding or the first visit After the compare value is localised or described in this manner it can be defined to a value If it has been taken from another field which has a group of labels e g radio button or drop down list the labels e g YES or NO can also be selected here instead of the DB value 5 1 HTML formatting Only pure text can be input in normal form fields in the FormBuilder In this case source material formats cannot be taken over In contrast German umlauts are automatically accepted In certain fields which more frequently demand formatting particularly help texts text can be formatted with HTML tags The fields are marked with HTML behind the field designation How ever knowledge of these tags is required for this The most important of these will be presented in the following More precise instructions can be found in the relevant literature or in the Internet e g under http de selfhtml org Special characters amp Auml a amp auml amp Ouml amp ouml amp Uuml amp uuml fj amp szlig amp lit gt amp gt amp amp amp amp quot Font markup I
17. which will then be replaced by the repe tition number of the group beginning with 1 just like the visit numbering If the group names are displayed the group visits which belong together are indicated with brackets in the overview The maximum number of repetitions gt 1 can be entered for groups If no maximum number is defined the group can be repeated as often as desired For groups with multiple visits the number of visits that should be immediately created when creat ing the group gt 1 can also be entered The time lag between the visits in a group can only be defined to the previous scheduled visit All visits of a group can only be assigned to the same treatment arm Visit groups can be created with one unscheduled visit each If scheduled visits have already been created in a visit group no unscheduled visits can be added to the group For visit groups with un scheduled visits only the name can be configured The maximum number of repetitions is entered directly with the unscheduled visit In the DataCapture visit groups with unscheduled visits can also be created via the option for select ing unscheduled visits In this case only the name of the visit group is additionally displayed above the visit name in the form overview of the patient Visit groups can also be subsequently removed after being set to productive mode The contained visits will remain in both the project template and the patients Visits cannot
18. 2 capital letters followed by 1 hyphen followed by 1 3 numbers C 1 letter followed by arbitrary characters After setting the format can be tested in a small pop up The pseudonym display can be configured in the CustomerAdminTool There is also the option of displaying a further pseudonym the Lab ID laboratory ID Like the Pat ID this is generated using a random function see CustomerAdminTool user manual The display of all pseudonyms can then be defined for the specific roles in the AdminTool Which pseudonym is to be included in the mes sage must then be selected for all messages predefined in the FormBuilder Zus ID Generative consecutively As an alternative configuration for the Add ID you can select automatic generation of consecutive numbering by secuTrial instead of numbering entered by the user You can select either the com plete project or the respective centre as the basis for the numbering If you select the centre as the base of numbering a centre prefix must be defined in the AdminTool If you select the project as the base of numbering a project prefix must be defined accordingly in the AdminTool Because patient pseudonyms must be unique across all projects in a customer area this enables the automatic consecutive numbering to be restricted to the respective project Using a project or centre prefix is optional if using Add IDs without consecutive numbering for each project centre For automatic numbering
19. During the further course of the user manual only the designation project will be used s seculrial Date 17 08 2010 19 55 CEST Participant Dipl biol Susanne Schneider Print Logou Welcome gt Project 150 885915 y DB schema user PROB Last DB modification 17 08 2010 19 55 05 CEST Type Registry Part project Project name Study 1 Version Development Release By Vers label C Vers no 2 Last vers modification 17 08 2010 19 55 02 CEST Setup Export Import Export import project setup Release release Properties Edit configuration Edit visit plan 4 Create qualification test Edit patient letter Resources Edit reports 5 Edit statistics 3 Manage project documents 1 Edit lookup tables 3 y Used catalogs 1 Form families 5 Displayed order form family name Type Hidden Delete from database b Sub Subform gt 10 Base Examination Visit p Medication Visit Delete gt Patient status Casenode b Adverse Event Adverse Events gt Images Image Organize visit families Copy form family from New form family Cancel top Fig 16 Overview page of a project which has already been created Editing is not possible on the overview page Proceed to the Edit configuration page to edit project properties Properties In the main area You cannot edit anything yourself However you have the option of switching to various pages on which you may edit sim
20. For further informations on this type of message refer to product specification Il FormEngine chapter messages Form import Se C ulr a l 17 08 2010 20 50 CEST Dipl biol Susanne Schneider Preview Welcome gt Project gt form family gt Form Project Study 1 17 08 2010 20 49 19 CEST PROB Form family Base Examination isit Conditions Define new Following action Define new Import formats Edit import formats 1 Form name overview Personal Data em e userinput display only Processing Save El print Database table mnpprob persdata Displayed order fio Displayed No Fig 57 Import is defined as an optional form property The number of previously defined formats is displayed on the form page After clicking onto the EDIT IMPORT FORMATS link the following page on which you can edit the avail able import formats or create new import formats is displayed If an import format is defined for a form an additional button is displayed on the form page in the DataCapture Sec ulria Date 17 08 2010 20 54 CEST nt Dipl biol Susanne Schneider Welcome gt Project gt form family gt Form Project Study 1 17 08 2010 20 54 09 CEST ROB Registr Form family Base Examination Import formats Personal Data lt mnpprobpersdata gt Name Patient variable Mass import Parser Mapping entries rise Pi Special import O Listing Parser 5 Delete Standard import patid Pat ID Defau
21. If the option Confirmation of form leave during editing has been activated for the project you can define the message under Form leave confirmation message Diese Seite bittet Sie zu best tigen dass Sie die Seite verlassen m chten Daten die Sie eingegeben haben werden unter Umst nden nicht gespeichert NS Fig 62 Window when trying to leave the form with warning before data loss in the DataCapture In the content overview You can see the list of the questions contained in this form with the No and the type in this case Clicking onto the type of question opens this NEw QUESTION creates a new one Copy copies a ques tion and DELETE deletes an existing one 4 6 Layer Question Creation types copying seculrial 17 08 2010 20 59 CEST Dipl biol Susanne Schneider Preview Welcome gt Project gt form family gt Form gt Question Project Form family Study 1 17 08 2010 20 58 05 CEST Base Examination Form Personal Data Type l amp SStandardGroup Standard vertical Question Unique question label search Displayed order 30 Displayed No Query and comment menu Both C Query C Comment C None cR 1 Description 2 Description HTML Help text HTML P cDISC ODM export annotations Cancel Save and back Save top Fig 63 Editing page for a question Questions are used as layout elements and for grouping items Detail
22. Susanne Schneider Welcome Project Project Study 1 17 08 2010 20 06 52 CEST Edit reports Study 1 5 Copy No Report Status Type Delete from database Cc 1 Completion status Ok Status Print Delete 2 Image overview Ok Image forms Print Delete c 3 Queries Ok Queries details Print Delete C 4 WE Ok Single field Print Delete c 5 Height Ok Single field Print Delete New report No 5 Name Height Type C SQL c Single field C Single field per visit C Status C Queries details C Icon display C Image forms O Show reports of all centres immediately C display all pseudonyms display randomization Style definition of the rows odd rows lt Please choose gt Preview even rows lt Please choose gt v Preview Ordered by Timestamp o Form Personal Data mnpprobpersdata z Item Pat ID Height height dr display unit Style definition of the Please choose gt E Preview column if lt 150 0 then use fontred style Preview Empty column Cancel Save and back Save top Fig 34 View of the report editing page in the FormBuilder The overview of all created reports is shown in the top part with editing of the selected report below Reports enable an overview of the entire data status of projects In the DataCapture they can be called up from the menu bar on the welcome page Each participant only ever sees the data for the patients to which he has acc
23. decision between AE and SAE is made by converting from AE to SAE via rules or according to preselection see below You additionally have the option of defining the following rules by activating the corresponding check boxes A query regarding adverse events should be displayed on the form saving confirmation page This must then be answered by the participant On specification of yes the participant is immediately forwarded to create a new AE The interim page for entering patient entry and examination data should no longer be displayed With this configuration the data is assigned the current date and this data will no longer be displayed in DataCapture It is then no longer possible for AdverseEvents to be created in non chronological order After selecting this option the two options Preset event date with current date and Adverse events can be added in random even non chronological order will no longer be offered The adverse events are set to the current date as default This can be changed manually Adverse events can be created in any sequence including non chronological Configuration of overview layout Various settings which affect the layout of the form overview and in particular the visit plan can be carried out in this section Specify which symbol for form families with just one form is to be used in the form overview Normally the planned visit date calculated according
24. first line of the file contains the layer data description The second line of the file contains the column data description The number of characters in these descriptions may not exceed 24 The catalog data begin as of the first entry in the first column after the description lines The data for the next layers are entered continuously behind the entry in the top layer All further lines belong to the same entry in the top layer as long as this these column s has have no entry The number of catalog layers columns and entries is theoretically unlimited However handling capability in the secuTrial catalog pop up should be guaranteed Formatting in CSV is carried out in line with the description here The standard format is the semi colon as a separator double quotation marks as text delimiters Character coding can be selected on import The length of an individual entry in a column is limited to a maximum of 500 characters
25. gt Cancel Save and back _Save top Fig 46 Example Organize visit families As soon as more than two visit casenode and subform families have been created in a project the forms can be freely organised within these families by clicking the button ORGANIZE FORM FAMILIES Before clicking the button you can choose the form family type you want to organize from a drop down list The forms can then be shifted between the individual families and the sequence of the families and forms can be edited Under Displayed order the sequence of both the form families and the forms can be changed Un der Switch to the form family into which the form is to be shifted can be selected The visit plan is not changed via this organisation Medical data which have already been ascertained are also retained The view in the form overview is restructured accordingly and the icon display may change under certain circumstances as these depict the currently calculated sum status of the contained forms Layer Form family Creation types copying seculrial 17 08 2010 20 36 CEST Dipl biol Susanne Schneider Welcome gt Project gt form family Project Study 1 17 08 2010 20 35 39 CEST form family name Type Vist Displayed order 21 Cancel Save and back Save top Fig 47 Creation of a form family in this case For visit forms Once you have created and edited a project clicking onto NEw
26. matrix a maximum of 10 visits are displayed next to each other Further visits are displayed below with a new list of all visit forms The number of visits which are displayed next to each other for editing can be configured from 1 to 10 via an entry field Visit groups are indicated with a blue bracket above all contained visits In the visit plan matrix all directly hidden forms and visits are marked with a dotted red box In the print and documentation view of the visit plan editing page all treatment arms are also listed separately For reasons of better printing a maximum of 5 visits are displayed next to each other Import configuration For each project import configurations can be created that will apply for all forms A link Edit import configurations exists for this on the project overview page The import configuration of a project forms a new editing area in FormBuilder This area can only be edited by one participant at any gi ven time On the import configuration editing page all created configurations are listed in the upper area of the screen An element can be selected from this list for editing or a new configuration can be created In the lower area of the screen the selected or new configuration can then be edited An import configuration is defined in the same way as for the automatic import edited in Custome rAdminTool As the import configuration for the mass import is used directly in DataCapture there is no
27. n New mapping entry Cancel Save and back Save top Fig 60 The parser and general format data are defined in the centre part of the page The individual mapping from external to internal keys is created in the lower part of the page Definition The variable names within and outside of secuTrial may deviate from each other It is therefore ne cessary to specify the mapping from external to internal names variables here If variables for which no mapping is entered exist on import an attempt is made to find these variables directly in the secuTrial definition column name of the form Import formats without explicit mapping data may therefore also exist see below for limitation Additional variables which are to be ignored on import can be specified There include e g format data decimal characters date formats which are contained in the imported file as general informa tion As these data cannot be interpreted as values they are anticipated errors So that the parti cipant is not unnecessarily irritated as a result these variables can be defined as to be ignored If a mapping entry is created an external variable name and an internal variable name must be spe cified The internal names can be selected from all item columns available in the form with the ex ception of the unit fields of UnitGroups and subform items Variables which are already used in the data record identifier can no longer be selected in
28. never Generally made necessary always J Made dependent on the corresponding form or a specific action scalable The action which necessitates an E signature for comments reviews etc is configured in the pro ject configuration For data input in single forms the E Signature is specified under processing in the form configuration Randomization If you conduct a study in which the volunteers are to be subdivided into two groups according to the random principle the randomization function can be used Here you have the option to select between 2 different randomization variations With Simple randomization the randomisation button is subsequently available to you as a form component This is where the naming of the groups takes place and applies for the entire project The randomisation algorithm is described in Product Description II FormEngine In contrast with Configurable randomization multiple randomizations are possible A configurable randomization button will be subsequently available to you as a form component which can then be individually configured with regard to randomization algorithm randomization groups and randomiz ation stratification The various randomization algorithms are described in Product Description Il For mEngine As an additional option with Configurable randomization blinding can be set up Blinding is the only option which is generally set for each project and is used for all random
29. page overview of existing projects lock icon for closed and red icon for inactive projects 4 2 Layer Catalogs From the welcome page the CATALOG LIST button takes you to the overview of all catalogs ac cessible for this customer Only the current catalogs are initially displayed The archived versions of a generic catalog see be low can be shown using the triangle at the start of the page Archived catalogs are listed in grey They can still be viewed and exported but no longer edited The list lists the catalog with the number of layers the number of elements in the last layer the num ber of forms used and data of release area date participant If a catalog has only been created in complete no tables or no contents due to a problem this is indicated by a red exclamation mark Via the CATALOG button the catalog can be viewed in a separate pop up as from within a form Unused catalogs can be deleted again s seculrial 17 08 2010 19 41 CEST Dipl biol Susanne Schneider Welcome Catalog list 25 2 Catalog name Layers Entries Usage Access last changed changed by Nebendiagnose erworben Catalog e 219 1 all 30 06 2009 09 45 CEST Operation Intervention Catalog 2 286 all 30 06 2008 09 45 CEST Intervention Catalog 2 57 0 all 30 06 2009 09 45 CEST Symptom oder Risikofaktor Catalog 2 27 D al 30 06 2009 09 45 CEST Komplikation Catalog 2 82 0 all 30 06 20
30. participant who has the right to edit one of the visit s forms Medication This function enables the participant to create an excerpt of form data from various forms per visit and to print these out with a fixed header text Prolog and footer text Epilog For example this enables the participant to give the patient the essential results of a visit or to forward these to the general practitioner a seculrial Date 17 08 2010 20 14 CEST Participant Dipl biol Susanne Schneider Welcome gt Project Project Title Prolog HMTL Epilog HTML Study 1 17 08 2010 20 14 19 CEST Patientletter Study 1 visi summary You can put this letter to your patient file Preview show Preview Letterfields Form text before value Item Personal Data Elegie Pat ID Allergies lt mnpprobpersdata gt m allergies Personal Data hei Pat ID Weight lt mnpprobpersdata gt wog lt weight gt lt Please choose gt lt Please choose gt z Add item Cancel Save and back Save Delete text after value Hidden Delete SS Delete Delete top Fig 39 Editing page for the patient letter A general text can be input and values can be selected from the visit forms The title start and end of the letter can be input here as HTML format text The form fields which the patient letter is to contain are selected here The text which is to be dis played before and after the item value i
31. pop up window Print Close Project Systemtest 441 Teil 2 22 03 2013 11 55 16 CET Visit plan preview Day Visit Max repetitions 5 ky Treatment arm TA 1 visit visit visit visit initial 1 2 3 4 5 visit 6 7 8 initial initial initial Start visit visit visit repeated 9 visit 9 repeated 10 visit 10 repeated 11 visit 11 repeated 12 visit 12 repeated 13 visit 13 repeated 14 visit 14 repeated 15 visit 15 repeated 16 visit 18 repeated 17 visit 17 repeated 18 visit Mid TA1 1 c Nyon wun o End of Treatment End of Treatment End of Treatment End of Treatment End of Treatment Treatment arm TA 2 D initial 1 visit 1 initial 2 visit eT 2 intial 3 visit 3 initial 4 visit 4 repeated 5 visit 5 repeated 6 visit B repeated 7 visit Kara 7 repeated 8 visit 8 repeated 9 visit 9 repeated 1D visit 10 repeated 11 visit RM Uae 11 repeated 12 visit 12 repeated 13 visit 13 repeated 14 visit 14 repeated 15 visit MITA 15 repeated 16 visit 16 repeated 17 visit 17 repeated 18 visit Mid TA2 18 repeated 19 visit 19 ranrated 211 visit Fig 28 Visit plan preview with different treatment arms and repetition groups max earliear No Label Y Type Time lag days to the date of later Label from item p fi wist fee sz ew ie Please choose
32. pseudonym display can be configured in the CustomerAdminTool Then there is an option to display an additional pseudonym the Laboratory ID Lab ID Just like the Pat ID it is generated using a randomization function see the manual for the CustomerAdminTool The display for all pseudonyms can then be role specifically defined in the AdminTool You also need to select the pseudonym to be used for all messages defined in the FormBuilder Add ID Specify format A format can be specified for the Add ID The format defines how long an Add ID may be and how it is compiled from capital or small letters and numbers The format of the Add ID is specified via indi vidual characters In this case the characters stand for the following list can also be viewed via the on line help Character Meaning Letters and numbers C 1 arbitrary letter L 1 small letter U 1 capital letter N 1 individual number A 1 letter or a number As before but optional c 0 1 letters l 0 1 small letters u 0 1 capital letters n 0 1 individual numbers a 0 1 letters or numbers Place holder 1 or more arbitrary characters Special characters 1 hyphen 1 point 1 underscore 1 colon and other special characters Examples of formats CCCCCC 6 arbitrary letters LLLLLL 6 small letters LLLNNN 3 small letters followed by 3 numbers CAAAAA 6 letters or numbers no number is permitted at the beginning UNNnnn 1 capital letter followed by 2 5 numbers UU Nnn
33. returned to the previous page 4 5 Layer Form Creation types a seculrial jate 17 08 2010 20 44 CEST Participant Dipl biol Susanne Schneider Preview Welcome gt Project gt form family gt Form Project Study 1 17 08 2010 20 40 36 CEST PROB Registry No 2 Development Form family Base Examination Visit Conditions Define new Following action Define new Import formats Edit import formats 1 Form name overview Personal Data n user input Q display only Processing 9 save D print Database table mnpprob persdata Displayed order fio Displayed No Form name title Pers nliche Daten Description HTML Form designation lt Please choose gt e Get values from visit before amp only according to single rules C everytime the whole Form C whole form but only if the days are equal Validation and rules Markup rule based mandatory fields check of completion I immediate validation C Please correct the marked invalid data Form error message Default Farm confirmation message Default Hide in the DataCapture m Included questions 2 Displayed order shown no Question Type Hidden Delete from database gt fo Pat ID lASStandardGroup gt 20 Pregnancy IASCombinedSelection Copy question from New question Cancel Save and back Save top Fig 51 Form with questions contained therein After clicking onto NEw Form under form family y
34. rows When importing by column the dataset for the main form will be entered in one row The con tents for the repetition groups will then be entered in repeating columns To distinguish between the columns an extended identifier is defined for the import format This extends the subform item column headings which are defined as external variables together with the repetition num ber When importing by rows the dataset is not created from a single row but from the change in the identified patient variables and with visit entry in the file from the visit column A dataset for importing can then consist of 1 n rows of the import file Form imports can be conducted into visit adverse event and casenode forms Imports are not pos sible into image forms In order for the form to be recognised for the import the format identifier must precede the column name of the data i e format column The data for different forms can be imported simultaneously within one file The data will then be sorted according to forms during the file analysis When importing in DataCapture only the import configuration for carrying out the MMI has to be se lected All entries in the project import configuration will then correspond with the respective entries from the individual form configurations for the single form mass import Adverse events Adverse events are critical events which occur outside of the normal visits and have to be handled separate
35. score item When determining the displayed precision of number scores the highest value from all defined score rules will be used for the item Before executing the actual rule condition value adoption or calculation the preconditions are first checked Only if these preconditions are fulfilled will the rules be actually applied With score rules in addition to the now newly definable precondition the previously existing option for entering a min imum number of required values is treated in exactly the same way as a precondition User Manual secuTrial 4 7 FormBuilder g Multiple rules can also be defined for one item In this case all of the rules will be checked in the predefined sequence for the item and executed as applicable If multiple rules are executed the last adopted or calculated value will be retained If according to the preconditions no value can be calcu lated for score rules the score value will be reset to NULL E If multiple score rules have been defined for an item the maximum size of the minimum and maxim um precision of the calculation is calculated for the entire via all of the score rules for that item Creation types After clicking onto NEw RULE or onto an existing condition in the content overview under Rule you are taken to the next lowest conditions layer In this window you can create a new condition or change its properties The condition types are also described in Product Description II F
36. selected Input only possible if Inputs impossible if Form input only possible if and Form inputs impossible if The last two rules have been created specific ally for use as prerequisites as they have no effect whatsoever in their own form In this case not possible and only possible only differ in the handling of forms for which no data have yet been in put because they have not yet been saved or no data have yet been input in the field on which the rule is present Therefore consider which form is appropriate On use of the form status as the prerequisite it is only possible to select forms which belong to the same type i e visit forms casenode forms or adverse event forms When checking the prerequisite only those forms originating from the same row i e the same visit or the same AE follow up examin ation However prerequisites are globally defined and it is not possible to define a different pre requisite for each visit even if the defined form does not occur in a visit The statuses can be freely combined On selection of empty status however all other data are ig nored As long as the form has been saved irrespective of how the prerequisite is regarded as met Otherwise all statuses which are adequate as prerequisites should also be selected Completely filled does not automatically include Partly filled In addition you can define an error message text for the status preconditions with max
37. the form overview At other points e g in the reports the default Visit is used instead You must specify for each visit whether it is fixed flexible free or unscheduled see Product De scription for definition The interval from a specific event in days can or must be specified depending on the visit type In the case of flexible free and unscheduled visits you may choose between the entry date or the previ ous planned visit In the case of fixed visits the interval from any scheduled previously defined visit can additionally be specified For each flexible free or unscheduled visit you may specify the interval which the visit date is to have in the future or in the past In the case of fixed visits the date is already firmly defined In the case of flexible visits the time frame for the calculated visit date is checked in the case of a free vis it the current date is the reference value For each defined unscheduled visit you separately specify the maximum number of times this visit type can be created Unscheduled visits are not taken into account when determining the maximum number of scheduled visits for a patient The VisiT PLAN Preview button can be used to show the defined plan and check it for plausibility Note When using treatment arms alternative treatment arms are displayed separately In visit groups without maximum repetitions the number of displayed repetitions can be set in an entry field in the
38. the type of processing can only be changed as regards the selection and deselection of the print property If you select Save and Print for the processing of a form printing will always be immediately triggered in DataCapture when saving data entries You can still print saved forms without Print processing in DataCapture by using the print button from the form menu above the data entry If the form which has already been set to productive mode is no longer to appear in the DataCap ture the option Hide in the DataCapture can be used After setting the option and saving again the entire form is no longer visible in the form overview in the DataCapture On hiding this form is also no longer included in calculation of the completion or the SDV status of a visit or a casenode In the implementation view hidden forms are shown with a red slashed border The option Hide in the DataCapture is only available for projects which have already been set to productive mode Other wise you may also simply delete the form Copy form LJ seculrial 17 08 2010 20 45 CEST Dipl biol Susanne Schneider Welcome gt Project gt form family Copy form from You are reminded that subforms and references outside the form are only copied if they belong to the same project Source Target Project Study 1 PROB 17 08 2010 20 40 36 CEST Study 1 form family Base Examination z Base Examination Form name r Dagoss2
39. to the project plan is displayed in the form overview above each visit If you do not require this date the display can be hidden here Visit plan first displays only last visit and a link to show the previous visits This may be helpful to increase the clarity of the form overview if a high number of visits can be created in a project Configuration of project specific labels All texts for patient entry and creating visits that are defined on the visit plan editing page for a pro ject can now be separately edited for all of the languages configured in the installation The default value is first shown for all configurable texts indicated via the label Default behind the texts If you have saved changes to the texts the label is transformed into a button with which you can restore the default value Title when entering the Add ID If the additional patient ID has been configured for the pro ject the respective text on the page for creating new patients can be changed here Entry Here the label Entry on the page for creating new patients can be changed Note Example Information on creating a patient Here you can specify a text which is to be used to create a patient The entry date specified there is used as the basis of calculation for a casenode s entire visit plan Label for the overview tab In the DataCapture the visit tab label is displayed above the form overview of the visits and
40. 01 35 CEST Exportlimport project setup Test Setup export Setup import Project name Test Project name AWB Contains 7 visits 12 form families uploaded file proj_DEM20_Dev_20100604 1109_AVVB zip 2 Reports 38 Forms was exported at 2010 06 04 09 09 13 Etc GMT D Statistics 240 Questions by AS 0 documents 418 Items from project AWB D patient letters 420 Rules DB schema DEM20 D tests with application STU1 setup FormBuilder 2 Lookup tables version 3 4 0 3 DB version 3 Download Project C ZIP file indented XML on server sm1 asp interactive systems de as ZIP file compact XML Contains 3 visits 9 form farnilies C Gzip file indented XML 3 Reports 12 Forms Export Setup 1 Statistic 36 Questions D documents 101 Items patient letters 19 Rules O tests D Lookup tables You have to erase the setup of the existing project first in order to import a new setup Erase existing project setup Cancel top Fig 17 View of the import export function in the FormBuilder for project import Export This function is used to export project data in the form of XML formatted data The entire project setup forms and all configurations selected forms or single SQL reports can be exported Clicking onto the Form Families link on the export page takes you to the selection of single forms to be expor ted clicking onto the REPORT link to the selection of the SQL reports to be exported Three different options are available for form
41. 09 09 45 CEST Extra Diagnose Catalog 2 0 6P all 30 06 2009 09 45 CEST Y Gr ppchen A Catalog 4 32 O custormer 19 05 2010 15 08 CEST Hobby Admin Delete Gr ppchen A Catalog 5 31 QO customer 19 05 2010 15 08 CEST Hobby Admin Delete Gr ppchen A Catalog 3 13 O customer11 02 2010 12 CET Hobby Admin Delete Gr ppchen A Catalog 3 13 O customer11 02 2010 12 57 CET Hobby Admin Delete Haupt und Nebendiagnose angeboren Catalog 2 D 17 P all 30 06 2009 09 45 CEST HEN Diagnose Catalog 2 D 0 all 30 06 2009 09 45 CEST katalog test 500 Catalog 3 11 1 customerO1 12 2009 16 28 CET Dipl biol Susanne Schneider gt KA5 Spalteweg_Spaltedazu_EbenedazuKA5_Spalteweg_Sp Catalog 3 13 O custormer 19 05 2010 15 04 CEST Hobby Admin Delete Laendercodes ISO 3155 neu Catalog 2 268 0 customer18 06 2010 08 55 CEST Hobby Admin Delete Laendercodes ISO 3166_20100618 074339 Catalog 1 268 O customer18 06 2010 11 02 CEST Hobby Admin Delete Ma nahme Catalog 2 D 0 all 30 06 2009 09 45 CEST D gt MedDRA Test Catalog 3 13 1 customer11 02 2010 11 44 CET Hobby Admin Michels MedDRA Test Catalog 5 31 O customer11 12 2009 16 06 CET Hobby Admin Delete michels medratest Catalog 5 31 O customer11 12 2009 15 26 CET Hobby Admin Delete Testlmport Catalog 3 13 O customer11 12 2009 11 25 CET Hobby Admin Delete Test jonas ulrikeWjoris Linus AOU Catalog 3 1a customer11 12 2009 12 24 CET Hobby Admin Delete gt Te
42. 2010 20 43 CEST Dipl biol Susanne Schneider Welcome gt Project Copy form family from You are reminded that subforms and references outside the form are only copied if they belong to the same project Source Target Project Study 1 PROB 17 08 2010 20 40 36 CEST Study 1 form family Base Examination Base Examination2 Displayed order 10 fiz Type Visit Visit Cancel Save and back top Fig 50 Copying a form family After pressing the Copy Form FAmiLy FROM button you are forwarded to a new page The input screen available here enables you to copy a complete form family from one of the created projects and to make it available in the current project The view is subdivided into two areas The left hand side contains the selection of the source form family whilst data regarding how the form family is to be copied have to be input on the right The data do not have to be taken over 1 1 from the source form family instead you can e g adapt the title for the new family by hand Project Is the project from which the form family is to be copied A Form family Is the form family to be copied The designation of the form family can be changed as desired J Sequence Designates the sequence for the new form family within the project in which the form family is copied in By clicking onto SAVE AND Back your inputs are accepted and the form family is copied CANCEL dis cards everything and you are
43. 500 charac ters This will be displayed in the DataCapture if the precondition for editing the form is not fulfilled The error message text can be formatted in HTML Please note that the unformatted error message text will already be displayed in red boldfaced letters on a white background Following actions u seculrial 17 08 2010 20 49 CEST rticit Dipl biol Susanne Schneider Welcome gt Project gt form family gt Form Project Study 1 17 08 2010 20 49 19 CEST Form family Adverse Event Form AE Following action AE lt mnpprobae gt internal title Adverse event created Triggering status of the form M empty medical review A The saved forms must have been stored with IV partly filled T data review B at least one of the selected states The selection of complete does not include IV completely filled reviewed A B n partly and vice versa data entry complete Review A revoked Reopen data entry manual freeze with errors rulebased freeze D with warnings Content Title Adverse event recored Message start Dear team an adverse event has occurred and was recorded Meassage end Please check if the patient has to be excluded from the study The study team Contains pseudonyms IV Pat ID 7 Add ID IV Lab ID Dispatched form questions 10 Description Remove Form questions lt Please choose gt x Add Cancel Save and back Save top Fig 56 C
44. CE Clinical Events Interventions General Observation Class CM Concomitant Medications CO Comments Domain D urs Ee D5 Disposition EG ECG Test Results EX Exposure IE Inclusion Exclusion Criteria Not Met LB Laboratory Test Results MB Microbiology Specimen MH Medical History MS Microbiology Susceptibity PC Pharmacokinetic Concentrations PE Physical Examination PP Pharmacokinetic Parameters QS Questionaires SC Subject Characteristics y Fig 68 Excerpt of the list of SDTM classifications and SDTM domains 4 7 The domain can also be edited and deleted for projects which have already been set to productive mode Alias data can be defined as further data for CDISC export Arbitrary data on Context and Name are possible in this case both must always be set The Context may be a maximum of 100 characters in length the Name 1000 characters Aliases can also be edited and deleted for projects which have already been set to productive mode S 3 DM SDTM Demographic Pat ID Comment Birth dd mm yyyy Query birthdate BRTHDTC SDTM birthdate ecked Date This person seems to be too young for this study greater than value current date timespan 3650 days Fig 69 Excerpt of the implementation view of a question and item with SDTM annotation The domain and question alias are displayed behind the question component SDSVarname and item alias behind the column name of the item In t
45. Comment e C O Query zs L Dopa Slow Release nul yes no 3 L Dopa Soluble nul ves no s null Of yes a Uno Answerlebel L Dopa Dual Tem nul yes no 6 L Dopa Others null C yes no PI SE p Unit annotation T Date of initiation of Levodopa I I EC UA Fig 3 Nomenclature and localisation of the various form elements on an eCRF This clearly shows that a content breakdown with a maximum of three layers can be portrayed within secuTrial forms The location of the specified elements in the HTML form is shown in the above fig ure Underlying DB hierarchy Formgroup question Formfield item Formfieldrule rule Formfieldruleparam condition The hierarchy of the form elements is also reflected by a hierarchy of the tables in the database The values entered in the FormBuilder for describing the structure of an eCRF and the applied set of rules are saved in these tables Login Change password A Catalog Catalog list Welcome om Form family A Qustion Condition Fig 4 Schematic depiction of navigation in the FormBuilder The blue sequence shows the hier archy of the element layers the yellow boxes show the editing of these elements Addi tional options on a layer have pink backgrounds the general menu items are grey 3 1 Window structure and navigation elements I if Header e C ulr a l Date 12 08 2010 18 29 CEST Participant Hobby Admin Pr De ut
46. DataCapture Similarly arms can also be subsequently assigned to visits This could result in con flicts in existing patient visits if visits have already been created from contradicting arms Optional treatment arms Due to content related context it can happen that one or more arms of subsequently declared treat ment arms can be skipped To enable the correct display of patient s visit plans with skipped arms in reports see Fehler Referenz nicht gefunden these arms can be flagged as optional in the Form Builder The flagging of treatment arms as optional does not influence the creation of visits but only cor rects the display of icon and status reports Treatment arms Preceding arms Following on ier x Name ptional max Visits Rule Y a arms Arm 1 1 DST Test lt mnpiasOdst gt lt hrb gt 10 Show treatment arm if Arm 1 zi lt Arm 2 Am2 1 DST Test lt mnpiasOdst gt lt hrb gt 20 Show treatment arm if Arm 2 I lt Ami Remove Fig 26 Flagging of treatment arms as optional in FormBuilder Configuration of visits This is where you configure the actual visits You have the option to to create visits in groups which can be repeated together or to set up individual visits To create a new visit group click on the New visit GROUP button You can give visit groups a name which can be optionally displayed as a group heading in DataCap ture The group name can be given a numbering symbol
47. FORM FAMILY takes you to the next lowest form family layer A PRINT button above which a pop up with an exhaustive portrayal of all data input on this page is located can be found on all layers of the FormBuilder After clicking on and opening the print dis play the browser s print dialogue is automatically called up Preview ST Formoulder 34 E3 ET Fanara 34066 TA amp https buildserver ias local apps WebObjects ST34 setup FormBuilder woa 1 wo a6dx7zjT3jtt8 1 BISjpBpw_01A5 234 0 0 7 12 9 seculrial 17 08 2010 20 40 CEST Se eer Cums mnpprobpersdata Welcome gt Project gt form family gt Form gt Question gt Project Study 1 17 08 2010 20 40 36 CEST Project Study 1 17 08 201 form family Base Examination it Form family Base Examination Conditions Form Personal Data Following action Question Pat ID Import formats UF Test f r Produktivstellen Item Birth Pat ID patid Add ID Lab ID german number format decimal sign Rule no case insensitive for variables no case insensitive for option labels yes Allow mass import needs at least one CSV Parser Sequence position m Parser Default Parser CsvParser Assign operator Separator Mapping entries Error message This value is not allow Form name Personal Data Parameter is read from own item overview __ _ Processing
48. Form gt Question gt Item Project Example study 15 10 2013 15 19 47 MESZ Form family Visitenformulare Form Inclusion and Exclusion Question Inclusion criteria Item Men or women after the 18th year with no known indication problems Edit label Text yes Return value fi Conversion factor e ID 3261 Usage 4 Inclusion and Exc eria Men or women after the 18th lt diag_1 terig clusion and teri lo accident within the last lt ein_trauma n criteria No special treatment ein therz criteri Ability to understand ein_under gt clusion and Exclusio clusion and Cancel Save and back top Fig 77 Listing of all usages of the current option label Layer Rule set Overview Large parts of secuTrial s extensive set of rules can be used and parameterised with the Form Builder A set of rules also called plausibility check edit check FormLogic is the sum of all checks to which the DataCapture subjects the incoming data It can be subdivided into Format check Limit values A Plausibility in the stricter sense Actions Format check Refers to the data format i e the type and composition of the values input in a field Example No letters may be input in a date field a year must be four digit These rules are firmly specified by the tools and cannot be modified in the FormBuilder Nor can they be bypassed by switching off the rule check Limit value Maximum
49. M EVI uc 14 4 2 MIEV ISI DrPE T E 15 Importing generic catalogs cited tbe avv b aov ed tore RE NEAR pda Ra Rp RR REN TER AN 15 Editing Generic catalogs voir ida Ea 16 Catalog OxPOMt E MM 17 Modify CAAO gS aere 18 4 3 Layer ProJect scu petendo A T E 19 Properties porta 20 EXPOrUIMPOrt SCT o 22 Release Undo project release cit ANKRE eeN 24 Data FOCO rd tables E 25 Project CONfigUratiON coooocccnnnnncoccccccnnnoncnnncnnnnnnnnnnnnnnnnnnn cnn nan nn nn n nn nan nennen nnn nnns ene AREEN 28 ju Li o I 1 p EPE E T ATE T S N ET 35 Import configuration esses nennen nnne nn rra rra nnns nne n nnns inns 43 Adverse OVEM T 45 plene Er 47 eur 49 zu 51 PROJSCUCOCUINGIS EE 53 Qualification test esssssssssssseseeesseseeenen nennen nennen nn nen ntn nt nnne nensi trennen nnns 54 LOOKUP TADISS em 56 Organize form familieS oooooocnnnnnnccnnnnnnocccccnnonconccnncnnnnnnc cnn nennen nennen nennen nnn 57 4 4 Layer eine Em 57 Creation types copyltig i aani ox hene re dus iode rods egregii nere nube eausa Ead d idu TR 57 i EE 58 ijui EL E 59 Copy Torin Tarrilly fFOI s s aiii Puer picco uenis iii ii 60 4 00 Layer FOM ai ci is 61 A Em 61 COPY TOP c EM 64 Prerequisites and following AactiONS oooonooccccnnnnocccccccnnnonacccn
50. REVOKE CN ELSE ROW COMMENT EXCLUSIVE ROWID CTS EXISTS ROWLABEL DISCREPANCY FILE ROWNUM DOCUMENT FLOAT ROWS EMNP FOR SELECT FS FROM SESSION IMG GRANT SET IS GROUP SHARE LMNP HAVING SIZE LOCK IDENTIFIED SMALLINT MNE IMMEDIATE SQLBUF NEW IN START QACCONTENT INCREMENT SUCCESSFUL QAS INDEX SYNONYM Qs INITIAL SYSDATE QUERY INSERT TABLE RANDOMIZE INTEGER THEN SDV INTERSECT TO SUBDOCUMENT INTO TRIGGER VP Is UID VPES LEVEL UNION LIKE UNIQUE Oracle LOCK UPDATE ACCESS LONG USER ADD MAXEXTENTS VALIDATE ALL MINUS VALUE ALTER MLSLABEL VARCHAR AND MODE VARCHAR2 ANY MODIFY VIEW ARRAYLEN NOAUDIT WHENEVER AS NOCOMPRESS WHERE ASC NOT WITH AUDIT NOTFOUND 5 3 Description of the import table for catalogs Files which can be imported are CSV formats including Excel stored in this format Character formats e g bold linked cells are not permissible The file must correspond to the following format Layer llayer2 j tae3 Layer 1 Column1 Layer 2 Column 1 Layer 2 Column 2 Layer 3 Column 1 Layer 3 Column 2 Value E1 1a Value E2 1a Value E2 2a Value E3 1a Value E3 2a o o y ValueE2 ib Value E2 2b Value E3 1c_ ValueE3 2c ss ValeE3 td j ValeE32d ss cc ValeE3 f X jValueE32f All catalog content is displayed in a two dimensional table structure The hierarchy must be clear individual columns within a layer can remain free as long as the hierarchy remains intact The
51. Select ing the checkbox will display all versions of inactive projects and they can still be completely viewed Inactive projects cannot be edited z The archive projects are initially hidden beneath the productive version The triangle at the start of the line can be used to display or hide these versions again A new study or a new registry can be created in the FormBuilder using the NEW PROJECT button after a corresponding project scheme has been prepared by the secuTrial customer administrator in the CustomerAdminTool and if you have the May create and edit projects right A project which has been closed in the AdminTool or deactivated is provided with a corresponding icon Inactive projects can be viewed in the FormBuilder but no longer edited closed project setups can still be edited in the FormBuilder and new project versions can be released 8 seculrial Date 12 08 2010 19 03 CEST articipant Hobby Admin int Logout Wi Welcome Create and edit projects e There are different project types Development Released Produktiv and Archiv e Only development projects may be edited e For creation of new projects a database schema must be created first 8 Project name Type DB Last DB modification Vers status Vers label Vers no Last vers modification Release Basisregister Registry IASO 12 08 2010 16 17 07 CEST Development 3 12 08 2010 18 49 45 CEST P Basisregister Registry lASO 29 04 2010 11 04 09
52. V file Editing generic catalogs An existing catalog can be edited by selecting it from the catalog list a seculrial 17 08 2010 19 45 CEST Dipl biol Susanne Schneider Welcome gt Catalog list Edit catalog Access al last changed 30 06 2009 09 45 CEST changed by Dipl biol Susanne Schneider Catalog name jExtra Diagnose Layer 1 Extra Diagnosegruppe cat_extradiagnose_1 contains 0 entries 10 Extra Diagnosegruppe descrip Layer 2 Extra Diagnose cat_extradiagnose_2 fcontains 0 entries 10 Extra Diagnose descrip 20 EPCC code epec 30 ICD 10 icd10 40 ICD 10 additional icd1 add 150 8859 15 Export Catalog Y Catalog used in 6 forms Daten lt mnpiasOdaten gt Basisregister ASO Development Daten lt mnpias1daten gt Study 2 IAS1 Development Daten lt mnpproadaten gt Beispielstudie A PROA 1 0 Productive Daten 2 mnpproadatenl Beispielstudie A PROA 1 0 Productive eo Daten lt mnpproadaten gt Beispielstudie A PROA Development Daten 2 mnpproadatenl Beispielstudie A PROA Development Qo Cancel Save and back Save top Fig 12 Editing a saved catalog The forms which are used and the relevant project version are shown beneath the catalog description The form name can be used to call up the corresponding form editing page The catalog description but not the catalog contents can be edited here To change the content the catalog must be reloaded by importing it again The
53. a number format must be entered Please note that if a format is spe cified the number of patients which can be created is automatically limited Zusatzliche Patienten ID Zus ID C nein C nur fir AdminTool C zus tzlich zur Pat ID statt Pat ID Erlaubte Zus IDs alle C Format angeben fortlaufend generieren pro Projekt pro Zentrum Format III Seen Zentrums Prafix benutzen Fig 23 Configuration options for automatically generating the Add ID as a project property Audit Trail Each time a form is saved in the DataCapture a complete copy of the medical data record is always created in the AuditTrail The AuditTrail displayed in the DataCapture can be configured as a history only changes to values are listed or as a complete AuditTrail all saved statuses are listed If display checkbox column names has been activated the column names of items will also be dis played in the AuditTrail This can be helpful if you have multiple similar items in questions which do not have their own item texts Form freezing The prerequisites for manually freezing the forms can be defined here the right to freeze forms is assigned in the AdminTool therefore enabling the work flow for study completion to be defined One or both review statuses A B can be selected as the prerequisite Queries Automatic query answer The automatic query answer can be activated here with yes An open query in the form is then a
54. achieved by entering an empty space to be done for each language If a text has been defined instead of the default in a previous secuTrial version this will continue to be used for all languages In this case different texts can be defined for the individual languages Treatment Arms In this area you can configure the treatment arms This is only possible if the rule Display treatment arm if has been applied to an item in a visit form A new treatment arm can be set up by clicking on the button NEW TREATMENT ARM Treatment arms are initially defined independently from the visits An existing treatment arm rule is then selected as a condition and the visits are assigned to the various arms Each treatment arm rule can only be assigned to just one arm For each treatment arm you can specify the maximum number of visits which can be created in that treatment arm Treatment arms are always alternative sequenced visits Normally a patient can only be assigned to just one treatment arm In order for arms to follow each other in sequence e g to enable changing between different arms it is possible to select a previously defined arm as the predecessor of an arm For each arm all previous and following arms are listed in the FormBuilder The visit arm conditions are checked during the creation of every new visit even if the previous visit has already been created for the same visit plan arm If it shall be possible to leave a visit p
55. an only be extended in the Since 4 7 structure not reduced The DELETE button is then no longer available However deletion may also be impossible due to plausibility checks A corresponding note is then provided In the current version the following new functions have been introduced Configuration of Missing Values MV Import configuration for multi mass import MMI Multilingual project texts Superordinated configuration of queries and comments Undo project release Test area The test area can and should be used to check forms and any rules for consistency before these are set to productive mode Once a project has been set to productive mode nothing further can be de leted from it or e g no incorrect rules can be edited The rules can only be corrected by releasing a revised version Once created form families forms questions and items can no longer be deleted after being set to productive mode Only new form families forms questions and items can be added In case of ne cessity productive items questions or forms can be hidden in the DataCapture The data are re tained but are merely no longer displayed during data capture in the DataCapture Synchronised transfer to productive mode Released projects are jointly transferred to the productive version at the next possible point in time configured on the server At this point in time all secuTrial tools are first stopped and set to st
56. and back Save top Fig 79 Editing a rule Specification of a rule type determines the effect of a rule The name can be used as an error message text Here the rule has been defined as a soft rule with the check box Only as confirmation After clicking onto New RuLe or onto an existing rule in the content overview under item or question you are taken to the editing page for the next lowest layer Rule Furthermore it is possible by clicking the button Copy rule from to copy individual rules for items All rule items can be copied regardless of the rule type as long as the target form permits the rule type For example it is not possible to copy the rule Close adverse event if into a visit form When copying a rule condition an attempt is made to adjust all references to comparison items or comparison values to the target item If this is not successful the corresponding attribute of the con dition will be reset and the user will be notified that the copy is incomplete After copying rules the completeness and correctness of the rule conditions should be checked In complete rules will be marked with a red number sign in the implementation view The various rule types are described precisely in Product Description Il FormEngine Only a few typical rules are briefly presented in this user manual Limit reached The limit value check is one of the rather more simple rules The rule necessitates the input of at leas
57. and minimum values for data These are used exclusively in numerical fields e g number and date fields Limit values may be defined for such fields in the FormBuilder Plausibility in the stricter sense Refers to the check carried out on the logic and the probability of data which are input In this case comparisons can be defined between Various items of a question Various items within a form Anitem and an item in another form in the same project Above all logic checks are rules of the type The Other diseases field may only be answered with YES if YES has also been specified in the Any diseases field above Checking the probability often requires more specialist knowledge e g If Never any medication has been specified in form A Drug X reaction positive cannot be asserted in form B However both types of check follow the same rules which are defined completely via the FormBuilder This type of rules should be extensively specified by the sponsor but may be supplemented or pro posed by the eCRF designer This check may involve extensive work for both the designer and the investigator This also means that the working time required to create the form essentially depends on the number and complexity of the rules The creation of a rule takes approximately the same amount of time as the creation of an item or a question A rule is always created on the layer of an item and thus a database column Certain rules addi
58. andby mode The FormBuilder then versions the released projects Logging in to all tools is impossible throughout the duration of versioning a corresponding notice appears instead of the login page All tools are then restarted in normal mode The previously released development version of the pro ject can then be edited as normal again This synchronised transfer to productive mode ensures that all productive data capture tools always work with the same data model and project version 2 1 The FormEngine translator between database and HTML form secuTrial server secuTrial database Fig 1 Schematic depiction of eCRF generation secuTrial only generates forms eCRF dynamically from the database contents on request Two central functions are therefore required for the presentation of forms 1 A module which generates a rule based HTML page containing the form see below in the centre part from the database contents In secuTrial this module is called FormEngine and is integrated into the DataCapture not visible to the user 2 A module with which the database fields which define the appearance of the forms can be filled and changed This module is the FormBuilder which enables the eCRF design within secuTrial The FormEngine is used to preview the form here 2 2 Page structure of an eCRF in the DataCapture ate 24 08 2010 17 58 CEST Patient PatiD pxe146 nical Investigator Dipl biol Susanne Schneid
59. ange its properties A maximum of 997 items can be created in a savable form There are numerous types of items These are individually discussed in Product Description II For mEngine The types determine which data type is actually captured and how this is displayed in the form The selection is context sensitive i e the types which are offered depend on which type has been specified one layer higher under question in a radio button matrix type e g only the item type horizontal radio button is displayed Individual items can be copied under Copy Item FRow Precisely as in the case of the questions the project the form family the form the question and then the desired item must first be selected to do this As it is assumed that the majority of items are to be copied from the current question this is preselected However items may also be selected from all of the projects saved throughout the en tire installation i e also from other project versions In the case of such a copy only the set of rules which refers to the same form or to a form in the same project can be copied Manually checking the copied set of rules is recommended under all circumstances Properties In the main area Type Here the chosen item type is displayed see section above Depending on the item type there is a limited option to change the item into another related one e g horizontal radiobutton into a vertical radiobutton or Popup 40 tex
60. as now also been implemented for this In the current version this configuration has been shifted to a separate item properties area corres ponding to the CDISC area for questions The Set button takes the selected variable of the specified list over into the input field In secuTrial only the SDTM variables which are sensible for data capture in forms are offered An entire range of variables arises from the meta information which is automatically captured and saved in secuTrial e g patient ID centre or visit date As the SDTM variables are input via a free text field however inputting variables which are not offered is also possible A list of the reserved SDTM variables can be found in the Annex to Product Description II FormEngine Y CDISC ODM export annotations SDSVarName BRTHDTC via SDTM classification BRTHDTC Date Time of Birth Qualifier Variables c Se e ODM Alias Add ontext Name SDTM birthdate Remove Hide in the DataCapture rea Containing rules 5 Fig 72 Editing the CDISC annotations for an item When folded closed the variable and the number of defined aliases are specified as in the case of a question see Fig 67 If a domain has been defined for the question all variables defined for the domain are offered in the selection list In the case of variables with domain prefix the prefix is replaced with the domain code in the selection and also when taking over by means of the Set button
61. at least one repetition even if the repetition group has been configured for display in DataCapture with an initial repetition of 0 in CONFIGURATION you can make general settings for the project settings for region Audit Trail e signature patient ID patient self documentation PSD double data entry DDE centre spe cific project versioning CPV etc Create an additional PATIENT LETTER which reads items out of multiple forms Upload ProJecr Documents which can then be downloaded from the DataCapture welcome page Edit and delete REPORTS or create new ones Edit and delete Statistics or create new ones Create or delete a QUALIFICATION TEST Define and edit Lookup TABLES A fold down list of all catalogs used in this project can be found here The catalog can be selected for editing via the name or the catalog content can be viewed in a separate pop up via the CATALOG button In the content overview you are provided with a list of the form families contained in this project Clicking onto the name of a family opens it clicking onto NEW FORM FAMILY creates a new one and clicking onto DELETE de letes an existing one The ORGANIZE VISIT FAMILIES button enables forms to be shifted between visit form families within a project and changes to the sequence of families and forms Export import setup seculrial 17 08 2010 19 56 CEST Dipl biol Susanne Schneider Welcome gt Project Project Test 13 08 2010 16
62. atting the exported data A ZIP file compact XML Exports the data compressed as a ZIP file without indentation A ZIP file formatted XML Exports the data as formatted XML compressed as a ZIP file with indentation for better legibility Gzip file formatted XML Also exports the data as formatted XML compressed as a Gzip file For import purposes it is normally irrelevant whether the XML data are formatted or not If you wish to read the data in XML format for any reason you should select the formatted variant However compact XML without indentation is up to six times smaller than formatted XML For a simple back up or if you export in order to actually import the project into another project you should select one of the other variants seculrial 22 03 2013 11 38 CET Niels Waller Welcome gt Project Project Biomaterialverwaltungsdatenbank KFO179 05 01 2011 11 42 39 CET Export import project setup Biomaterialverwaltungsdatenbank KFO179 Setup export Setup import SOL Reports gt Export Name Contains Upload end Preview go Proben bersicht 1 column 8 O Tumor RNAlater saline Proben von Mukosa 1 O RNAlater nicht vorhanden None columns und isoliert Download ZIP file indented XML Reports as ZIP file compact XML O Gzip file indented XML without 2 document files Export Setup Fig 18 Selecting the SQL report for export The number of defined columns is given as a brief chara
63. be met Table A must have been specified as the higher table for table B The desired selection options in table B e g gt 12th week must possess the corresponding entry from table A as the higher entry If you have now included these two tables in the form table B only contains the selection options be longing to the current selection in table A For every lookup table it is listed in how many forms and which forms to view click on the expand triangle it is used and in which items You can use this list to directly access the editing page for the respective form or item On release of the project the entries of lookup tables from the development project are transferred together with the entire form setup to the productive project and are versioned Note 4 4 The entries of participants in extendable lookup tables are not taken over into the productive setup on release or included during setup export Organize form families amp seculrial 17 08 2010 20 36 CEST Dipl biol Susanne Schneider Welcome gt Project Organize visit families Displayed order form family Form Move to fio Base Examination fic Personal Data lt mnpprobpersdata gt k Please choose gt fo Diagnosis lt mnpprobcatalo gt k Please choose gt fo Referenz lt mnpprobpersdata2 gt n Medication fo Concomitant medication lt mnpprobpersdata3 gt k Please choose gt zo Therapie lt mnpprobcatalo1 gt k Please choose
64. be subsequently as signed to a group 63 visit D flexible v 1 previous scheduled visit 5 P La End of Treatment v 1 Newvisitin group e 73 visit D flexible v 1 lt previous scheduled visit gt Please choose gt Y b 74 visit D flexible v 1 lt previous scheduled visit gt b New visit group New visit Visit plan preview Fig 27 Creating visit groups A new single visit can be set up by clicking onto the New Visit button A number must be specified for each visit The visits are created in the specified sequence The se quence of the project s visit plan is now only oriented according to the numbering not according to the interval in days A text can be defined for each visit The default value in this case is visit whereby the character is replaced by the relevant visit number starting with 1 You may also calculate the visit number for the label different see online help The default value can also be restored following changes in this case Due to reasons of space this text button is merely called D An individual item whose value is displayed as an additional heading above the visit can be selec ted for each visit Apart from that a separate text in which the automatically generated number can be inserted via a place holder can be specified for each visit see on line help If no text is specified for a visit the text is omitted completely from
65. ble cheating is therefore permitted for the administrator No rights have to be assigned for the test form Welcome texts for the qualification test and the button label can be configured in the AdminTool gt design under DataCapture texts for participants Test form In the FormBuilder the test is created as a multiple choice test in two steps First a test form must be defined This can only be created as a subform and may only contain radio buttons check boxes and at least one score field for the evaluation In this case the form is expressly identified as a Test form It is not saved in the database and does not therefore require any specification on the DB table or DB columns A score field which must be provided with a corresponding calculation rule is required to evaluate the test In evaluating radio button items the conversion factor can be used for score calculation if e g only 1 out of 5 different options is correct Test definition seculrial 17 08 2010 20 34 CEST Dipl biol Susanne Schneider Welcome gt Project Project Study 1 17 08 2010 20 28 51 CEST Qualification test Study 1 Name Qualification test Maximal number of tries E Minimal number of points for success P Maximal number of points Qualification test form Qualification test Resultfield Please answer all questions and then Result lt resulb gt Cancel Save and back Save Delete top
66. can be made in the FormBuilder for all SQL reports interval The export interval can be individually set for each SQL report The interval can be entered in minutes 5 minimum hours or days It is calculated from the start time defined in the scheme File name CSV This is the name of the CSV file into which the report will be exported If no ZIP file name has been defined in the scheme each SQL report is exported and transferred as a single CSV file If a ZIP file name has been entered the SQL reports with the CSV names will be zipped in the ZIP file and only the ZIP file will be transferred The placeholder lt TIMESTAMP gt will be replaced by the generation time Should the CSV file name not be unique for the ZIP file the file name will be automatically extended with a number suffix The file name specification can also include a relative path to a subdirectory of the export dir ectory specified in the CustomerAdminTool scheme The given subdirectory must exist and have to be reachable with the given login credentials login password in the scheme No zip file name must be supplied The SQL report will then be exported as a csv file into the specified subdirectory Export directory scheme file C export Report name 1 teill reportl csv Report name 2 teil2 report2 csv Export report 1 file C export teill reportl csv Export report 2 file C export teil2 report2 csv No 30 Name Pa
67. cnanonnnnnncnnnenncnnnnnnnnnnnnnnnnnnnnnns 65 eue dn a a e Ea a Ea ides a ea an ia Aaaa Eiaa a aN 67 O 70 A O O 71 4 6 EIE MM 74 Creation types COPYING acsi eee aaie da 74 Organize QUESTIONS sresrerosarsiry a A E ieee EEEE E 75 Propere S a C Em 76 Alot ayer MMM aceite a tru D Het tod n 78 Creation types Copyliig dece RD tre tere eo ote ehe eee cad reete eset e PP DDR dd 79 Properties TAN 79 4 8 bayetr Group t labels uote t Eat e eO tite Rd e eth ues 82 eMe Pe 82 Create new label edit labell cccccccccccceeeeeeeeeeeeeeeeeeeceneaeeeeeeeeeeeeeeeeeeteeeeeeeeeaaeeeeeeeees 83 AI ayer Rule Set acini a e co peo b HD a ete Op n ree e tadietaise s eR E dees 84 BUDE E G 84 Effects of rules ace htec oreste a ost teste due asa 86 Greatlon types acea odi e a a UR EEUU FEARS TAPER SRI ERA RSRRRIBEFTER ISeutA 87 Properties adi ei ce cete 88 4 10 Layer CONO i Ere oe rem eiae rtu e ertet nete dde rms 89 OVEMVI ME PM ects 89 Creatlonm types arer e dtes ido NRI ELLE 93 Properties e Lr Pul cA An Lei c EN 94 O s ener humi DM ULM eic MIR i Unt M EU deese eat asse t E REN 96 5 1 HTML Tormatting iiie rri tee eer A TAS O 96 52 Reserved Words sse a a a oca 97 5 3 Description of the import table for CatalOgS oooooniniccncconccccn
68. cnnnnccccccccnnnnnnnnnnononnnnnnnnnnnnnnnnnninnnannns 98 1 1 Structure of this manual The user manual follows the concept from the general to the specific The first chapters explain the basics including a few notes on the study setup The second half deals in detail with software opera tion on the basis of examples A more detailed explanation of the individual question and item components plus report and statist ics types can be found in Product Description Il FormEngine This can be used as a reference when creating a study Client system requirements A PC with Internet connection or intranet connection on development in the company network serves as a client The platform is basically irrelevant The prerequisite is a browser e g Internet Explorer 6 or later A Mozilla Firefox 2 0 or later Javascript activated MetaRefresh permitted no pop up suppression Access prerequisite Further prerequisites Known address customer specific URL of the FormBuilder A participant account user name and password and the right to edit the setup for a project Access right administration is carried out in the secuTrial AdminTool You require a participant or role right for editing projects in order to log on Only those projects for which you have a correspond ing right can be viewed and edited General User Information FormBuilder is accessed via the Internet Slow unstable or unsecured Internet connecti
69. create patients if they don t exist in the database In that case column headers for the patient s entry date and centre must be specified here and the imported file must contain the corresponding data Centre identifier For identifying the centre in which the patient has been or is to be created the centre has to be specified in the import file The appropriate column headers are needed and must be defined here Centres will not be created during the import and must already exist Visit identifier for imports into visit forms A column heading can be entered for each visit property It can also be configured to automatically create visits if they don t exist in the data base In that case column headers for the visit date must be specified here and the imported file must contain the corresponding data During the import the visits will be identified with all of the entered columns or newly created if allowed This also makes it possible to import an unscheduled visit with the visit name and number in a certain repetition Identifiers for adverse events for imports into adverse event forms The configuration to al low the creation of visits also allows the creation of adverse events and follow ups To identify or create a follow up and adverse event the number and or event dates has to be supplied Repetition groups To import in repetition groups the repeated subform data can be specified in the CSV file by columns or
70. ct Study 1 17 08 2010 20 58 05 CEST Form family Base Examination seculrial Centre Centre B Germany Form Personal Data Back Help Logout B gt Welcome gt Patientick371 Personal Data Queries Comments Audit Trail Import Print Pers nliche Daten Document No 24 3 Please correct the marked invalid data Please check marked entries before saving IIF Identification mss Comment This person seems to be too young for this study Birth i2 o2 2009 dd mm yyyy Birth place xfb Input required for the sake of completeness Allergies C dog C cat C house dust Input required for the sake of completeness Sex C female C male Blood sample taken r Input required for the sake of completeness Weight JL jJ Height foo p BMI h score Q Pregnancy Comment Input required for the sake of completeness Week k Please choose gt Last saved by Hobby Admin Rea Daten importiert at 11 11 2009 13 02 31 CET Project version 11 11 2009 12 44 45 CET Cancel Calculate scores Save Save close entry M Check data Date 17 08 2010 CEST Clinical Investigator Dipl biol Susanne Schneider Project Study 1 17 08 2010 20 58 05 CEST Centre Centre B Country Germany Pat ID ick371 1 visit 03 02 2010 CET Form family Base Examination Form Personal Data Document No 24 3 Fig 61 Display of rule violations and completion check with defined error messages in the DataCapture
71. cterisation of the reports Once you have selected the appropriate export format click onto the ExPorT Setup button to start export You are now requested to specify a location for saving the exported file During export the general export information the version status the version label and the database identifier for the customer area of the exported project are exported and accordingly displayed below the project information during import Both closed and inactive projects can be exported Import If you wish to import a complete project a non productive version of a project must be available In dividual forms or SQLreports can be imported into projects which are already productive as these do not delete existing contents but are merely added The error status of the report is reset when importing During the import it is not checked whether all of the tables used within the import project are actually present If necessary this can be manually corrected after the report status check For import purposes first determine the file to be imported This must be available in one of the formats available for export Once you have found the file click onto UPLOAD AND PREVIEW Here you have the option of giving the project a name which differs from that of the imported project You are now provided with a brief overview of the project which you wish to import To import an entire project all data for the existing project must first be
72. d rule or warnings soft rule are triggered by rules After completing a form the participant is shown a navigation selection on the confirmation page with which he can directly continue to edit the next form if there is a further form in the visit A warning message before form exit e g by closing the browser or using the browser naviga tion is displayed to the participant An own message can be integrated in the pop up which can be configured in secuTrial per form The confirmation is only displayed if the participant has the editing or modify right for the form and the form is at least partly with an non closed query after DEC editable Because the implementation of the feature is based on a JavaScript function the display of the warn ing is browser dependent There are known limitations with these browsers 1 Firefox since version 4 Only browser defined text is displayed in the confirmation pop up The text configured per form in secuTrial is ignored 2 Opera This browser does not support the necessary confirmation function at all As a minimal replace ment the secuTrial defined warning is displayed as a simple alert pop up before form leave This alert has to be confirmed but the action cannot be cancelled Configuration of adverse events If an Adverse events type form family has been created a further configuration option for adverse events appears in the visit plan Here you have to decide whether the
73. database tables and columns plus the number of entries per layer are displayed behind the catalog description for the individual layers and information per layer Catalog export Select a character code on the catalog editing page and click onto the ExPoRT CATALOG button Now select a location where the catalog is to be stored For export purposes the catalog is again written into the csv format in which it was imported For download purposes the csv file is compressed as a zip file Both the zip file and the decompressed csv file can be imported into secuTrial again When exporting catalogs entries with semicolons or quotation marks will always be enclosed in quo tation marks Quotation marks within this will be masked by doubling For exports next to the char acter set selection there is also the option Always add delimiter If this option is selected all entries will always be enclosed in quotation marks seculrial 22 03 2013 11 34 CET N Waller Welcome gt Catalogue list Edit catalogue Access customer last changed 01 03 2011 12 35 CET changed by DDE 1 Catalogue name Massnahme Layer 1 MaBnamegruppe cat_massnahme3_1 contains 1 entry 10 MaBnahmeguppe manahmeguppe Layer 2 Mafname cat_massnahme3_2 contains 15 entries 10 MaBname maname 20 EPCC code epcccode 30 icD 10 icto 40 ICD 10 additional ied Oadditional Iso 8859 15 C add delimiter always Y E
74. deleted To do this click onto the ERASE ExisriNG PROJECT SETUP button The button with which import is actually carried out is now also activated Press this to import the data Data can also be imported into a closed project However this option is no longer available for inact ive projects Note Catalogs are not included when exporting the setup of a project or form If you want to reimport a project setup which uses a catalog you must first make sure that the corresponding catalog already exists in the secuTrial installation On import you are then requested to assign the appropriate catalogs from the existing installation to the imported setup During import additional information of the exported project e g the version status the version label and the database identifier for the customer area will be displayed below the project information if it was included in the export Please note that no references from imported forms to non imported forms are accepted as these would lead to inconsistencies Once individual forms have been imported you must therefore check the consistency of the configuration and rules yourself Release Undo project release Release a seculrial 17 08 2010 19 58 CEST Dipl biol Susanne Schneider Welcome gt Project Project Project LP1 release You want to release the project To do that please enter a unique version label Wers label Reason for release Releasing this pr
75. e gt v Uberschrift Please choose v Layer 2 Hersteller lt Please choose gt v Name lt Please choose gt v Layer 3 Artikel lt Please choose gt v Modell Bezeichnung lt Please choose gt v Artikelnummer lt Please choose gt v Preis Please choose gt v Cancel Save and back top Fig 14 Assignment of layers on modifying a catalog The relevant modified version is displayed in the catalog list and can be viewed or exported at any time A preview of the catalog can be called up using the CATALOG button next to the designation Note Catalogs are not included when exporting the setup of a project or form If you want to reimport a project setup which uses a catalog you must first make sure that the corresponding catalog already exists in the secuTrial installation 4 3 Layer Project a seculrial e 17 08 2010 19 53 CEST art it Dipl biol Susanne Schneider Welcome gt Project DB schema user UM Type Registry Part project Project name Cancel Save and back Save top Fig 15 Creation of a new project One important decision is first to define whether the project is to be created as a registry entry of new patients or as a part project take over of patients from registries Subsequently changing the type is not possible Several registries or part projects can be edited in parallel in one secuTrial in stallation A customer s first project is automatically a registry
76. e latter case the error message is displayed as a tool tip or after clicking on the asterisk in a small pop up in the DataCapture n addition to the error messages which you have explicitly defined the Check of completion option also contains the specification of whether a value which is required for the form s completion is still missing In this case the check takes into consideration all rules which you have defined including whether a value is not required under certain circumstances The message is displayed in brown colour of status messages instead of red colour of error messages lettering above the items The check is carried out as a confirmation error the warnings can therefore be circumvented by saving again However no additional warning solely for this is written into the form status n the case of the Immediate validation option the form is checked for any rule violations as soon as it is opened and is marked accordingly The check is repeated as soon as you carry out an action on the form set query comment calculate score select catalog field The error message which is to be displayed to you after determining the rule violation above the form directly beneath the form title is defined under Form error message or Form confirmation message Date 17 08 2010 20 58 CEST Patient Pat ID ick371 a Clinical Investigator Dipl biol Susanne Schneider 1 visit 03 02 2010 CET Proje
77. e main part 10 seculrial 17 08 2010 21 17 CEST Dipl biol Susanne Schneider Preview Welcome gt Project gt form family gt Form gt Question gt Item gt Rule Project Study 1 17 08 2010 21 16 44 CEST Form family Base Examination Form Personal Data Question Patient description 1 Item Birth Type Input required if y O only as confirmation Rule name Sequence position 30 Cancel Save and back Save top Fig 80 Editing page for a new created rule Type of rule offers the selection of the briefly explained rule types For the rules Input only possible if Input impossible if Input required if Input required Limit reached if Limit value range if whether the error message is to be used only as confirmation can be configured To do this the check box ONLY AS CONFIRMATION must be activated In this way the participant can still save the forms by clicking the Save button again in the DataCapture after an error message has been dis played once The form then has the status with warning Name of the rule is an optional internal name which is used as an error message if nothing is spe cified under Condition This can be used to facilitate work when checking many conditions of the same type A short description of what the rule does is appropriate This can also be carried out by entering the same here as later under condition as an e
78. e page you are working on whenever you stop working for any period of time When you click on save the data you have entered will be checked If there is a problem an error message will be displayed in red usually at the top of the page If the saving process was success ful a blue notification message will be displayed next to the Save button or you will return to the pre vious page depending on whether you clicked the Save button or the SAVE AND BACK button Many areas in the FormBuilder have an online help facility which can be accessed via the small circled question mark Click on the icon and a small pop up window with the respective help text will open The FormBuilder within secuTrial The FormBuilder is able to generate a data model and the underlying database in parallel with the creation of the form setup Both the initial creation of a project and subsequent changes are there fore possible without installing a new version of the tool The FormBuilder is therefore the most important tool for creating projects Due to the complexity of the task the structure of the FormBuilder is not entirely self explanatory This user manual and Product Description Il FormEngine are intended to help you to operate the tool 1 2 Explanation regarding project versioning Important Version status Within the FormBuilder there are four possible project version statuses 1 Development version in processing Development 2 Relea
79. e project the corresponding file number is then listed for each form Note In this pop up window you can also select whether the HTML tags which can be entered for various labels and help texts within the CRFs should be included in the data record table If this option is not selected only the unformatted text will be included We recommend using the OpenOffice calculator Saving once with OpenOffice can also help to en sure that the data record table will open in MS Excel The generated data record table can then be downloaded via a link in this pop up window Configuration The first table sheet lists the direct project properties as they can be edited on the configuration page Information on the patient entry form and messages from the bundled message dispatch are also listed here Form Overview This table sheet contains a list of the form families ordered by family type The various types are symbolised with different colours Blue is for visit forms Pink is for adverse events forms Purple is for casenode forms Green is for image forms Yellow is for test sub forms Sub forms are not additionally described Instead the used sub form tables are listed with the tables of the main form as the individual sub form displays are integrated into the documentation of the re spective main form Only sub forms for the qualification test are additionally listed Under visit forms the form assignment to the i
80. e to remove an item from a radio button matrix into e g a StandardGroup But it is not possible to move radio button items in another radio button matrix The database structure is not changed by moving items within the form This reorganization is there fore also possible in forms which have already been set to productive mode Organize questions Displayed order Question Item Move to fio StandardGroup fio StandardGroup Horizontaler Radiobutton lt hrb gt lt Please choose gt Nj m StandardGroup Verticaler Radiobutton mit lt vrb gt Please choose b2 0 StandardGroup Popup pop lt Please choose gt Y Bm StandardGroup Checkbox cb lt Please choose gt Y 50 StandardGroup Datumsfeld DMY lt dmy gt Please choose gt Y p StandardGroup Zeitfeld MS gepr ft ms Please choose gt Y po StandardGroup Number 2 0 zwei Please choose v gp StandardGroup Number 9 2 neun lt Please choose v o StandardGroup Text 15 lt text15 gt Please choose v foo StandardGroup Textfeld 9 40 lt textarea gt lt Please choose gt Y mo StandardGroup Score lt score gt lt Please choose gt Y o StandardGroup Dateintervall ymd lt diymd gt Please choose v 130 StandardGroup Layoutdummy null Please choose fm AlternateStandardGroup o Headline Ho HorizontalGroup ho HorizontalGroup Zeitintervall lt zeitintervall gt lt Please choose Y a
81. ed question texts and additional descriptions can be created on this layer An ASStandardGroup which permits the majority of item types is created in the figure For moving items between the different questions within a form click on Organize QUESTIONS see below By clicking onto NEw QUESTION or an existing question under Form you are taken to the next lowest layer Question In this window you can define a new question or change its properties There are numerous types of questions Please refer to Product Description II FormEngine for the type definitions The type determines how a question is composed i e which elements it can contain and how these are arranged The most frequently used type is the lASStandardGroup with which various combinations of different items can be created Note Note To facilitate the creation of forms which always have similarly structured questions it is possible to copy individual questions by clicking Copy QUESTION FROM Precisely as in the case of the forms the project the form family the form and then the desired question must first be selected to do this As it is assumed that the majority of questions are to be copied from the current form this is preselected However questions may also be selected from all of the projects saved throughout the entire installation i e also from other project versions In the case of such a copy only the set of rules which refers to the same form or
82. edication lt mnpprobpersdata3 gt r O O 0 Therapie lt mnpprobcatalo1 gt r Dn r r Cancel Saveandback _ Save top Fig 25 Visit plan editing page General properties are defined in the upper part the individual visits are specified in the lower part Patients should usually be examined at regular intervals These examinations intervals are determ ined in days in the visit plan A distinction is made between the visit plan as a template for the pro Note ject and the patient visit plan based on this which describes the number and precise points in time of the visits for an individual patient The patient visit plan results in the horizontal axis of the form overview in the DataCapture whilst the visit form families form the vertical axis General visit plan configuration The initial number refers to the number of visits displayed in the DataCapture on creation of a patient in this project The number which is input here must not be greater than the number of defined visits A change in this value is not respected for patients already existing in this project The maximum number of visits for each patients can also be defined here If the number of existing visits has reached this value it is no longer possible to create new visits for this patient You additionally have the option of defining the following rules by activating the corresponding check boxes Further visits can only be created after completing all for
83. elected the data from all of the centres is immediately displayed Note Display all pseudonyms By default for each report only the Pat ID is displayed as the identi fier If this option is selected the Add ID and Lab ID will also be displayed depending on the project configuration Display randomization In projects with simple or configurable randomization with this option you can select whether the randomization group or randomization number with blinding is also displayed with the pseudonym There are also various sorting settings for reports Alphabetical Alphabetical sorting of the report by pseudonym Timestamp Sorts the report according to the save date of the patient the creation timestamp for entering a new patient A Patient entry date Sorts the reports according to the entry date of the patient which was entered when the patient was created To copy a report click on the copy link Configuration of reports in projects with CPV In projects with centre specific project versioning it is no longer possible to delete reports Instead the reports can be hidden just as with visits or forms They will then be disregarded in centres where the version with the hidden report is being used If centre specific project versioning is deactivated for the entire project all hidden reports will once again become visible They can then be deleted In projects with CPV changing the report type is only pe
84. er the visits This enables the condi tion to be formed If the patient s blood pressure has fallen by more than 10 in comparison with the previous visit a warning should appear As a condition for the rule Confirm input if in the Blood pressure field this would appear as follows Sequence position 10 Error message Please confirm that the patient has lost more than 10 kg weight during the last visit Parameter is read from own item C this item Compare or Assign Operator difference from value real greater than y Compare Value Item z Compare value from following item Form Personal Data lt mnpprobpersdata gt X Item Patient description 1 Weight weigh Compare value from following 50 pa a previous visit a ignore in first visit Difference compare value 10 Compare number Fig 81 Definition of a condition for checking for a value difference This enables the development of an item to be tested On creation of such a condition consideration must also be given to the fact that the difference may be negative If the blood pressure has therefore increased rather than fallen the difference would be negative The compare operator would then accordingly be Difference less than 10 Format check for alphanumerical text fields In the case of simple free text fields as an item however it may be sensible to check the format of the input text A corresponding rule conditi
85. er visit 02 01 2000 CET roject Study 1 24 08 2010 17 57 28 CEST Form family Base Examination 1 secu ria entre Centre B Germany For Personal Data Back Help Logout gt Welcome gt Patient pxe146 gt Personal Data Import Personal Data Birth dd mm yyyy Comment Birth place Allergies C dog C cat C house dust Sex not applicable C female C male Weight Height i Pregnancy Comment 2 lt Please choose gt z Week lt Please choose gt lIF Identification Blood sample taken Weight Height BMI Comment ri J J gt Score Cancel Calculate scores Save Save close entry M Check data Date 24 05 2010 CEST Clinical Investigator Dipl biol Susanne Schneider Project Study 1 24 08 2010 17 57 29 CEST Centre Centre B Country Germany 3 Pat ID pxe146 1 visit 02 01 2000 CET Form family Base Examination Form Personal Data Fig 2 Page structure of an eCRF in the DataCapture The secuTrial eCRF pages always have the same structure consisting of the header 1 main part 2 and footer 3 Formal data on the participant patient and project plus menu buttons for general navigation are displayed in the header The footer contains the buttons for saving or cancelling the form plus the short version of the formal data for printouts The main part encompasses the form fields in which the data are recorded The FormBuilder defines the structure of the centre part with its fields whilst it has no influe
86. ess rights There are various types of report which can be created and edited from the reports page in the FormBuilder For details on the various report types please refer to Product Description II FormEn gine For each report the report overview list contains a link for printing out the relevant report Print Or you can print all reports out via the menu button in the page header Reports which refer to hidden forms questions or items are handled specifically Single field reports regarding hidden items are regarded as incorrectly defined and are therefore not displayed in the DataCapture The single field per visit reports are filtered accordingly Query reports display queries regarding hidden items with a dot dash border In the single field report you may specify whether the unit is to be depicted for selected form items of the ASNumberField all number fields or IASScoreField score fields types For the Excel download of the report in the DataCapture it is possibly to specify here a file name for the download The place holder lt TIMESTAMP gt can be used to include a time stamp in the file name If a name is given it will be used instead of the former general file name A short online help explains this feature Example Note Automatic report FTP transfer If an automatic periodical transfer of SQL reports to an external server was configured for the pro ject in the CustomerAdminTool additional configurations
87. esulting freezing ends after twenty minutes timeout unless it is cancelled beforehand by exiting the area as normal or by logging out from the FormBuilder Certain fields e g the help texts can be formatted with HTML control characters tags this is mentioned in the explanation for the individual fields Some of the possible HTML tags are described in the Annex under HTML formatting In the FormBuilder these fields are marked HTML Logout seculrial web based data capture in clinical trials FormBuilder iAS You have successful logged out To login Fig 7 Information page following logout You must log out each time following use and on exiting the workstation LOGOUT in the header so that nobody can use your participant account without authorisation After logging out an information page is displayed This contains a link which takes you to the login page again In this chapter the creation of a new form with all details is described on the basis of examples This procedure is essentially based on the hierarchy presented above which is also followed by the FormBuilder navigation 4 1 Layer Welcome On the welcome page of the FormBuilder you will first see an overview of the existing active projects including all versions the release date the version label and the version number for which you have the editing rights In the title row there is a checkbox for displaying all other inactive projects
88. ews PRINT Print display to document the current working area A Locour Cancel editing and exit the FormBuilder Navigation line Shows the hierarchy path i e the layers above the current area with the option of clicking on each one in order to return to this layer without saving Path Specifies the names of all upper elements in the form hierarchy e g the form family or the rule cur rently being edited Main area Main part of the window in which data is entered in the various fields Sometimes with navigation elements which then offer extensions to the individual properties Fields with red asterisks must be filled in others are optional Option area Not contained in Fig 5 These have pink backgrounds and lead to further property pages within the current layer also see Fig 4 For example project option areas include the configuration of statist ics and reports Next layer In the same manner in which the contents of the upper layers are displayed the elements contained in the next lower layer are shown here You can select an entry for editing by clicking on the listed element The option of deleting an existing entry from this layer DELETE and creating a new one NEW also usually exists An entry marked with a contains elements from the next but one layer These can be shown and hidden in the DataCapture by clicking onto the or symbol Folding up or down can be carried out too usi
89. fined point in time and interval The point in time and interval are set in the Ad minTool whereas the message content is set in the FormBuilder In this case identical message types are summarised If e g 10 queries are submitted when monitoring a single patient these are summarised to form one message For empty visit messages you can additionally configure the time period for the messages To do this enter the start and end time of the message and the interval in days with regard to the planned visit date This makes possible to generate warnings for overdue visits as well as reminders for up coming visits For further informations on this type of message refer to product specification Il FormEngine chapter messages Visit plan a seculrial Date 17 08 2010 20 01 CEST Participant Dipl biol Susanne Schneider Print Logout Project Study 1 17 08 2010 20 01 50 CEST PROB Registry No 2 Development Visit plan Study 1 4 Visit plan B il Initial maximal count of visits r Creation of new visit depends on completion status of all forms iv Planed flexible free visits can be added in random even unchronological order iv Unscheduled visits are allowed to be added in random even unchronological order il Number of days the entry day is allowed to be earlier later than the current date n Preset entry date with current date Handling of forms Auto open of first form after the insertion of a new v
90. ges are checked for plausibility before saving i e to determine whether gaps or overlapping ranges are present This check can also be carried out in advance via the SORT AND CHECK button However questionable value ranges marked with a question mark can still be saved following a warning notice Fig 37 amp seculrial 17 08 2010 20 09 CEST Dipl biol Susanne Schneider Welcome gt Project Project Study 1 17 08 2010 20 06 52 CEST Statistics Study 1 4 Recruitment statistics gt 1 Patients over Time Remove gt p Patients according Centres Remove gt B Patients according Visits Remove New recruitment statistic of type Patients over time z Add Data statistics Y 2 Tite weight over time l i Remove Category Daa a Label x axis E Label y axis Chart type bar chat Visit lt Visit plan gt earliest visit with stored form se Item Personal Data mnpprobpersdata Pat ID Weight lt weight gt y Value ranges Possibly incomplete value ranges xpa k ao mee x gt 5 f 000 xf lt oo Remove X J gt 45 00 x Remove New value range Sort and check Generation per project 2 New data statistic of type Numeric items one visit f Add Cancel Save and back Save top Fig 37 Configuration of numerical data statistics with warning notice regarding the value ranges Attention A chart type must also be selec
91. gn Operator greater than value Compare Value current date timespan z Added timespan 3650 days Cancel Save and back Save top Fig 84 Editing a condition This is the lowest layer of the form hierarchy The error message text which is displayed to the user on occurrence of the condition is marked In the main part Sequence position is only relevant for the compilation of scores Error message is the field for the plain text error message which is output in the event of an error in the DataCapture The field is a mandatory field if the rule requires an error message and the for mulation of the error message should firstly refer clearly to the error and secondly be easily under standable for IT laymen It is also sensible to coordinate the error message with the sponsor The number of characters available for error message texts in item rules is 1000 characters Special characters for example umlauts are coded with multiple characters HTML format Parameter is read from determines whether the crucial criterion is located in the own field i e the item for which the rule is currently being created If not the localisation of the parameter value must be specified here as described above in the ex ample e g Start of the disease in form B Disease data After selecting From the following ques tion two further drop down lists in which the form and the item can be selected are loaded for this
92. he FormBuilder to the server on the Project documents page The link text and a short description of the document can be specified in this case The Attention SEARCH button opens a browser window which enables the user to search through the local file system and to select a file for uploading to the server The selected file initially appears with its com plete path in the text field The SEND DOCUMENT button then starts the actual upload This process should not be cancelled by another action Please wait until the browser window reloads and the uploaded file is listed in the lower overview Only then has the file actually arrived on the server Qualification test a 17 08 2010 20 31 CEST 7 E Karin Mustermann Secu Fla Study 1 17 08 2010 20 28 51 CEST My Account Qualification test Welcome to secuTrial You have to pass the test to be able to enter and edit patient data Download area User Manual User Manual doc 21 KB Regulatory information Regulatory information doc 21 KB secuTrial iAS Berlin 2010 Fig 42 When the participant logs into the DataCapture the user has a reduced menu bar and a new option Qualification test This takes him to the test overview in which he can see the results of previous tests or call up the test In certain projects it is desirable for the participant to first qualify for actual data capture and demon strate a certain basic knowledge To do this the FormBui
93. he content overview You can see a list of the items contained in this question in this case with the No item text item type and related database column Clicking onto an existing item opens it New ITEM creates a new one Copy ITEM FROM copies an existing item and DELETE deletes an existing one Layer Item amp S e C ulr d l 07 10 2014 18 46 CEST Dipl Biol Susanne Schneider Preview Welcome gt Project gt Form family gt Form gt Question gt Item Implementation Project Example study 07 10 2014 18 46 44 CEST Form family Visitenformulare Form Test form Question Some simple questions Type ForzortarRadobuton e reset whos Missing Edit group of option Values labels Displayed Label DB value Value for score calculation order ID Usage 1 yes 1 143 1 2 no 0 144 1 Displayed order 220 Shown no Item Please select one of the following options hide label in form Item HTML o Database column ne e gt CDISC ODM export annotations Contained rules 0 _Cancel _ Save andback Save lt Previous enty top Fig 70 In this example a horizontal radio button which offers defined answer options is created This item type is the simplest to input and evaluate Note Creation types copying After clicking onto an existing item or New Item beneath question you are taken to the next lowest item layer In this window you can create a new item or ch
94. he values Formular 1 4 O user input O display only Msave C Double Data Entry O print O E Signature O Randomization mnpproxform4 25 Displayed No Fig 54 Additional checkbox for Form processing with configurable randomization The randomization form is intended to be used for entering the stratification factors directly with the randomization This enables stratified randomization to be performed in one step and guarantees that the stratification factors used for the randomization are saved exactly as they have been used Additional processing method e signature If the scalable e signature has been set for a project at the form level you can configure with the ad ditional checkbox whether the e signature is requested when saving the data or not This then al ways applies for the entire form If a form is defined as a pure print form the values input by the user are not sent to the server but are printed out in the client s browser using Javascript This form of processing limits the selection of possible and sensible types in the further definition of the form Types which require a server contact for their function such as e g scores are not possible in these forms Such forms may possibly be sensible for enabling the documentation of patient address changes in an appropriate form for the physician As in the pseudonymisation form in secuTrial such personal data should not be pro cessed by the server Once selected
95. his case as a simple property you can Rename the project Distinguish between a national and international project the country is additionally displayed in the DataCapture Extended functions Once the corresponding options per customer have been activated in the CustomerAdminTool the Source Data Verification SDV Discrepancies Transfer Module DTM Data Entry Complete DEC Patient Reported Outcome PSD Double Data Entry DDE and Centre Specific Project Versioning CPV functions are visible in the configuration view If the DDE function is used for a form this function cannot be deselected for the project even if this function has been deactivated for the customer If you activate one of the extended functions this is switched on for the current project However you must have assigned the right to use a function in the AdminTool in order to be able to use this in the DataCapture Note Note Note If you have activated SDV or DEC an additional point called SDV appears under E Signature gt scalable Activate this option so that an E signature is demanded by the system each time SDV is done When using CPV this setting must first be activated in the FormBuilder before this function can be used when editing projects in the AdminTool or capturing data in DataCapture If this function has been deactivated for the current productive project after being previously used when the project is set to productive
96. ich are taken over can either be created on the indi vidual field layer via rules or for an entire form If Everytime the whole form is activated all fields are filled with the values which were saved during the preceding visit or in the previous examination of an adverse event on initially opening an unsaved form in the DataCapture This value take over can be limited by selecting Whole form but only if the days are equal Value take over in RepetitionGroups only functions if the Value take over for whole form option on the main form layer is selected If you create a form in the adverse event form family you can define whether this form is to apply to serious adverse events Test forms can also be created in a subform form family Test forms are required for a possible qual ification test Not all form elements are available in such forms Also see chapter Qualification test for more detailed information Rules and validation The behaviour of internal validation can be controlled here In this case the options can be com bined as desired The Mark mandatory rule based fields option can be used to define whether any mandatory fields i e fields which have to be filled in by specifying a specific rule are to be marked with a red asterisk or in this form Fields with the rule nput required are then marked with a simple asterisk fields with the rule Input required if are marked with a bracketed asterisk In th
97. ient variables and with visit entry in the file from the visit column A dataset for import ing can then consist of 1 n rows of the import file Type 1 Type 2 moche mg sme om 15 02 2013 green i2g 28022013 yelw b4mg Example 1 columnwise export Date Type abc123 01012003 ed mg 14 01 2013 bue Om 15 02 2013 28 02 2013 Example 2 line by line export Fig 59 Ifthe import format is configured accordingly these two import files would import the same data Mapping Name Special import Data record identifier by patient variable Pat ID Add ID Lab ID by form field New data record identifier Number format german number format decimal sign Text comparisons case insensitive for variables case insensitive for option labels Mass import Allow mass import needs at least one CSV Parser Parser Listing Parser listingParser y Assign operator Text delimiter New parser Mapping entries 5 No External variable Internal variable Date format Import unit Option mapping Delete External option Internal option h fra PatlD Bith lt bithdates dd MM yywy 7 Delete REN a lt Ignore gt xl Delete 3 fein o PD Weight lt weight gt y Delete 4 ede o PatlD Sex lt gende y Eoo feme Delete Delete m male 2 Delete New option mapping 5 hod X Pap Blood sample taken lt blood gt Po yes Delete
98. ion can be performed here separate for queries and comment aries Exceptions include questions which are only used to accommodate description texts and do not therefore have a database link e g ASHeadline no menu is ever displayed in this case If Questions and comments are not contained anywhere in a form no buttons are displayed in the form header to display the related overviews Description refers to texts which provide notes or explanations on directly filling in a question These always appear directly beneath the question text There are no description texts on the item layer see below instead there are two layers of descriptions which can be used freely In the second description text you have the option of using separate HTML formatting Under Help text the text which appears in a small additional window when HELP is clicked next to a question in the DataCapture is stored This button is only visible if a text is actually stored The text can be formatted with HTML tags which enables e g paragraphs bold and italic type or links to ex ternal static pages Hide in DataCapture If the question is no longer to appear in the DataCapture the option Hide in the DataCapture can be used After setting the option and saving again the selected question is no longer visible On hiding this question is no longer included on recalculation of the completion or SDV status of a form Hidden questions are displayed with a dashed red borde
99. ion of scores linked AND conditions as bracketed calculation The arithmetic operator of the first AND of an AND group will then be used as the arithmetic operator to the external OR group see also Product description Il FormEngine In the content overview g A new condition can be created by clicking on New OR coNprrioN or New AND CONDITION You can then create and save the conditions see the next chapter Click on DELETE to delete an existing condition Some rules only permit the creation of OR conditions This includes e g the calculation of date scores In this case only the button for creating a new OR condition will be offered For adopting values dates and all score rules in addition to the execution conditions definition of the adopted values or the calculated value the preconditions can also be defined see next chapter 4 10 Layer Condition Overview Nomenclature and mathematics In order to create the condition it is important to be able to roughly categorise the terms parameter value compare value and compare operator Here is one example rule If the patient is 65 years or older a red warning light flashes Now to the individual variables The parameter value is the value on which the rule s applicability or not depends In the example this is the age If it the age the parameter value meets a specific condition the rule applies Note The compare value is the value with which the c
100. is used for navigation between the various registry cards in the pa tient overview A Row label before label from item optional As soon as you have selected a Label from item in the visit plan you can define the row label before the label from an item In the Data Capture this text is displayed above the form family name As soon as you have defined and saved the selected item in the form its contents are displayed above the form overview of the corresponding visit One item can be defined per visit see section Configuration of visits New visit This text is displayed as a button for creating a new visit and as the title on the following page information on creating a new visit Here you can specify a text which is to be shown on creating the next visit for a patient New visit Text before repeatable visit group This text will be displayed in front of the name of the next repeatable visit group By entering empty spaces no additional text will be displayed New visit Text before next scheduled visit This text will be displayed in front of the next scheduled visit By entering empty spaces no additional text will be displayed New visit Text before possible unscheduled visit s This text will be displayed in front of the respective names in the list of unscheduled visits By entering empty spaces no additional text will be displayed In cases where no text shall be displayed at all this can be
101. isit IV Display Check data as checkbox Iv Display of the next step selection on the save confirmation page Adverse Events Converting from AE to SAE via rules Preselection of AE or SAE Adverse events can be added in random even unchronological order T Display question for adverse events on the save confirmation pate M Preset event date with current date Overview layout Form family C Form icon display IV Display the visit plan date Iv Display the entry date T Visit plan first displays only last visit and a link to show the previous visits Projectspezific labels vist plan Label for the overview tab Default Next visit Next visit Default Information for the i creation of a new patient Default Information for the creation of a new visit Default max earliear No Label Type Time lag days to the date of later Label from item fi fk vist 0e Penile fi ew ll Kec p fit vist O hee A o e previous scheduled vist gt s 20 20 lt Plessechoose El B Rv 0 hee mE previous scheduled vist gt s 30 80 lt Please choose gt y ho fi vist wfe El Please choose gt El New visit Visit plan preview form family Form 1 visit 2 visit 3 visit 4 visit Base Examination Personal Data mnpprobpersdata iv v O n Diagnosis lt mnpprobcatalo gt o iv iv Iv Referenz lt mnpprobpersdata2 gt r r O r Medication Concomitant m
102. izations A blinding list must be imported for every randomization The import is carried out in the AdminTool of the respect ive area setup productive For faster access to the related randomization buttons in a project all randomization buttons are lis ted with item text and column names after the general configuration By clicking on the link the item editing page is shown in the main window Missing Values Here you can configure if the option Missing Values is used never always or scalable In addition it is also specified whether an item marked as missing should be considered as complete for the completion status of the form The following options are pre defined for this function Icon Label MV Status v Value exists default amp Value not collected 2 e Value not collected due to rule 3 e Other reason for missing value with manual text field 4 The labels can be edited for all languages configured in the installation see Fig 24 Note The value option Other reason for missing value is optional It can be configured for the project checkbox add reason text field whether this option should be offered in the MV editing window Missing Values C never always scalable M add reason text field M consider marked items as complete Label Value exists gt Default Value not collected gt Default Value not collected due to rule Y German Wert wegen Plausibiltatspriifung nicht erhoben Reset E
103. l Susanne Schneider Welcome Project DB schema user Last DB modification 17 08 2010 19 55 05 CEST Type Registry Q Part project Version Development Release By Vers label C Vers no 2 Last vers modification 17 08 2010 19 59 57 CEST Project name PT Extended features Source Data Verification M Discrepancies Transfer Modul M Data Entry Complete Region C national international Additional patient ID Add ID no only for AdminTool C additional to Pat ID C instead of Pat ID Y Audit Trail amp History only changes C complete Audit Trail Prerequisite for form freeze C Review A Review B C Review A B Automatical query answering no C yes E Signature never C always C scalable Usage of randomization function Cno yes name of group A A name of group B B Base for uniform distribution Centre Project Pseudonymisation paper based external patient list via PlDDispatcher b compose entry form e Bundled message dispatch Cno yes Notification at New notification Query asked Query created _ Delete Cancel Save and back _ Save top Fig 22 Project configuration page An entire range of further additional functions which can be used to influence the DataCapture tool s displays and work flows is available on the project layer These functions will be explained here On this page you have the option of setting simple and complex project properties In t
104. lan arm via a discontinuity criteria prematurely and change into another visit plan arm the negated discon tinuity criteria has to be included into the precondition for the premordial arm If the discontinuity cri teria is true the visits for the premordial arms can no longer be created whereas the visits for the next arm can regular arm A with condition critera1 a and discontinuity criteria yes following arm S regular arm B with condition critera1 b und discontinuity criteria yes folllowing arm S special arm S with condition discontinuity criteria yes previous arms A und B definition of visits in FormBuilder in the sequence A B S or B A S In an initial visit without arm the criteria1 is checked and the distinction between arm A or B is made After that the visits for arm A or B are created Either the discontinuity criteria is checked in every visit or it is possible to use an unplanned visit without arm to check this criteria If the discontinuity criteria is reached the following defined visits of arm A resp arm B cannot be created any more but the visits for the special arm S are created instead Via the triangle button you can change back and forth between the visit plan editing page and the treatment arm rule definition page You will be asked to confirm whether you really wish to change pages Treatment arms can be subsequently deleted even if visits have been assigned and created in
105. lder enables the creation of a qualification test consisting of simple multiple choice questions Only after passing the test can the participant re cord and edit patients 17 08 2010 20 34 CEST t Admin Istrator seculrial Participants Centres Projects Roles Resources Patients Locations Countries Design AdminTool All participants 4 candidates 43 active and 4 inactive participants Display inactive projects Select project lt all projects gt uomen Select centre lt all centres El Select status lt all status gt gt Search for participant Y po Search Reset Page 6 of11 gt ID Name UserID Status Location Staffer Centre Role Project Patients 1161 Muster M ller Manfred 51 active no Data Manager Study 1 PROB O unlimited 1178 Mustermann Karin karin Candidate na Centre B PROB Clinical Investigator D unlimited 1164 Mustermann Manfred H3 active no D unlimited 1183 M hlhausen m llerzwo inactive no Berlin2 IAS1 Observer D unlimited 1186 m ller 2 active no D unlimited New participant 150 885915 Export Import Cleanup top Fig 43 Participant overview in the AdminTool with specification of the test status The status of the participants is administered in the AdminTool candidate active or inactive There it can be seen which participant has already taken the test and whether he has passed it Explicitly setting the status on the participant editing page is also possi
106. le evaluation in the 1st visit When defining rules of the type Take value date from for subforms beside previous repetition as a reference for subform values previous saving can be specified as another source Previous repetition will not be evaluated for Take value from rules when opening an unsaved main form for the first time This means that the values will not be taken from the previous repetition the first time that the unsaved main form is opened The procedure for adopting values is executed when creating a new repetition via the More button for the repetition group Previous saving can only be selected for Take value from rules in the sub form both for defining the adopted value and for defining preconditions It is only evaluated when opening the unsaved main form When subsequently adding repetitions these values are ignored Difference operators Normally as described above two values are always compared The compare operators Difference less than Difference greater than offer the option of initially forming the difference between two values and then comparing the result with a third value by means of the described operator This op erator type is only permissible for numerical fields In this case the second specified value is always subtracted from the first The third compare value can only by specified as a fixed numerical value This enables e g the development of a value to be checked ov
107. led een Mean lt preceding visit gt 1 gt New visit group New visit Visit plan preview Fig 30 Configuration as centre specific visits highlighted in a project with patients in multiple centres Hiding You can hide visits which have already been set to productive mode Hidden visits will then not be displayed or created in DataCapture Data which has already been gathered in these visits will re main intact but is no longer displayed If these visits have already been created for patients the visit numbering for these patients remains unchanged the hidden but created visits will also be also counted If visits are numbered in se quence in the label hiding visits may cause gaps in the numbering With new patients and when creating new visits the hidden visits are ignored also with the number ing When comparing patient visit plans that were created before hiding visits with the same num bering can no longer be directly compared Assigning forms For every visit it must be determined which forms are to be displayed there By default newly created forms are not displayed After creating forms they must be adopted here in order for them to also appear in DataCapture Which forms are displayed in the respective visit can be selected in the next level via the checkboxes When using automatic visit numbering different positions of visits in different arms are indicated with multiple numbering de Numbe
108. lt Parser 0 Delete New import format Cancel Save and back _ Save top Fig 58 On the import formats page all previously created formats are listed in the upper part For editing purposes an existing format can be selected or a new format can be created Editing is then carried out in the lower part of the page see below After clicking onto the New IMPORT FORMAT button you can edit the properties of the new format in the lower part Name The new import format first has to be given a name e g the name of the device This is dis played in the DataCapture Data record identifier Via patient variable One two or three variables which identify the patient can be specified as an optional field for an import format If such a field is specified the value specified therein is compared with the current patient The two variables search for the patient via the pseudonym Pat ID the additional ID Add ID or if configured in the CustomerAdminTool the Lab ID If only one variable is specified searching is only carried out in this field However the patient which is found must be unique If several variables are specified and various patients are found via this this represents an error Via form field One further optional field is the data record identifier The value the variable defined via the data record identifier an item from a form is compared with the values in the forms to identify a specific form The fo
109. ly also see Product Description Definitions In the DataCapture adverse events are shown on a separate tab in parallel with the visits and the casenode forms A special form family which can be created exactly once per project is therefore available for these events Within the adverse events a further distinction is made between simple adverse events AE and Serious adverse events SAE Accordingly forms within the adverse event form family can also be identified as SAE forms ATTENTION If no SAE form is available it may be impossible to create SAEs in the DataCapture under certain circumstances There are two different options for handling the occurrence of AEs and SAEs in the DataCapture 1 Converting from AE to SAE via rules Initially the participant always completes the normal AE form s The rule Open Serious Adverse Event if can be set on one of these forms If this rule is fulfilled the event initially created as an adverse event is transformed into a serious adverse event and the SAE forms are displayed in addition to the normal AE forms If nothing has been expressly specified for a project this is the default setting 2 Preselection of AE or SAE With this setting the participant must decide when creating the adverse events whether this involves an AE or an SAE Depending on selection either only the AE forms or only the SAE forms are displayed Note As a rough schematic the procedure is approximatel
110. ly processes the values of the second line Variable names contain no blanks text delimiters separating characters or assignment characters If a text delimiter has been defined values within the text delimiters are regarded as text values Blanks within text delimiters are not then interpreted as separating or end characters In addition the character for separating and the character for including values are specified in the parser This is particularly necessary for interpreting text values In the case of the listing parser the character for the allocation of variable and value is additionally specified instead of the separating character The equals character is used here as the default A name to identify the parser is specified for the user If the user has access to several import formats for one form the user must select an explicit format and the parser on import Repetitions Imports in repetition groups is possible by columns or rows When importing by column the dataset for the main form will be entered in one row The contents for the repetition groups will then be entered in repeating columns To distinguish between the columns an extended identifier is defined for the import format This extends the subform item column headings which are defined as external variables together with the repetition number When importing by rows the dataset is not created from a single row but from the change in the identified pat
111. mode again all centres will automatically work with the most recent project version Wherever possible these functions should not be changed during productive data capture for a project Whilst creating a project you can test which functions are appropriate and sensible for your project in the setup area prior to initial release Patient in multiple centres For projects it can be defined as usual whether patients can participate in only one centre of this pro ject or whether they can be entered into multiple centres In this case patients are created in a centre as normal This is also stored as the home centre in the casenode entry These patients can then be subsequently assigned to other centres Depending on the role rights of the centre parti cipant the patient can be viewed and edited in all of his or her centres If the patient pseudonymisation is conducted via an external patient list either using a PIDDispatch er or directly see above that the patients can only be included in other centres if this is done via the external list If this is selected when creating a patient in DataCapture there will be no option to select between creating a new patient or including an existing patient After filling out the entry form the patient will be automatically assigned to the selected centre if the patient has already been cre ated in another centre If the pseudonymisation in FormBuilder is changed to paper based after se lecting thi
112. ms for the last existing visit Visits can not only be entered in chronological sequence but can also be created at an earlier point in time Unscheduled visits can be created in any sequence including non chronological The period of time in which the entry date may deviate from the relevant current point in time may be defined in days If a specification is missing any deviation in the direction is permissible By specifying 0 for example you can subsequently prevent an entry date in the future from being specified whilst any dates in the past are permissible A patient s entry date should be set to the particular current date as default Free and unscheduled visits should be preset with the current date Configuration of handling of forms With the settings for the handling of forms further configuration options are available by marking the corresponding check boxes After the participant has created a new visit the first form is opened for data entry A check data check box is displayed in each form If this check box is deactivated in the DataCapture the participant is able to save forms even if these contain incorrect data rule violation In addition to displaying the check box it can now be defined whether the check box should be preselected when displayed in the form or not With the option unchecked the form can always be saved in DataCapture the first time round even if errors har
113. n the case of the following tags it must be noted that they must usually have one tag at the begin ning lt x gt and one at the end lt x gt of the marked section hence the notation lt b gt Bold lt b gt lt i gt talics lt i gt Paragraphs Break A return is activated with lt br gt at the end of the line Attention Contrary to the rule a break must never be closed with a second tag lt br gt REI Paragraph Alternatively enclosed paragraphs can be identified with a p before and after the para graph lt p gt lt is best to compare the result in the preview at an early stage p 5 2 Reserved words Comparisons are done case insensitive WebObjects BETWEEN NOWA TI DESCRIPTION BY n LEVEL CHAR NUMBER NAME ri 25 RELATION CLUSTER A RELATIONSHIP oe 3 STE COMMENT ONLINE A COMPRESS OPTION TYPE CONNECT OR CREATE ORDER secuTrial CURRENT PCTFREE ADVERSEEVENT DATE PRIOR AEFOLLOWUP DECIMAL PRIVILEG ATCN DEFAULT PUBLIC ATCVP DELETE RAW ATSDV DESC RENAME CASENODE DISTINCT RESOURC CASEVISITPLAN DROP
114. n the letter can additionally be input The Show preview link can be used to check the design of the patient letter in a separate window Of course it does not yet contain any patient data in the preview These are indicated by the place holder Project documents Ti t 17 08 2010 20 20 CEST Sec u ria r int Dipl biol Susanne Schneider Opening User Manual doc Nelcom My Ac You have chosen to open Welcon W User Manual doc which is a Microsoft Word Dokument 598 kB This is the opening page for data entry It serves as a central poir From https Jasp staging interactive systems de there are any new messages these are displayed in a new windc ES At the top left you can see your name and the current date Alwe in to the wrong account The LOGOUT button here and in other w Please log out whenever you leave your computer so that nobody Save File contact with the server you will be logged out automatically time Open with Microsoft Office Word default From your user ID the system recognises which centre s you h create the according patient record In order to access an already Lab ID into the free text field Then click on SELECT to view the By clicking on the HELP Button you will always receive additiona page From anywhere in the program you can go back here by clicking on the WELCOME button Download area L i User Manual doc 21 KB Regulatory information Regulatory information doc
115. nals an appropriate printing width in A4 portrait format for the form layout green printable yellow only printable if scaled down red only printable if extremely scaled down This is only an estimation The actual printed copy can still be influenced by selecting another paper format or using the enlargement reduction function in the browser Properties In the main area Here you have the option of naming the family under Form family name In the form overview the different types of form families are depicted with partially different colours via the file card tabs In this case normal clinical forms are called Visit because they are each assigned to one visit Case nodes are form families on the status of a patient in the DB patient per project casenode these are subsequently created e g for address or centre changes and departure from the project Ad verse Events are responsible for adverse events the mage form family enables the clear presenta tion of forms with images Subforms are for the creation of repeated questions RepetitionGroups see Product Description Il FormEngine If multiple casenode families are defined the forms of the family will be displayed in separate casen ode tables in the form overview of the DataCapture The tabs are labelled with the names of the cor responding casenode family and arranged in the order of the families Image and adverse event form families can only be created
116. nce on the window struc ture with the header and footer The centre part is therefore the form in the stricter sense which again has a typical structure 2 3 Form structure A secuTrial form has typical elements some of which are present in each form or which can be used optionally The way in which these elements appear in the DataCapture and how they are des ignated in the FormBuilder nomenclature is described here A good knowledge of these standard elements and their positioning plus the related field in the FormBuilder is important in order to 1 compile the data records sensibly 2 fillin the correct fields on creation in the FormBuilder The elements can be reflected in the following breakdown Form number form name plus form description Intermediate number intermediate header Question number questions plus description and help text Item number item Possible answers e g labels for radio button Project EuroPa County Germany Welcome Help Logout uroPa Date 13 03 2003 14 43 Center TestBerlin1 Sebastian V ltz Patient qwn582 Back D Current Drug Treatment For general help on completing this form see the first Help window at Current Form description T Current treatment of parkinsonism Intermediate header Current treatment of parkinsonism Help Comment C yes C no Query 1 Levodopa preparations Question text Comment if YES specify below Query nul cC yes C no 1 L Dop null yes no
117. nditions are fulfilled For a better understanding the previous conditions are called execution conditions with these rules Preconditions are displayed in an additional column in the data record tables next to the execution conditions On the editing page in FormBuilder the difference between the Precondition and Execu tion conditions for these rules is listed in the breadcrumb trail Types Rule name AAA AAA eee Sequence position 10 Parameters for the calculation ignore this value during calculation 3j calculate only when maximum number of this uncounted values post decimal positions l fe Preconditions 2 Position Error message Operator Comparison value Question Delete from database fo fi0 and greater than value fixed double Delete 0 Newandcondition less than value fixed integer Delete New or condition Execution conditions 2 Position Error message Operator Comparison value Question Delete from database fo fio and add value Item Question 1 Eingabe 1 n1 Delete 0 Newand condition add value Item Question 1 Eingabe 2 n2 Delete New or condition Fig 83 List of preconditions and execution conditions for a score rule It is also possible to define multiple value adoptions or score rules for the same item For example in order to calculate the body mass index for men and women based on the entered gender pre condition two different calculation rules can be defined for the same
118. ndividual visits and the general configuration of the visits are listed simultaneously Forms All of the forms are described in their own table sheet Direct form properties and configurations are listed row by row in a section at the beginning Only the properties which have actually been con figured are listed The questions and items are listed below each other row by row in the same order as in the form The information on the properties of the questions and items is listed in columns for each row The listed properties are No of the question Question text italic text search text Description first row 1 Description 2 Row 2 Description Question type incl configuration SDTM domain No of item item type incl configuration Database column or unique name within the form SDSVarName Options separated by semicolons lookup table Unit format Rules messages are displayed below the form Rule conditions Validation type explicit output of the use hard rule saving only possible after deselected Check data checkbox form status with errors or soft rule saving after confirmation form status with warnings Error messages Help text Display query menu Display comment menu Notes always empty intended for subsequent editing of the file Subforms are indicated by an interim row inserted below the repeti
119. need to enter a URL or the executing participant Welcome gt Project Project Example study 03 06 2014 18 35 40 CEST Edit import configurations Example study 4 Identifier Description Delete from database Visit date This is a first test import configuration Delete Visit label with date Delete Visit label without date Delete Visit nunber Delete Neue Import Konfiguration Identifier Visit date Description This is a first test import configuration Patient Identify patient by Pat lD pide ab Allow patient creation Centre eene Visit Identify visit by Visit label L Visit number Visit date fvistdate dd mm yyyy IV Allow visit creation New visits strictly according to project visit plan e Adverse Event Y Identify adverse event by Number Date E 7 dd mm yyyy hh mm Followup date dd mm yyyy hh mm Repetitions Column by column with token ldentifier External variable No C Rowby row Cancel _ Saveandback _ Save top Fig 32 Editing page for the import configurations of a project In order to analyse the file entries the following column headers must be entered In some cases the import format information contained in the forms will be overridden Patient identifier To identify a patient in an import file the appropriate column headers are needed It can be configured to automatically
120. ng import The specified format names or external variable names are not checked as regards a specific format or uniqueness A check is only carried out to determine that no characters defined for the parsers are contained in the variable names Properties In the main area You have the option of naming the form under Form name overview In the DataCapture this name appears in the form overview In contrast the Form name title appears in the heading of the form itself This enables short names to be assigned for the form overview if necessary no line break Processing defines the types explained above Input fields are available for specifying the database table and column names for items see below A few basic aspects have to be noted in this case No distinction is made between higher and lower case letters in this case preferably write everything in lower caseletters A Only normal letters numbers hyphens and underscores are permissible no blanks no special characters Column names must begin with a letter Certain names are not permitted by the system if in doubt you will receive a corresponding error message E g alter is a word reserved by Oracle and must not be used In this regard refer to the Annex Table names must be unique within a project Column names must be unique within a table A corresponding name prefix is specified by the system for tables this con
121. ng the triangles at the start of the line Button line Contains CANCEL SAVE AND BACK and Save plus Top in order to return to the start of the page in the case of longer pages There are also the two buttons PREVIOUS ENTRY and NEXT ENTRY if multiple elements exist on the re spective level form family form question or itemlevel between switching is possible Before leav ing the page a confirmation dialogue box will appear if entries on the page have been edited but not saved Note Display of rule references If a project has not yet been set to productive mode a specific item can often no longer be deleted as another item s rule refers to this item To display the corresponding reference click onto the not deletable because of references link next to the item which cannot be deleted A pop up window now opens The question with the corresponding rule is displayed in this By click ing onto the question this opens in the main the FormBuilder window 2 FormBuilder 3 4 0 6 Build 442 iAS Mozilla Firefox https buildserver ias locallapps WebObjects ST34 setup FormBuilder woa 1 wo 9PWTD9GCEa6RsJ 7 Undeletable element Project Study 2 17 08 2010 19 38 33 CEST IASI Regi Form family General Examination Form Personal Data External references Form family General Examination Form Personal Data 2 mnpias1 persdatal gt Question Pregnancy Item pregna Imnpias1pregnant 10 pu
122. ng versions of this project are listed below The migration into production of this project will be done at the following time 04 06 2014 03 30 CEST Undo release Fig 20 The release of a project can be undone on the release page Data record tables Using the DATA RECORD TABLE button will open a popup window with which the data record tables used in the project can be exported in Excel format Ti e FormBuilder lt dev version gt iAS Mozilla Firefox oxi se C u ri a e 07 10 2014 18 36 CEST b http sus2014 apps WebObjects FormBuilder woa 5555 wo ftxWUutb Welcome gt Project Data record table Example study q W include HTML tags a Tiie je i i d Cancel Create data record table DB schema user IAS0 Last DB modific Type O Registry Part projec Project name Example study Version Development Relea Vers label Vers i Fertig eee ol xe z Setup Export Import Export import project setup Release Release Fig 21 Select the distribution of the data record table via a popup Before downloading you can select whether all of the table sheets are created in one file or whether they are to be distributed into different files This may be necessary because Excel tables with a lot of content cannot be displayed in the correct format When the documentation is distributed to mul tiple files a table of contents is also created as a text file In the form overview of th
123. nglish Value not collected due to rule Default French Value not collected due to rule Default Reset all Other reason for missing value gt Default Fig 24 Configuration options for missing values at the project level Pseudonymisation A patient can be either pseudonymised on a paper basis in which case the personal data are only entered in a print form which is not sent to the secuTrial server in order to guarantee data privacy or the patient can be entered in an external patient list additional database outside of secuTrial also see psx manual 1 1 pdf and receives a pseudonym from the patient list For paper based pseudonymisation a form can be compiled from a list of individual entities this must be filled in accordingly on creation of a new patient The data are printed out via Javascript in the client browser Connection to an external patient list is carried out either via the selection of the PlDDispatcher which processes communication between the DataCapture and the patient list The PIDDispatcher is integrated into the DataCapture user interface so that patient entry barely differs for the participant The URL for the PIDDispatcher is entered for the relevant project in the AdminTool Another option for the pseudonymisation is the external patient list direct which enables the linking to an external list for pseudonymisation and saving the identifying patient data like the Mainzelliste developed at the Univer
124. nswered automatically as soon as the value for which the query has been submitted is changed However this is only carried out if the participant has the right to answer queries This function also applies to imported form values The default answer text is Query answered automatically due to value change If the DEC work flow is also configured the explanation specified by the participant for the value modification is at tached to the automatic text On use of the E signature for form modification or answering queries a corresponding note is dis played prior to saving if a query is automatically answered and the E signature will be requested Withdrawing Queries You can activate the withdrawal of existing queries here The query remains intact but it can no longer be edited Queries which have been withdrawn are no longer taken into account when calculating the query form status see DataCapture When this option is selected the pop up window for query editing in DataCapture will feature an additional withdrawal option for all participants with the right to ask or resolve queries Query menu comment menu Here the display of queries and comments can configured at the project level The available configuration options are always never and scalable If scalable is selected then a configuration can be performed on the next level below E signature The input of an E signature for saving forms can be A Generally excluded
125. ntrally in the form see Form Rules and validation If the absence non completion of an answer is to be marked as an error a separate rule must be created for this in the FormBuilder field must be completed Only then is the empty field handled as an incorrect or impossible input during the form check Note The rules available in the FormBuilder also enable individual answers to be defined as not required or not required under certain conditions In this case the answers are then ignored during the com pletion check A form is marked as completely filled even if the corresponding entries are missing Incorrect or excessively strict rules may also lead to the fact that a form is regarded as incomplete although all necessary and sensible entries have been made from a content point of view Creation types a seculrial 17 08 2010 21 16 CEST Dipl biol Susanne Schneider Preview Welcome gt Project gt form family gt Form Question Item Rule Project Study 1 17 08 2010 21 14 30 CEST Form family Base Examination Form Personal Data Question Patient description 1 Item Birth Type Input impossible if Ir only as confirmation Rule name Sequence position 10 Rule conditions 1 Position Error message Operator Compare with value Question Delete from database fio This person seems to be too young for this study greater than value current date timespan Delete New condition Cancel Save
126. oject is irrevocable After the release the project cannot be edited any longer An already existing productive version ofthe project setup will be archived during this process The existing versions of this project are listed below Productive version No 3 from 16 03 2010 10 47 06 CET LP3 Visitenplan ge ndert Admin Hobby lt admin gt Archive version s No 2 from 16 03 2010 10 33 48 CET LP2 Neuer Versuch Referenzen Admin Hobby admin No 1 from 16 03 2010 09 42 25 CET LP1 Erster Test f r Darstellung von Regelreferenzen Admin Hobby lt admin gt The migration into production of this project will be done at the following time 18 08 2010 03 30 CEST Release Cancel top Fig 19 Release of a project Once you have ascertained in the test area that the project contains no further errors it can be re leased respective transferred to productive mode This means that you can no longer change the ex isting configuration but can only add forms or components Specify a version label for this The following characters are permissible A Z a z 0 9 blank point hyphen underscore The first character of the label must be A Z a z or 0 9 The assigned labels must be unique for all project versions The reason for release must then be entered Both data sub sequently appear on the project overview Then click onto RELEASE The release must be confirmed once You are then returned to the project overview
127. on can be defined for this If you would like to carry out a format check in text fields assign the field with a rule to which a con dition is linked e g Input only possible if Limit reached if Now create a new condition Under Parameter is read from click onto Own item and select a Compare or Assign Operator Specify text format as the compare value You now have the option of defining the corresponding format An explanation of the characters to be input and their meaning e g C for an arbitrary letter can be obtained by clicking onto the ques tion mark Once you have defined your format you can check it using the Test button in a small separate win dow Note Sequence position 10 Error message Birthplace code is unknown Parameter is read from own item C this item Compare or Assign Operator unequal value z Compare Value text format z Compare Value UUUUUUUU feri format Test Fig 82 In this example the input in the text field is only possible if 8 capital letters are input Preconditions and execution conditions For adopting values date score and all score rules in addition to the execution conditions definition of the adopted values or the calculated value the preconditions can now also be defined Precondi tions are defined in the same way as other rule conditions e g Input only possible if The adoption or evaluation will only be performed if the preco
128. once for each project Displayed order offers the option of sorting several form families which impacts on their presenta tion in the DataCapture The required numbering for the form families means that you must subsequently define the order even for sub forms However this will only be necessary in FormBuilder Like the name of the casenode and the image family the name of the adverse event families is also used as a tab text in the form overview In contrast the text for the visit plan tab is configured in the editing page for the visit plan If the forms of a form family are not assigned to any visits or are completely hidden in DataCapture the form family is marked with a grey cross in the overview under Hidden In the content overview This contains the list of the forms contained in this form family Clicking onto the name of a form opens it New creates a new one and DELETE deletes an existing one SHow opens a new window with the above described form preview If a form is not assigned to any visits it will be marked with a grey cross as indirectly hidden in the content overview under Hidden By clicking the button ORGANIZE FAMILIES you can move the forms within a form family The Copy Form FAMILY FROM button can be used to copy an existing form family in order to save work in the case of similar families Only subform casenode and visit families can be copied within a project Copy form family from seculrial 17 08
129. ondition is compared This is firmly specified in our example i e 65 it becomes more difficult if the compare value is not firmly specified but is located in a different field or even a different form but more on this later The compare operator is the mathematical procedure according to which these two values the parameter value and the compare value are compared with each other In the example case 65 years or older the compare parameter is unmistakably greater than or equal to 2 Here again is a summary of the example rule Age 2 65 Parameter value Compareoperator Compare value As can be seen these data do not yet have anything to do with what happens when the rule is ful filled The red flashing warning light has already been defined under Type of rule incidentally no such rule exists in secuTrial Condition values from other fields As mentioned the parameter value can not only be firmly specified but can also be read out from other fields Then it is dynamic and is only defined when the other field has been answered One ex ample If the patient is younger than his disease a red warning light flashes In this example the compare value would have to be read out from a field which states the duration of the disease Let us assume that the year of birth not the age is captured in the current field and form B Disease data contains a field Year of the start of the disease Mathematically the rule is theref
130. ons will inev itably limit the system s performance Never use the browser functions Reload current page Back or Forward Only use the buttons within secuTrial Click on the CanceL button to return to the previous page You can also use the breadcrumb trail in the navigation bar to return to previous pages Clicking on the CLose button will close the pop up window and take you back to the main window Click on the Locour button to exit the application To reopen the application you must log in again with your user name and password Within secuTrial it is not possible to access the browser context menu by right clicking This is de signed to restrict navigation to the buttons and links provided in secuTrial If you have not had contact with the server for a longer period of time you will be automatically logged out of the system This ensures that unauthorised persons cannot access the database or al ter your data entries contact with the server means saving changing pages reloading pages but not simply entering data into a form The exact period of time before the timeout automatic logout is configured on the secuTrial amp server and is usually 20 minutes The time remaining until the automatic logout is displayed in the title line of the browser window If you have been automatically logged out any data which has not been saved may be lost For this reason you should always save th
131. ore Year of birth lt Year of the start of the disease Parameter value Compare operator Compare value from form B In this case therefore the localisation of the compare value additionally has to be specified so that the rule can be carried out correctly The usual reference to the current form is carried out via the data Current visit or Current examina tion If comparison via the data 1st visit examination or last visit examination randomly refers to the current visit or examination form the currently input value is compared with that in the DB Subform values can be referenced within the own subform to the previous repetition of the subform or to the main form Previous repetition relates to the previous repetition of the same sub form in the currently open main form On definition of rules of the type Form input only possible not possible as the prerequisite for edit ing other forms it must be noted that evaluation of the rule is carried out from another form The cur rent visit may then possibly not be that of the rule form but that of the checking form If e g a value comparison is defined via a value from the preceding visit it may occur that the form in the 1st visit cannot be saved without an error message as the 1st visit has no preceding visit and the compare value is therefore always NULL In this case Ignore in 1st visit can be configured for a condition Thus configured conditions are then skipped during ru
132. ormEn gine The condition for a plausibility rule has the following structure Note Referencing the condition via Form to the Own item and Current visit is not possible tem Rue n The execution condition for an initialisation rule e g value take over has the following structure Item al Rule As of 13 10 2014 93 iAS The execution condition for score calculation has the following structure Item t gt Rule Checking for entries which have not yet been saved is only possible via Current visit and the cur rently handled form As soon as other forms or other visits are referenced the database entries are checked This also applies if e g reference is made to First visit and the current visit is the first one Properties 10 Sec ulrial Date 17 08 2010 21 21 CEST Participant Dipl biol Susanne Schneider Preview Print Logout Project Study 1 17 08 2010 21 20 51 CEST PROB Registry No 2 Development Form family Base Examination Visit Form Personal Data lt mnpprobpersdata gt Question Patient description 1 l4SStandardGroup Item Birth checked Date DD MM Y Y Y Y lt birthdate gt Rule Input impossible if Sequence position fro Error message a This person seems to be too young for this study Parameter is read from own item C this item Compare or Assi
133. ou are taken to the next lowest Form layer You can create a new form in this window You can also create a new form by using an existing form as a template for a copy see below The User inputs radio button generates a form for inputting data In this case there are three para meters which affect its processing and are therefore defined in the identically named area Save pro duces a normal form for data capture The analogue variant of this is the Print type This is used to create forms which are only to be printed They do not need any database reference as no entries are saved Pure display forms which do not permit any user inputs can also be defined These are not mapped on database objects instead the fields have to be filled from other forms by means of take over value rules Important In the upper menu bar on all form editing pages there is a PReview button and an IMPLEMENTATION button which directly open the respective view in the preview window Additional processing method double data entry DDE If double data entry DDE has been set up for a project at the form level you can configure the pro cessing method for the individual forms with the additional checkbox This is possible for the visit adverse event and casenode form types Image forms cannot be captured with DDE With subforms the data entries are determined by the configuration of the main form Form name overview Formular 1 4 O userinput
134. ple or more complex project properties Here you can Compile the documentation dossier for the project All selected project parameters project configuration visit plan reports statistics form implementation form preview patient letter pre view lookup tables DB scheme default All can be compiled and accordingly downloaded as a zip file The files in this zip file are stored in html format The background for documentation dossier selection is colour coded and differs depending on the project version grey Archive blue Productive green Development red Released All implementation views can addition ally be opened on line via the Form IMPLEMENTATIONS button These are linked to the editing pages for the individual elements Download the data record table in Excel format see below Download all implementation views Click on the PrinT CRF button to print all of the forms so they can be used as hard copy tem plates The forms optionally contain a header for entering patient ID centre date participants visits and optionally footnote entries location date and signature Displaying these options and separately displaying dropdown list entries logos help and catalog contents as well as lan guage and character set can be selected before printing In addition the size of the included empty fields for text number and date items can be selected between normal medium and wide Repetition groups are DISPLAYED with
135. ply be taken over A Database table Requires the specification of the table name under which the form is to be saved The default value for the specification simply consists of the possibly extended original name This can be freely selected the basic principles which apply are the same as for all table names By clicking onto Save AND Back your inputs are accepted and the form is copied CANCEL discards everything and you are returned to the previous page The property regarding whether a form question or item is hidden or not is lost during the copying process As the newly created copy is not yet productive undesired questions can simply be de leted If you copy a form with lookup tables from another project the lookup tables which are used includ ing all values are copied into the current project The tables are automatically renamed in this case This is also the case on repeatedly copying the same form you then obtain multiple issues of the previously identical lookup table Prerequisites and following actions Prerequisites When opening a form in the DataCapture the defined form prerequisites are first checked before a decision is made as to whether the participant may and can edit the form Exactly one prerequisite can be defined for each form A prerequisite may consist of a rule which has to be fulfilled in another form or of a saving status to be achieved for another preceding form The following rules can be
136. r in the implementa tion view CDISC ODM Export annotations Here the SDTM domains can be selected either directly or after selecting the classification two se lection lists see Fig 48 below The selected domain is then taken over via the SeT button How ever the domain can also be entered manually it must always consist of two capital letters no um lauts or special characters On saving a check is conducted to determine whether the specified domain is contained in the spe cified domains If not a warning message is displayed however the value can still be saved by clicking onto the Save button again YCDISC ODM export SDTM domain DM Special Purpose DM Demographic y Set annotations ntext SDTM Demographic Remove ODM Alias Add Fig 66 Definition of the SDTM domain and the alias elements for a question in the folded out CDISC area The English comment texts in grey beneath the selection lists originate from the SDTM definition and have intentionally not been translated in order to avoid misunderstandings due to formulations I gt CDISC ODM export annotations SDTM domain DM 1 ODM Alias Hide in the DataCapture rea Fig 67 View of the CDISC area folded in The domain and the number of defined aliases are only displayed as text lt Please choose gt lt Please choose gt lt Please choose gt Events General Observation Class AE Adverse Events Findings General Observation Class
137. r of visits displayed side by side on this page settable from 1 10 10 Start Mid TA1 Mid TA2 5 visit 6 visit 7 visit 8 visit Ungeplant 5 visit Form family Form 4 visit 2 visit 3 visit 4 visit TA 1 A A A TA 1 TA 2 Visite Formular 1 1 lt mnpproxform1 gt J s n O n Kontaktinformation Druckform 9 E Formular 1 2 lt mnpproxform2 gt iv is p p O Formular 1 3 lt mnpproxform3 gt O Y Formular 1 4 mnpproxform4 7 BA Form 1 1 lt mnpproxbal gt BA Form 1 2 mnpproxba3 BA Form 1 3 lt mnpproxba4 gt E BA Form 1 4 lt mnpproxba5 gt F i Y Ungeplante Visite BA 1 lt mnpproxungeplantbal gt O v Mid TA2 End of Treatment F family F B visit 7 visit B visit orm family Form TA 2 TA 2 TA2 9 visit 10 visit Visite Formular 1 1 mnpproxform1 D Kontaktinformation lt gt a m Druckform D O a F E Formular 1 2 lt mnpproxform2 gt Y Formular 1 3 lt mnpproxform3 gt Formular 1 4 lt mnpproxform4 gt Y BA Form 1 1 lt mnpproxbal gt O BA Form 1 2 mnpproxba3 BA Form 1 3 lt mnpproxba4 gt BA Form 1 4 lt mnpproxba5 gt Y Ungeplante Visite BA 1 lt mnpproxungeplantbat gt Y Fig 31 Editing matrix for assigning visit forms In the visit plan
138. racetamol FormBuilder 2 Aspirin FormBuilder 3 ibuprofen FormBuilder New value Cancel Save and back Save top Fig 45 Overview of lookup tables Separate lookup tables can be defined for each project The user of the DataCapture tool can there fore be provided with selection options in the form of drop down fields As lookup tables are always defined for an entire project re usability is given in the case of frequently occurring selection options e g between never rarely frequently etc There are three different types of lookup tables Simple lookup tables are designed as a simple option for choosing between self defined values This type of lookup table can be linked in a hierarchy e higher level tables can be defined for combined display in lASMultipleSelection or ASCombinedSelection question components Extendable lookup tables can be extended by the participants by clicking on the corresponding OTHERS button Personal values can therefore be entered and transferred instead of the specified ones Extendable lookup tables cannot be specified as higher level tables The hierarchically linked lookup tables are particularly useful in the case of causally connected op tions After selecting Pregnant from table A for example it should be possible to select in table B the length of time for which the relevant person has already been pregnant gt 12th week etc Various prerequisites must then
139. re allowed Hint the creation of an big catalog may take some time and slow down the performance of the FormBuilder for all users during the processing Select the file for upload Durchsuchen 150 8853 15 Upload Cancel top Fig 10 Selection of the catalog file to be imported Search through your file system for the catalog to be uploaded and select a character code before uploading the catalog On creation of a new catalog and also subsequently the designation of the catalog the layers and the individual entries can be edited The internal table names are derived from the catalog name A waiting page is displayed whilst saving and creating the catalog After sav ing the uploaded catalog can be used in all forms for this customer a Se C ulrial Date 17 08 2010 19 43 CEST Participant Dipl biol Susanne Schneider Logout Welcome gt Catalog list Edit catalog Access customer last changed 17 08 2010 19 43 CEST changed by Dipl biol Susanne Schneider Catalog name PartofICD10 Beispiel Ausschnitt ICD10 csv catalog data is not yet saved Layer 1 ICD10 Chapter contains 2 entries 10 Chapter No kapnr 20 Chapter Title kaptitel Layer 2 icDi0Geups contains 3 entries ho Group from oo o wowputo abs Layer 3 ICD 10 contains 26 entries 10 Norm Code normcode 20 Title titel Cancel Save and back top Fig 11 Editing the layers and entries after uploading a catalog CS
140. reates a new one and DELETE deletes an existing one Layer Group of labels Overview For radio buttons popups as well as for radio button matrices and check box matrices a group of la bels must be compiled in the FormBuilder The item type and the relevant database column must be specified first plus a relevant question text if desired This must be saved and the group of labels can then be edited Type Herzonta Radobuton resetoption wthot y M Missing Values Edit group of labels e nd Label DB value Value for score calculation ID Usage 1 yes 1 143 2 no 0 144 3 perhaps A 145 Fig 75 Excerpt of the editing page of a horizontal radio button Via the link Edit group of labels you have access to an subpage to create and edit labels Important Create new label edit label a S e C ulr a l 07 10 2014 18 49 CEST Dipl Biol Susanne Schneider Welcome gt Project gt Form family gt Form gt Question gt Item Project Example study 07 10 2014 18 48 29 CEST Form family Visitenformulare Form Test form Question Some simple questions Item Please select one of the following options Edit group of labels Some simple questions Please select one of the lt hrb gt Already used labellings should not be changed contentwise No text DB value Conversion factor 1D Usage Delete from Compilation n 71 yes 1 143 1 Remove p no 0 144 1 Remove B E erhaps A 145 1 Remove New label
141. reation of a message as a following action on saving a form with a specific status In the case of Following action a message is sent to an e mail address or a fax recipient in the case of a specific triggering status for the form which are selected in the upper part of the page The mes sage content and title are input in the FormBuilder the e mail address or fax number of the address ee are entered in the AdminTool under resources The generation of a fax is only possible if an iAS fax server is installed You can mark in addition the resending of messages through an additional template text which can be entered accordingly This information will then be displayed before the message if the message was previously triggered with the current settings in the AuditTrail of the form This indicates that the result has already been reported e g in the case of an automatic Adverse Event message For form and rule messages that enable the inclusion of form questions in the message changes to the dispatched form values can be marked by configuring this in FormBuilder The values of the cur rent form will then be compared with the last entry in the audit trail Changed values are highlighted in red in messages with HTML formatting In text messages the changes are indicated with changed The note in DataCapture under Sent messages is saved in HTML format It is only pos sible to mark changes for questions from the respective form of the message
142. rmitted between the single field single field per visit and the status report This restriction is necessary because otherwise it would be possible for different report definitions to be simultaneously displayed for a participant in multiple centres with different project versions Statistics seculrial 17 08 2010 20 07 CEST Dipl biol Susanne Schneider Welcome Project Project Study 1 17 08 2010 20 06 52 CEST Statistics Study 1 3 Recruitment statistics v i Title PatientsoverTime Remove Category Rekutieung D Time configuration Month time period MM YYYY label x axis Created evaluated date patient in project Evaluation Cumulative frequency Label x axis Label y axis Chart type bar chat Generation per project e b 2 Patients according Centres Remove gt s Patients according Visits Remove New recruitment statistic of type Patients over time Add Data statistics New data statistic of type Discrete items one visit zi Add Cancel Save and back Save top Fig 36 Configuration of recruitment statistics The statistics can be used to visualise the course of recruitment for a project or the data for individu al form fields To do this there are four different recruitment types and six different data types for discrete or numerical items Select the statistics type which you would like to create and click onto ADD You must
143. rror message If nothing is specified for either rule name or error message a default is used z Sequence position defines the sequence in which rules are checked if several are present but has no influence on the effects All rules and conditions are always checked As rules are equivalent specification of the sequence is irrelevant exception Score rules in this case the score calculation rule should be the first in the sequence The following rule of thumb applies 1 Rules whose fulfilment triggers following actions are evaluated independently of rules which restrict the saving of a form However the actions are only carried out when the form is actually saved either because all saving rules are fulfilled or the result of this check is ignored via the Check data check box 2 Rules which prevent the saving of a form with error messages may all be unfulfilled to enable saving This check if the display is configured can be switched off via the Check data check box the form is then saved with errors in the event of rule violations 3 A logical combination of different conditions for triggering a rule is possible You can link conditions with OR then only one of the conditions must be fulfilled to trigger the rule Alternatively you can link the condition with AND then all of the conditions must be fulfilled A combination of both forms of linking is possible 4 Linking AND and OR conditions can also be used for the calculat
144. s centre option the centre assignment will be automatically changed to single centre The function Patient in multiple centres cannot be used together with the centre specific project version CPV function If necessary the centre assignment configuration will be automatically reset If this function is switched off again even though patients have already been assigned to multiple centres the existing patients will remain assigned to all of their centres and can continue to be ed ited there However in centre oriented reports they will only be listed under their home centre Additional patient ID On entry in secuTrial patients are assigned a pseudonym as identification Pat ID In the case of paper based pseudonymisation this is generated using a secuTrial database randomisation func tion or is generated from the identifying data in the external patient list PIDGenerator via the PID Dispatcher see below A further ID Add ID which must also uniquely identify the patient may also be input by the parti cipants In this case the Add ID can be either Input only for the AdminTool Only for AdminTool After entry this then no longer appears in the DataCapture However it is displayed in the AdminTool and can be used for administration there A Additionally displayed Additional to Pat ID This is displayed in the DataCapture in addition to the Pat ID Displayed alone Instead of Pat ID The
145. sed development version prior to becoming productive Released 3 Productive version Productive The different versions of a project can all be seen in the FormBuilder They are completely listed on the welcome page and are distinguished by colour You may only edit the development version Editability On initially creating a setup you are editing a development version of the project for which no pro ductive version is available yet In this status you can essentially do as you please Forms and items can be created or deleted tables and column names or data types can be changed The FormBuilder ensures that the necessary adaptations are carried out in the data model and database However this also means that any test data which have already been entered are lost or can simply no longer be displayed The consistency of the test data is not guaranteed Previously entered test data for deleted items will also be deleted If you have opened the test Data Capture at the point in time at which the setup is changed in order to test there errors may occur due to the deviating data model The model can be reloaded again in the DataCapture by logging off and on again As soon as a project has been released and a productive version of your project therefore exists the behaviour of the FormBuilder changes To assure that no productive data are lost no further dele tions may be carried out in the structure from then on Further versions c
146. sity Medical Center of the Johannes Gutenberg University Mainz see http www unimedizin mainz de imbei informatik opensource html The URL of the patient list server and the authentication key have to be entered under pseudonymisation in the AdminTool The patient entry form of the Mainzelliste is then integrated in DataCapture and will show up after the login The patient list Mainzelliste offers the option to create study specific pseudonyms comparable to the PIDDispatcher SIC function In order to achieve this a specific idtype has to be included into the communication If no separate idtype is given a default pseudonym type will be generated Therefore and additional selection can be include with the pseudonymisation option external patient list direct to generate study specific pseudonyms per project In order to achieve this the operator of the Mainzelliste has to configure the database scheme of the respective project beforehand as a possible idtype A short help text in the FormBuilder explains this condition The function idtype is only supported by the Mainzelliste like described Extensions of the interface must be coordinated between secuTrial and other patient list software Bundled message dispatch Messages which are generated when processing queries on automatic reset of a SDV status or at empty visits can be defined here These are not dispatched directly but are initially collected and dispatched at the de
147. specify a title wherever possible assign unique names in this case A category can be defined for the statistics in order to summarise several sets of statistics which are related You may e g assign several charts referring to hepatic values to the Hepatic values cat egory Depending on type the category s default setting is Recruitment or Data Depending on the type of statistics you must additionally specify various data regarding the time configuration evaluation evaluated status the visit the item or the range of values For a precise description of the individual data please refer to Product Description II FormEngine The statistics can be optionally generated per project centre or country Select the corresponding category under generation On generation per centre separate statistics files are generated accord ing to the statistics definition for each centre existing in the project In the AdminTool the rights are assigned per statistics definition the relevant centre statistics files are then displayed to each parti cipant according to the role rights for each of his centres In the case of the country statistics the right of access to one contained centre is sufficient to display the statistics For numerical items the value ranges into which the saved data are to be subdivided for evaluation have to be specified You should specify at least two value ranges in order to obtain meaningful stat istics The value ran
148. stion or Item the question has no question text at all this is not checked This may be desired in exceptional cases but may be problematic during the creation and assignment of queries comments Item HTML Here you can input an additional label which enables HTML formatting and permits up to 1000 characters The label is displayed directly after without a gap the normal item label This label is not used for other listings of the item for example query editing or exports If the HTML label is only to be displayed in the form the normal label can be used as the alternative text for all other places In addition the checkbox next to the entry field can be checked so that this label will be hid den in the form itself The online help instructions explain the use of both labels and the configura tion options In the implementation view the HTML formatting of the additional label below the question descrip tion is once again listed separately see 1 in fig 71 Entering the column name makes a distinction possible if multiple items of the question have defined an HTML label A hidden normal item label is listed after the component type see 2 in fig 71 IASHorizontalGroup Radio button C yes 1 C no 0 Fig 71 Documentation of both item labels in the implementation view Unit format The data in the Unit format field are displayed directly behind the input area This field is particularly intended for numerical fields as a si
149. t 4 Type e sa Y Single field Single field per visit Status Query details Icon display Image forms lines per page no automatical participant restriction Automatic export v export every 5 minutes v File name csv Patients e x Style definition of the odd rows lt Pleasechoose gt v Preview rows even rows lt Please choose gt v Preview Fig 35 Editing page for SQL reports with highlighted area for configuring automatic exports When using file names without timestamps or with non unique names any already existing files on the external FTP server will be overwritten without notification The exports on the secuTrial server will nevertheless exist separately for every single transfer The automatic reports are exported to the respective export directory of the secuTrial area setup productive Using very short intervals and many reports will result in a large number of files in a short time On the report editing page of the FormBuilder see fig 34 the general configuration for the auto matic export is displayed in the report list as an additional property under the column title Autom export with yes or no Additional settings Here you can also set the following display settings for each report Show reports of all centres immediately By default every report is initially displayed with only one centre expanded The other centres are closed and can be expanded by clicking on the triangle If this option is s
150. t one parameter of the type greater than less than etc The rule is suitable for medical limit val ues plausibilities and dates which can only lie in a specific numerical range However if the numerical range is limited to a very few options you should consider whether a radio button field or a drop down list would not be a better item type Input impossible These rules define the circumstances under which individual questions must or may not be answered The standard example is the rule Input impossible if This rule always requires the in put of a supplementary condition see below The condition may e g be that another field has been answered with YES The combination of the rule and condition is then e g Input impossible if question 2 has been answered pregnancy YES If pregnancy YES has been specified for question 2 and an entry is made in the item to which the rule Input impossible has been assigned the form is reloaded with an error message on the affected item after saving the form This field is evaluated as completed after saving In contrast the rule nput not required if only affects the completion status as described under 2 but does not trigger an error message in the above example If all of a form s fields have Input not required if rules which are met or nput not required rules and the form is saved without input it is regarded as complete and is displayed accordingly Properties In th
151. t only possib i on 10 Only applicable for female patients Personal Data mnpias1persdata Sex lt gender gt current visit equal value fixed integer female 1 Back Reload Close ale Fig 6 Rule reference display in the pop up window 3 2 Basic operation notes Attention With the exception of the DELETE function no change is accepted without finally clicking onto SAVE This means that all other ways of exiting a page may lead to data loss The programme never warns of this However only the layer in which changes have been made has to be saved the layers above can be skipped if not necessary CANCEL always returns the user to the next highest layer without any save DELETE always leads to the immediate deletion of the relevant element and all contents following one prompt The deletion of elements cannot be undone Editing areas have been set up in the FormBuilder to prevent the occurrence of conflicts when edit ing the same point of the setup These are each entered from the project page Such an area is formed e g from the project configuration page the page for editing the visit plan or each individual form family An area can only be edited by one user at any one time All others can only view these areas all fields are frozen for editing In this case a user is a logged on participant If the same participant therefore logs on twice the FormBuilder regards him as two different users The r
152. tails on which actions the rules are able to trigger please refer to Product Description II FormEn gine Effects of rules Error messages in the DataCapture D 17 08 2010 21 14 CEST Pa ick371 a 2 t Dipl biol Susanne Schneider 03 02 2010 CET Study 1 17 08 2010 21 14 30 CEST Base Examination S e C u r a Centre B Germany F Personal Data Queries Comments Audit Trail Import Print Pers nliche Daten Document No 24 3 Please correct the marked invalid data This person seems to be too young for this study Comment Birth 12 02 2009 dd mm yyyy Birth place xfb Please supply the strongest allergy Allergies C dog C cat C house dust Sex not applicable C female C male Weight Height 200 1 Pregnancy Comment lt Please choose gt z Week lt Please choose gt Please supply the weight Please supply the height Comment IIF Identification Blood sample taken Weight Height BMI E l ll gt Score Hobby Admin Daten importiert 11 11 2009 13 02 31 CET 11 11 2009 12 44 45 CET Cancel Calculate scores Save Save close ent Y Check data Date 17 08 2010 CEST Clinical Investigator Dipl biol Susanne Schneider Project Study 1 17 08 2010 21 14 30 CEST Centre Centre B Country Germany Pat ID ick371 41 visit 03 02 2010 CET Form family Base Examination Form Personal Data Document No 24 3 Fig 78 Error message display in the DataCapture s eCRF The error messages are displayed directl
153. tains the type of table and the project scheme This prefix cannot be changed Table and column names may only have a specific length For tables including the prefix this is 24 characters and 20 characters for columns The Sequence defines precisely this whilst Shown No may be an alphanumerical character which appears on the form before the form name e g A drug In Description a comment on the form can be input and formatted in HTML this is then displayed between the form heading and the form content Query menu comment menu If the display of queries and comments has been configured at the project level with always or never it not possible to configure this option on the form level If scal able has been selected then a configuration can be performed here with the options always nev er and scalable If scalable is selected then another configuration can be performed on the question level Under Form designation a text field in the form can be selected this is displayed in the form over view instead of the normal form name This function is particularly helpful for adverse event forms in order to display the type of AE input in the form in a text field e g as Type of event on the form overview Under Form thumbnail an image item can be selected for image form family forms in the form overview this is displayed as a thumbnail on the large form icon Take values from previous visit Values wh
154. ted for each statistics type Depending on statistics type up to five different chart types are available for selection whereby the various bar and pie charts each offer a 3D view The type which you use is dependent only on which type depicts the desired information most clearly For details on the possible types please refer to Product Description Il FormEngine If you no longer wish to have the statistics in the project they can be removed from the project using the Remove button For deletion to take effect however it must additionally be confirmed by press ing the Save or the Save AND Back button Clicking onto the Save or the Save AND Back button accepts all changes These are discarded with CANCEL All changes on the statistics editing page i e the creation of new statistics the editing of existing statistics and also the removal of statistics are only effectively accepted permanently by saving the page Patient letter 17 08 2010 20 13 CEST Centre B Dipl biol Susanne Schneider Germany Secu ria Study 1 17 08 2010 20 11 53 CEST pxe146 Edit Visit plan Patientfile New patient Select gt Visit plan Adverse Event Patient status Images 1 visit 2 visit Next visit Planned visits 02 01 00 03 01 00 Data entry Base Examination Print letter Fig 38 View of a form overview in the DataCapture The patient letter is shown via the PRINT LETTER button beneath each visit This button is displayed to each
155. tfield into a 60 textfeld For items with reset option it can also be configured if and on which position the option will be dis played If the scalable Missing Values funktion MV has been configured for the project you can choose at the item level whether MV will be used for the respective item see Fig 70 For item types without a user entry a configuration of the function is not possible The item types are the following Score field Score date field all intervals Layout dummy Random field In UnitGroups the MV configuration of the number entry field automatically also applies for the unit popup and DB dummy Setting the MV status for the number field also automatically sets all MV statuses for these items For items with a group of labels radio buttons popups radio button and checkbox matrix a new level for creating and editing the labels can be reached via the link Edit group of labels see Layer Group of labels The Displayed order defines the sequence in which the items are presented in the FormBuilder and in the DataCapture The Displayed No has no influence on this it exclusively follows your number ing system It may remain empty Note Item Here you can input the text for the item This is optional because the text for the upper ques tion may also be present as the question text under certain circumstances as mentioned under Question If you do not input a text for either Que
156. the map ping Certain item types must always be mapped for importing Pop up radio button Assignment of the external to the individual internal options Date fields Selection of the display format in the import A lASUnitGroups Selection of the import unit i e the unit in which the imported value has been measured Check boxes Specification of the external value for yes clicked and no not clicked items from subforms Mapping entries can also be defined for items from subforms In addition to the subform item the repetition group of the main form must also be selected as the internal variable to be applied for the mapping This is necessary for clear assignment if the same subform is used multiple times in a main form Instructions 1 Enter the external variable in the first column as it will be specified in the file to be uploaded 2 Search for the corresponding internal variables already predefined in the form 3 Define the options accordingly for the individual types Special rules Mass imports can only be carried out for casenodes and visit forms Only individual imports can be defined for adverse events and image forms As import formats are not linked to form contents these can be easily edited or deleted without influ encing the form contents already input in the DataCapture in any way The internal variables can only ever be assigned once otherwise they would overwrite the values duri
157. tion group and are highlighted in colour In addition questions and items are displayed in the same way as questions and items in the main form The subform is summarised by the highlighted colour of the first column before the sub form questions and the final double line beneath the last subform question Messages which were configured for a rule are listed below the form description For rule descrip tions the messages are referenced by corresponding number If no label is displayed in the form at all because the normal item label is hidden and no HTML label is specified than the hidden label will be included in the data record table in italic font This presenta tion is similar to that of the unique question label if no question label is displayed in the form itself Items The item label can be configured as hidden in form display e g to display only the alternative HTML label If no label is displayed in the form at all because the item label is hidden and no HTML label is spe cified than the hidden label will be included in the data record table in italic font This presentation is similar to that of the unique question label if no question label is displayed in the form itself Lookup tables All lookup tables created in a project are documented in a separate table sheet The general entries are listed in the upper area and all other entries are listed below Project configuration A seculrial 17 08 2010 19 59 CEST Dipl bio
158. to a form in the same project can be copied Manually checking the copied set of rules is recommended under all circumstances Organize questions By clicking ORGANIZE QUESTIONS will get you to the subpage Organize questions You can edit here the order of the questions and items as well as move individual items from one question to another Included questions Displayed order Shown no Question Type Hidden Delete from database gt fo 7 StandardGroup ASStandardGroup o NEN AlternateStandardGroup ASAlternateStandardGroup EM Eu Headline lASHeadline pfo NEN HorizontalGroup IASHorizontalGroup o NEN RepetitionGroup ASRepetitionGroup eo 1 Horizontale Radiobutton Matrix ASHorizRBMatrix O organize questions Copy question from New question Fig 64 Button for organizing questions and items of a form on the form editing page There are some restrictions which do not permit the movement of items to or from a question No items can be moved into question components in which the item type is determined by the question component e g radio button matrix ASCatalogGroup In other components e g MultipleSelec tion no items can be moved into or out of these components because their function depends on the relationship of the contained items These limitations are controlled by either preventing the removal of items or by not listing the question as a target in the drop down lists It is possibl
159. tructure and rules defined for this form Above the lower button bar is a list of all answer options hidden in drop down lists The implementation view contains one or more clickable references for each question Clicking onto one of these opens the entry on the question rule etc whose link you have clicked in the Form Builder main window This therefore takes you very quickly to the desired element in the form without first navigating through the entire FormBuilder hierarchy In addition special or incomplete rule conditions will be marked in the implementation view These mean Note Note Rule conditions from another form or visit Incomplete rule conditions e g if rules can t be be copied completely because their format doesn t correspond with the target item format Marks a rule s precondition Annotated CRF view In this view the used secuTrial component types the unique question texts and the database column names of the items are displayed Rules and rule conditions are not dis played Search display The search display depicts the layout of the form search in the ExportSearchTool Using the RELOAD button displays the changes which you have carried out in the form in the mean time in the form view without closing the popup window The page can be printed out using the PRINT button on the right side of the footer In the preview win dow of a form under the menu bar at the top you see a coloured bar which sig
160. ts the check box must be set here At least one CSV parser must then be defined If the import format for mass import is permitted mass import in the DataCapture is possible from the welcome page using the IMPORT button Parser At least one explicit parser which is able to process a specific data format must be specified for each import format Only parsers which have already been implemented can be selected here At present the user can choose between the listing parser default and the CSV parser The listing parser is able to process the following files Each value pair variable value is located individually in a line Variable names contain no blanks text limiters separating characters or assignment characters Blank lines or lines which contain no equals characters allocation character are ignored If a text delimiter has been defined values within the text delimiters are regarded as text values Blanks within text delimiters are not then interpreted as separating or end characters Aline break within a text value represents an error Text values must not contain any text delimiters Separating or allocation characters within a text are ignored The CSV parser processes the following files Excel file as csv The variables are specified in the first line and the values as of the second line Only one patient may be defined per line On individual import the CSV parser on
161. und value must be unique i e it must refer to only one form If forms from several visits or patients in which the corresponding value occurs are found this represents an error and import cannot be carried out Only number or text fields are possible as data record identifiers As in the case of mapping you specify an external variable name which can take any form for the internal variable The selected variable cannot addition ally be used for import Visits Choose on import If you click on this option when importing data in DataCapture the visits which are to be imported will be directly selected Specify in import file If you click on this option the visits which are to be imported must already be entered in the import file in an additional column You can choose from 3 different options for naming the visits Date of the visits name of the visits or number of the visits A Additionally you must enter a column heading which must be identical with the one in the im ported file Numerical format Here you can specify whether the numerical values in the file to be uploaded are available in the English or German format The German numerical format is set as default decimal point is specified as a comma Text comparisons By clicking on you can specify whether you would like to ignore higher and lower case letters in the variables or option values Mass import If the import format is to be used for mass impor
162. xport catalogue Update catalogue b Catalogue used here in 2 forms Save and back top Fig 13 Selection of the exported catalog file Modify catalogs You have the option of changing an existing generic catalog to which the release rule only this customer applies in the current project To do this a new catalog file is imported the previous cur rent catalog is archived and the catalog references are adapted accordingly in the development pro jects Modifying immediately takes effect in the development project version To use the modified catalog version in the productive area the project must again be released and then migrated to productive mode The changed catalog values only take effect in the DataCapture if the form is saved again after re loading The corresponding catalog version is displayed in the form and in the AuditTrail To modify an existing catalog click on to the MobiFv CATALOG button on the catalog editing page As soon as the new catalog file has been uploaded you are requested to reassign the catalog layers and information Mandatory fields are marked with a red asterisk DET seculrial te 12 08 2010 19 15 CEST Participant Hobby Admin Welcome gt Catalog list Modify catalog Please assign all new imported layers and columns right to all existing layers and columns left of the catalog Catalog name MedDRA Test Layer 1 WarenGruppe lt Please choose gt v KapitelNummer lt Please choos
163. xtKatal gnur setup Catalog 3 13 1 customer 19 05 2010 16 20 CEST Hobby Admin Michels Test Katalog Catalog 3 13 2P customer04 12 2009 13 00 CET Hobby Admin TextKatalog Catalog 3 13 O custorner04 12 2009 15 33 CET Hobby Admin Delete TextKatalog Catalog 3 118 O customer09 12 2009 18 46 CET Hobby Admin Delete AQ Catalog 3 13 O customer 19 05 2010 15 12 CEST Hobby Admin Delete D Catalog 3 13 O customer19 05 2010 15 13 CEST Hobby Admin Delete Create new catalog Cancel top Fig 9 Overview of all available catalogs general and customer specific The fold out catalog in the upper part shows the archived catalog versions for description see below Importing generic catalogs Generic catalogs can be autonomously generated by uploading a catalog csv file and can then be used in all projects for the same customer These catalogs must be available in a specific format which can be found in the Annex If you click onto the NEW CATALOG button you can upload a new catalog a sec ulr d l Date 17 08 2010 19 42 CEST Participant Dipl biol Susanne Schneider Logout Welcome Catalog list Import catalog e Import a new catalog You can import a new catalog here or modify an existing one The catalog file has to be a CSV file as saved by Excel for example You also have to specify the file encoding here The file has to use a semicolon as the value separator and optional quotes around the values a
164. y above the relevant item Violations against rules which have been created in the FormBuilder are identified via error mes sages in the DataCapture As described in the DataCapture user manual a form containing data which violate rules is reloaded after sending click onto SAVE A red bar with a general error mes sage e g Please check the marked entries now appears beneath the form title An error message red text which explains the error in plain text now appears directly above the item with a rule con flict This error message must be input for each rule created in the FormBuilder see below It is very important for usage that this text describes the error or conflict precisely and understandably Completion status The set of rules which is created in the FormBuilder interacts with the form completion status check empty partly filled or completely filled The completion status itself is determined via a check which is not directly configurable In the FormBuilder the circuitous route of rules can be used to in fluence the completion status of a form after data input During the check which is carried out during the saving process all fields items are regarded as mandatory fields as standard l e if a question is not answered the form is regarded as incomplete However this only occurs in the form status and is not regarded as a rule violation The completion check may however be displayed if this has been configured ce
165. y as follows Pre selection AE form s Create new AE SAE AE AE SAE Date SAE SAE form s Converting via rules AE form s jk 6 SAE rule Create new AE SAE Date AE SAE form s Fig 33 Procedure and form compilation for adverse and serious adverse events depending on the project configuration It must be noted that on preselection of AE or SAE a new event always has to be created to create a serious adverse event whilst an adverse event is transformed into a serious adverse event in the case of the rule decision i e no new event has to be created for this As a further option you can set whether adverse events always have to be created chronologically or whether the sequence on creation of a new event is arbitrary You can select if the adverse event date is preset with the current date or whether the date entry page is skipped entirely The preset date is then the current date but it is no longer displayed in the overview Follow up examinations in which the event forms can be filled in again can be created for adverse events If the creation of follow up examinations is not desired the Close Adverse Event rule can be set to any mandatory field in the first AE form On meeting the rule condition no further follow on examina tions can be created Completion of the event is also necessary if review B is to be carried out on the form Reports amp seculrial 17 08 2010 20 06 CEST Dipl biol
166. ze unit can be displayed here e g m Database column Here a name must be entered for the database when the form is saved As in the database table this should also reflect the meaning of the item in a relatively self explanatory manner In this case the column name is subject to the same constraints as the database table names see Annex If this involves a print form without database table a Unique name within the form must be input in stead of the database column This is required to internally process the inputs For text and image items in a DDE form the desired comparison option can be set for the DDE func tion detailed information about this can be found in Product Description II Hide in DataCapture Individual items may also be hidden just as forms and questions If an item is no longer to be displayed in the form in the DataCapture activate the option Hide in the DataCap ture The item is now no longer visible in the DataCapture The item is also no longer included on re calculation of the completion or SDV status of a form In the implementation view the item is shown with a red dashed border CDISC ODM export annotations Specifying the variables for SDTM annotation was also possible in the previous secuTrial version as SDSVarName with a maximum length of 8 letters no special characters or numbers A selec tion enabling the variable to be selected via predefined lists in the same manner as for the SDTM domain h

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