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1. Hard errors are implemented on the E forms gt Only correct data can be saved The forms have to be entered in the right order E1 gt EZ Ede In case you have created a new patient by mistake or you have realized only at the time point of registration that the patient is ineligible please contact the SAKK CC 11 Clinical Data Management Patient registration 1 Click on new patient MyAccount Messages Import Reports Select a project choose the trial New pation You can either create a pew patien or take an existing gatient over into a paproject Select a project lt Please choose gt Select a centre your site if not already preselected 12 Clinical Data Management 11 7 2013 Patient registration For the entry date enter the date of the planned treatment start You can either create a mew patient or take an existing patent over into a partproject Select a project SAKK 08 11 05 09 2012 07 24 08 CESTI Select a contre Spitalxy 0811 The system will generate a unique patient number The entry date will be used as base for the visit plan Form E1 will be opened automatically 13 Clinical Data Management Patient registration 6 Note the unique number in the screening enrollment and identification list 4 ENVIRONMENT ecuTial test SETUP gt The screening enrollment and identification list is the only link between the patient s identity an
2. Unknown day and month dd mm If only year is known fill in 30 06 as estimated day and month and add the comment estimated day and month into the comment field as described for numeric values 41 Clinical Data Management Unknown data not values dates gt For text fields enter one of the three reasons into the field Specify toxicity other here gt gt For dropdown lists with none of the three reasons as an option add a comment into the comment field as described for numeric values Specify toxicity other here 42 Clinical Data Management 21 43 44 11 7 2013 Warnings In case of inconsistent or missing data a warning message is displayed by the item when clicking save savetclose The data are not saved yet TR TRANSLATIONAL RESEARCH URINARY STEROID METABOLITES Please check marked entries before saving INSTRUCTIONS During pretreatment evaluations between day 14 and day 0 before any drug administration 12 weeks after treatment start day 1 of cycle 4 Sampling date 05 09 2012 dd mmyyyy Input required None co Input required ACEWVARB Ol Ca antagonist SE Clinical Data Management Warnings Read all warning messages and check your data Confirm the data by clicking save save close again your data will be saved except for form family E see patient registration Saved forms containing missing or incorrect
3. 1 0 Patient overview Accrual 2 Enter the patient number into the Select field press enter 35 Clinical Data Management Access to forms Click on the form family icon in the visit plan gt The form opens immediately if the form family consists of only one form gt f the form family consits of two or more forms an overview appears at the bottom of the visit plan Click the form icon to open the form a 36 Clinical Data Management 18 11 7 2013 Saving data 1 2 Cancel 1 Click save for started but not completed data entry or for E buffering data 2 Click save close entry for completed forms gt E forms have to be completed with Save close entry see patient registration gt Forms closed with Save close entry by mistake can be edited again by clicking Reopen data entry gt Closing data entry is a trigger for monitors to perform SDV After SDV data can not be edited anymore unless a query is asked 37 Clinical Data Management Unknown data gt Fill in data for each field on each CRF gt If this should not be possible there are three reasons why data cannot be filled in not done not applicable unknown gt Some forms question already have a choice to check one of the three reasons leave the field s empty and tick the reason Total bilirubin ULN Date ot done pmol L pmol L dd mm yyyy gt Wherever none of the three a
4. Visit 7 t 66 Clinical Data Management 33 11 7 2013 Finding queries visit plan Visit plan gt Find queries via symbols a Visit plan Adverse Events Other forms Registration Pretreatment Visit 15d aftervi Visit 3 Planned visits 08 08 12 08 08 12 23 08 12 05 09 12 E_Eligibility 9 A_Baseline B_Visit L_Lab T_TumorAssessmen t QL_QualityOfLife C_EndofTreatment F_FollowUp TR Translational Research 67 Clinical Data Management Answer queries Check query report or patient overview click on patient number or go directly to the patient Check form status open forms with the symbol for asked queries 2 Check for questions marked with a red on the left side ULN Date 10 L 68 Clinical Data Management 34 Answer queries 4 a click query choose the field and answer the query save or Query Serum creatinine 25 Wegmann 14 03 2012 20 13 CET Value missing Please enter value or prowde reason Please enter your answer here ULN Date b fill in the answer directly into the field Serum creatinine ULN 22 10 L gt Answered queries are marked with a little red at the left of the question row 69 Clinical Data Management Answer queries 5 Provide a reason for the modification at the bottom of the form and save modification Reason for modification query Cancel SETS gt Forms with answered
5. by mistake you can always go back to the original dropdown list via Selection If the entry was not already listed fill in the new entry into the text field and click on the grey arrow Buchli Michael Presse choose gt v 4 The new entry will be added to the list Report wrongly added entries to the SAKK CC 46 Clinical Data Management A SAKK 11 7 2013 23 Repetition groups gt Elements with an indented header and buttons delete more can be repeated several times by clicking more A2 BASELINE HISTORY Are there any clinically significant diseases rFiNo Yes specify below other than prostate cancer Disease Specify other lt Please choose gt 2 amp Disease lt Please choose gt Disease lt Please choose gt 47 Clinical Data Management Catalogues gt Inthe AE form a catalogue with the CTCAE v4 0 is implemented see AE reporting 1 ADVERSE EVENT System organ class SOC If other specify below Grade Relation to treatment lt Pleasechoose gt v lt Pleasechoose gt v Still ongoing at 30 days after treatment or prior to next treatment _ End date not applicable Cancel Save Save close entry V Check data Date 06 09 2012 CEST Developer Miriam Wegmann Project SAKK 08 11 05 09 2012 07 24 08 CEST Centre Spitatxy 0811 Country Pat ID gis494 UPN 0811_027 1 AE Adverse Event 06 09 2012 CEST Form fam
6. If you are a registered user please enter your user ID and password u ng Cab gt Pop up blockers EEE REN have to be switched off BE gt Password has to G be changed at the first login Please be aware that by logging in you are taking responsibility for the actions undertaken login and or password to any other person as their actions will H Login Change password Clinical Data Management 7 gt Be aware that on the following slides all background colors are green since they are print screens form our test environment gt The color of the productive online EDC environment will be blue Clinical Data Management Welcome Page 8 Clinical Data Management 1 Timer gt gt 2 User information 3 Welcome text 4 User Manuals 5 Taskbar gt gt A SAKK 11 7 2013 11 7 2013 Welcome Page gt Timer DataCapture 4 3 0 7 SAKKKTime left 38 4 After 40 minutes without any active use the system will automatically log you out gt Taskbar 1 Go to reports and statistics 2 Register a new patient 3 Enter patient number to select a patient 4 Log out to prevent unauthorized access 9 Clinical Data Management Patient registration 10 Clinical Data Management 11 7 2013 Patient registration Patients have to be registered online by the site staff only in case of system breakdown it is allowed to register the patient by faxing the E form
7. lt All gt lt All gt lt All gt v lt All gt v lt All gt M 248 fse702 Spitalxy 0811 Wegmann 08 02 12 E5 Laboratory Values Absolute neutrophil count ANC fse702 Spitalxy 0811 Wegmann 08 02 12 E4 Physical Examination WHO performance status wsb520 Spitalxy 0811 Wegmann 28 06 12 28 06 12 E1 Information on Patient Registration Did the patient agree that urine samples and tissue samples are being used in scientific studies for further research wsb520 Spitalxy 0811 Wegmann 28 06 12 E1 Information on Patient Registration Did the patient agree that samples data may be used in as of yet undetermined biomedical research projects without being informed in specific instances and providing consent wsb520 Spitalxy 0811 Wegmann 28 06 12 28 06 12 E2 Inclusion Criteria gt Summary of open answered and resolved queries open query answered query v solved query x recalled queries gt The report can be sorted by clicking on the column name gt The report can be filtered with the dropdown items Clinical Data Management Accrual Accrual L000 Spitalxy 0811 1Y SS Clinical Data Management 38 Guidelines Training amp Support 77 Clinical Data Management Guidelines gt This trial specific manual can be downloaded from download area of the welcome page see access to secuTrial gt A General user manual can be found in the members section on the sakk website under gu
8. an email confirming patient registration 17 Clinical Data Management Form Overview 18 Clinical Data Management 20 Form Overview gt Role and name Centre gt Site Patient gt Patient number Rando No if applicable Welcome gt back to welcome page Visitplan Adverse Events Other forms etc gt gt Clinical Data Management Form Overview Visit plan gt Forms part ofthe visit plan Clinical Data Management 11 7 2013 10 11 7 2013 Form Overview Adverse Events TE ENVIRONMENT SAKK seTUP lar Adverse Events th gt Reporting of AEs 21 Clinical Data Management Form Overview Other forms etc TE ENVIRONMENT SAKK seTUP SAKK 08 05 09 2012 07 24 08 CEST gis494 gt Forms not part of the visit plan 22 Clinical Data Management Visit plan 23 Clinical Data Management Visit plan Stick to the excel scheduler m Date of planned visits are calculated on base of the entry date when creating a new patient 24 Clinical Data Management 11 7 2013 12 Visit plan TR SAKK serur Patient on on Patent Registration 25 Clinical Data Management 11 7 2013 Planned visits Add scheduled or unscheduled visits Form families Available forms at different visits Forms of family E Eligibility Edit visit plan gt gt Changing dates of planned visits Click Edit visit plan Cait visit ian plan DPatientfile N
9. 11 7 2013 A SAKK Schweizerische Arbeitsgemeinschaft f r Klinische Krebsforschung Groupe Suisse de Recherche Clinique sur le Cance Swiss Group for Clinical Cancer Research Gruppo Svizzero di Ricerca Clinica sul Cancre The Swiss Oncology Researe Overview Access to secuTrial gt gt 3 Patient registration gt gt 10 Form Overview gt gt 18 Visit plan gt gt 23 Data Entry gt gt 33 AE reporting gt gt 51 Query Management gt gt 63 Reports and Statistics gt gt 71 Guidelines Training amp Support gt gt 77 2 Clinical Data Management 11 7 2013 Access to secu Trial 3 Clinical Data Management Access to secu Trial m One login for all secuTrial trials Rights to access the data of a particular trial have to be allocated by the clinical data manager at the SAKK CC m Site staff can only access data of the own site How to get access to secu Irial gt Send authorization list to the SAKK CC gt Trial coordinator forwards request the clinical data management gt Login details User ID and password will be sent to site staff within 2 working days 4 Clinical Data Management f SAKK Access to secuTrial gt gt www sakk ch edc A SAKK The Swiss Oncology Research Network Welcome to the SAKK EDC trials Please select the trial from the list below that you would like to enter data for You will then be forwarded to the appropriate EDC system login page Tri
10. 12 dd mmyyyy 2 Moderate v 1 Unrelated X 02 09 2012 ddmmyyyy Delete Start date Grade Relation to treatment End date 03 09 2012 ddmmyyyy 1 Mild 1 Unrelated v 05 09 2012 dd mmyyyy gt The green color indicates the AE is complete Visit plan Adverse Events Other forms 1 Fever T New Adverse Event 60 Clinical Data Management 30 11 7 2013 AE reporting end of treatment 9 C AE still ongoing 30 days after treatment Leave the end date empty and tick the checkbox for still ongoing Save close entry and go back to form overview Start date Grade 01 09 2012 ddmmyyyy 2 Moderate Delete o Moe Still ongoing at 30 days after treatment or prior to next treatment V End date not applicable gt The form status indicates that AE reporting is completed Adverse Events Other forms 61 Clinical Data Management AE reporting unknown dates If the exact dates for start and or end date are not known enter the following dates gt Start date fill in the date one day after the last visit where the AE did not yet appear where grade did not yet change gt End date fill in the date one day before the next visit where the AE did no longer appear where the grade did change 62 Clinical Data Management 31 Query Management 63 Clinical Data Management Finding queries Report gt New patient See gt 1 Click on Reports choose Query rep
11. CTCAE_4_03_2010 06 14_valid p CTCAE v4 03 National Cancer Institute Blood and hymphatc system disorders b CTCAE v4 03 National Cancer Institute Cardiac disorders gt Alternatively the right term can be manually chosen by clicking on the arrows left to the SOC terms Nabonal Cancer institute Blood and tynphatic system disorders National Cancer institute Cardiac disorders National Cancer institute Congenital famiial and genetic disorders National Cancer institute Ear and labynnth disorders National Cancer Institute Endocrine disorders National Cancer institute Eye disorders National Cancer institute Gastrointestinal disorders National Cancer institute General disorders and administration site conditions National Cancer Institute Hepatobiliary disorders 55 Clinical Data Management AE reporting 6 Click on the term CTCAE_4_03_2010 06 14_valid Naona Blood and ymohat Cancer system disorders Insttune Thrombotic A disorder characterized by the presence of microangiopathec hemolytic thrombocytopenic anemia thrombocytopenic purpura fever renal abnormalities and purpura Nora Gastromesina Cancer Asorders insttute A disorder characterized by afaenenation of the smal and large intestines Severe or persistent abdominal pain fever ileus peritoneal signs A disorder characterized by niammation of the cecum Symptomatic g abdominal pain fever change in Dowel habits with ileus peritoneal signs A disorder chara
12. al Number SAKK 01 10 SAKK 08 11 SAKK 09 10 SAKK 16 08 SAKK 17 04 SAKK 19 09 SAKK 24 09 SAKK 35 10 SAKK 39 10 SAKK 40 04 SAKK 41 06 SAKK 41 08 SAKK 41 10 SAKK 56 07 SAKK 75 08 SAKK 77 08 Project Group Urogenital Cancers Urogenital Cancers Urogenital Cancers Lung Cancers Lung Cancers Lung Cancers Breast Cancers Lymphomas Lymphomas Gastrointestinal Cancers Gastrointestinal Cancers Gastrointestinal Cancers Gastrointestinal Cancers Gastrointestinal Cancers Gastrointestinal Cancers Gastrointestinal Cancers EDC System secuTrial secuTrial sinatras only registration sinatras sinatras only registration sinatras sinatras sinatras only registration secuTrial paper trial sinatras only registration sinatras only registration sinatras only registration secuTrial sinatras only registration sinatras only registration sinatras 11 7 2013 SAKK Coordinating Center Effingerstr 40 3008 Bern Phone 41 31 389 91 91 Fax 41 31 389 92 00 www sakk ch Clinical Data Management Access to secuTrial sA SAKK Schweizerische Arbeitsgemeinschaft f r Klinische Krebsforschung Groupe Suisse de Recherche Clinique sur le Cancer Swiss Group for Clinical Cancer Research Gruppo Svizzero di Ricerca Clinica sul Cancro The Swiss Oncology Research Network SAKK EDC Trials Registering new patients filling in CRFs SAKK This area is non public and accessible for registered participants only
13. bk ch Loge Change pusmsord gt Make sure you are in the Test Environment green logo with red writing test environment green background an forms 79 Clinical Data Management Training You can log into a training platform with test data with User ID trainSite and password training12 You are logged into a test database The trial set up for training is fictional and consists of the most commonly used forms Be aware that changes or interruptions are possible and test data can be overwritten or deleted 80 Clinical Data Management 40 11 7 2013 Support Contact the trial coordinator at the SAKK CC in case of gt wrong warnings gt needed support gt needed additional training gt login failure gt wrongly entered patient Your request will be processed by the trial coordinator or forwarded to the clinical data management team 81 Clinical Data Management 41
14. bove reasons Is provided follow the following guideline for unknown data gt gt 38 Clinical Data Management 19 11 7 2013 Unknown data numeric values 1 Leave the field empty and click on comment Start date End date Pose per da Is there a dose deviation Specify toxicitylother here lo dd mm yyyy io dd mm yyyy g lt Please choose gt X 2 Choose the appropriate field and write one of the three reasons as comment e g unknown click save Comment _null 1 gt Start date gt End date Dose per day Please enter your comment unknown Cancel Save Is there a dose deviation Specify toxicity other here 39 Clinical Data Management Unknown data numeric values 3 Go back to form Notice The comment has been added to the data Back to comments gt Commented fields are marked with a little red c at the left of the question row C sta date End date Dose per day Is there a dose deviation Specify toxicity other here L dd mm yyyy 4 L dd mm yyyy mg lt Please choose gt gt Commented forms are marked with a c e 40 Clinical Data Management 20 11 7 2013 Unknown data dates dd mm yyyy gt Unknown day dd If only month and year is known fill in 15 as an estimated day and add the comment estimated day into the comment field as described for numeric values
15. cterized by a sensation of cold that often marks a physiologic response to sweating after a fever A disorder characterized by elevation of the body s temperature above 10016948 the upper limit of normal Flu Ihe symptoms A disorder characterized by a group of symptoms similar to those 1001679 observed in patients with the flun includes fever chills body aches malaise loss of appetite and dry cough Alerg reaction A disorder charactenzed by an adverse local or general response from anne In an aeran 56 Clinical Data Management 28 11 7 2013 AE reporting 7 The SOC and the term will be entered automatically into the AE form gt Incase of other do not forget to specify 1 ADVERSE EVENT aan System organ class SOC General disorders and administration site conditions Comment Fever If other specify below Grade Relation to treatment lt Pleasechoose gt v lt Pleasechoose gt v Still ongoing at 30 days after treatment or prior to next treatment Comment C End date not applicable Cancel Save Save close entry V Check data Date 06 09 2012 CEST Developer Miriam Wegmann Project SAKK 08 11 05 09 2012 07 24 08 CEST Centre Spitaixy 0811 Country Pat ID gls494 UPN 0811_027 1 AE Adverse Event 06 09 2012 CEST Form family Adverse Events Form AE Adverse Event 57 Clinical Data Management 4 SAKK AE reporting 8 Report start date grade and relation to
16. d the patient number gt Retrospective assignment of patients to a patient number is not possible 14 Clinical Data Management 11 7 2013 Patient registration 7 Enter form E1 and click Save close entry print Cancel Save Print e Save close entry print gt gt A print window will pop up automatically pop up blocker has to be switched off if no pop up window shows press ctrl p to print gt Do not use the Save print button 15 Clinical Data Management Patient registration 8 Print form E1 fill in date and signature gt only the treating investigator is allowed to sign the form INSTRUCTIONS This form has to be printed and signed by the treating investigator Please send the signed form by mail or fax within a month after registration to SAKK Coordinating Center Effingerstrasse 40 CH 3008 Bern Fax 41 31 389 92 00 9 Send form E1 to SAKK CC by fax 41 31 389 92 00 or mail within one month after registration 16 Clinical Data Management 11 7 2013 Patient registration 10 Open the next form by clicking continue Notice The entered data has been saved Edit next form E2 Inclusion Criteria Back to form Back to form overview Continue gt Ifthe next form is not presented on the screen make sure you clicked save close on the previous form 11 Complete all E forms with save close entry 12 You will receive
17. data are marked with a grey exclamation mark In case of incorrect warnings contact the SAKK CC Clinical Data Management 22 Form Symbols Edit Visit plan Patientfile New patient Select gt You can find an overview of the form symbols by clicking help on the visit plan screen Hep Form overview compa db table not stored empty partially filled completely filled data entry complete standard form Adverse Event form Serious Adverse Event form These forms will not be stored in the database No data has been entered yet The form has been saved empty In the form family at least one form has been stored empty Atleast some data has been entered but not all mandatory fields have been filled All mandatory fields have been filled The data entry is finished This status does not display the underlying completion status Used for the capture of normal data For capturing data during the workflow of Adverse Events For capturing data during the handling of Serious Adverse Events Sp SBD aan validation The rule validation of this form finished with problems warning error comment At least one comment has been posted SW SDD DBD 45 Clinical Data Management Extendable dropdown lists Dropdown lists with a button Others underneath are extendable 1 The needed entry is not listed in the dropdown list click Others lt Please choose gt v If you clicked Others
18. ew patient Select gt Change date and click Preview The dates of subsequent visits will be shifted Entry date Registration Pretreatment Visit Visit 1 15d after vi Visit 2 15d after v2 Visit 3 Visit 4 26 Clinical Data Management Edit Visit plan After date change af subsequent visits will be shifted accordingly as long as the dates has not been changed for theaselves The last scheduled or the last unscheduled visit of the same type without data entry can be deleted 05 09 2012 CEST 05 09 2012 CEST 05 09 2012 CEST 05 09 2012 CEST 19 09 2012 CEST 03 10 2012 CEST 17 10 2012 CEST 31 10 2012 CET 28 11 2012 CET 2012 2012 2012 2012 03 10 2012 17 10 2012 31 10 2012 28 11 2012 dd mmyyyy CETICEST dd mmyyyy CETICEST dd mmyyyy CET CEST dd mm yyyy CETICEST men Od mm yyyy CETICEST dd mmyyyy CETICEST dd mmyyyy CETICEST dd mmyyyy DETICEST Cancel Reset 13 11 7 2013 Changing dates of planned visits 3 Enter a reason for modification and confirm by clicking Save Edit Visit plan After date change all subsequent visits will be shifted accordingly as long as the dates has not been changed for theirselves The last scheduled or the last unscheduled visit ofthe same type without data entry can be deleted Current visit plan New visit Entry date 05 09 2012 CEST Entry date 05 09 2012 CEST Registration 05 09 2012 CEST Re
19. gistration 05 09 2012 CEST Pretreatment Visit 05 09 2012 CEST Pretreatment Visit 05 09 2012 CEST Visit 1 05 09 2012 CEST isi 95769 2012 CEST 15d after v1 19 09 2012 CEST 17 09 2012 CEST Visit 2 03 10 2012 CES Visit 2 01 10 2012 CEST 15d after v2 17 10 2012 CES 15d after v2 15 10 2012 CEST Visit 3 31 10 2012 CET Visit 3 29 10 2012 CET Visit 4 28 11 2012 CET Visit 4 26 11 2012 CET Reason for modification shifted due to holidays Cancel Back Save 27 Clinical Data Management Deleting pre defined visits Click Edit visit plan Edit visit plan Patientfile New patient Seet 2 Incase the patient did go off study before completing all pre defined visits you can delete empty visits Edit Visit plan After date change af subsequent visits will be shifted accordingly as long as the dates has not been changed for theirselves The last scheduled or the last unscheduled visit of the same type without data entry can be deleted Entry date 05 09 2012 CEST 05 09 2012 ddmmyyyy CETICEST Registration 05 09 2012 CEST 09 2012 dd mmyyyy CETICEST Pretreatment Visit 05 09 2012 CEST 5 09 2012 dd mmyyyy CETICEST Visit 1 05 09 2012 CEST 09 2012 ddmmyyyy CETICEST 15d after vi 19 09 2012 CEST 9 09 2012 dd mmyyyy CETICEST Visit 2 03 10 2012 CEST 3 2012 dd mmyyyy CETICEST 15d after v2 17 10 2012 CEST 2012 dd mmyyyy CETICEST Visit 3 31 10 2012 CET 3 z 2012 dd mmyy
20. idelines amp documents gt Where applicable use the Help buttons on the right side of the questions for data entry guidelines INSTRUCTIONS Evaluate the consumption of analgesics during the last 24 hours before the visit on day 1 of cycle 2 7 Enlist the analgesics according to the WHO analgesics ladder and report the highest code for further specifications click the button help WHO analgesics pain ladder code lt Please choose gt v Not applicable trial treatment duration is gt 6 on months HELP WHO analgesics ladder Code Type Examples 0 78 Clinical Data Management 11 7 2013 39 11 7 2013 Training 1 Open the following link https secutrialdev sakk ch apps WebObijects ST21 setup DataCapture woa wa choose customer SAKKD iy ENVIRONMENT PA SAKK SAKK IT test environment SETUP SAKK EDC Trials Registering new patients filling in CRFS bes area is rot fot pobiec bona ts is erty Bee Pi tp regpatered SAKK members E you ate a mgpstered user please ertor user and pasowerd n the respecte felts Yen you k fo the feat hese you well be required fo change yout paxsworl Al subsequert logne fhe passen can de changed manuaty by uang the button Change passwoed Please be aware that by logging in you are toting resposcibety for re actions undertaken on Sys uate under pour narte Newer give your logh astio parewword Lo aty other person as thee actions wil be atinteted da you for sews check waw co
21. ily Adverse Events Form AE Adverse Event 48 Clinical Data Management 11 7 2013 24 Scores gt Scores are automatically calculated data Scores are calculated when clicking on Score or when saving saving closing the form Estimated creatinine clearance Seer 156 mL min gt 40 mL min gt Scores are often needed for checks warnings Those sections are marked with the title Calculated Values they are for internal use only CALCULATED VALUES INSTRUCTIONS This section only contains calculation steps No information can be filled in Age years Wiser 53 years Age days Msa 19240 days days Bilirubin ULN x 1 5 Wises 15 Bilirubin ULN x 3 Psw 30 49 Clinical Data Management Unit Calculator gt For some lab values there is the possibility to convert lab values should you have other units at your site Use score to calculate the asked conversion and add the calculated value in the appropriate field above UNIT CALCULATOR INSTRUCTIONS This calculator can be used to convert lab values in case other units are used as standard at the site Note that converted lab values have to be entered manually in the upper part of the CRF Total bilirubin mg dL to pmol L Converted value A mg dL Wise mol L Serum creatinine mg dL to pmol L Converted value i mg dL Wiser mol L 50 Clinical Data Management 11 7 2013 25 11 7 2013 AE reporting 51 Clinica
22. its 1 Click next visit 2 Choose unscheduled visit e g End of treatment The planned date is already filled in change if necessary Click Save Next visit Please specify if the next visit a regular or unscheduled visit in compliance with the study protocol Unscheduled visits are ignored during the generation of the regular visit plan Repeat previous group of planned visits Visit 8 Unscheduled visit End of treatment Date 22 03 2013 dd mm yyyy CETICEST Cancel Save 3 The next form will open automatically 32 Clinical Data Management 11 7 2013 16 11 7 2013 Data Entry 33 Clinical Data Management Data entry All forms are entered online by the site staff except forms SAE and PRF In case of system breakdown an emergency E form gt SAKK website can be sent by fax The forms SAE and PRF are sent by fax and entered by SAKK CC staff Never close a form switch from one form to another change the browser page use the backwards function of the browser or leave the computer without saving the data otherwise the entered data will be lost 34 Clinical Data Management 17 11 7 2013 Accessing patients Repor New patient seet gt 1 Click on Reports choose Patient overview choose patient number see Reports amp Statistics gt This function is only accessible from the welcome page Reports Statist SAKK 08 11 SAKK 08 11
23. l Data Management AE reporting The investigator has to report all AEs according to the protocol The start and end date as well as any change in grading have to be reported Baseline symptoms have to be recorded and followed during treatment 52 Clinical Data Management 26 AE reporting Click on Adverse Events tab Click New Adverse Event Visit plan Adverse Events Other Forms New Adverse Event gt Choose Adverse Event and click Continue New Adverse Event Adverse Event 53 Clinical Data Management AE reporting 4 Tochoose the CTCAE term click on Catalog 1 ADVERSE EVENT ome System organ class SOC Term If other specify below Specify other here Comment Start date Grade Relation to treatment Help lt Pleasechoose gt v lt Pleasechoose gt v Comment Still ongoing at 30 days after treatment or prior to next treatment _ End date not applicable Cancel Save Save closeentry 7 Check data Date 06 09 2012 CEST Developer Miriam Wegmann Project SAKK 08 11 05 09 2012 07 24 08 CEST Centre Spitatxy 0811 Country Pat ID gis494 UPN 0811_027 1 AE Adverse Event 06 09 2012 CEST Form family Adverse Events Form AE Adverse Event A SAKK 54 Clinical Data Management 11 7 2013 27 11 7 2013 AE reporting 5 Enter the term or a symptom into the Search for text field and click Search
24. ort or Patient overview check for queries gt Only accessible from the welcome page SAKK 08 11 SAKK 08 11 Accrual 2 Enter patient number into the Select field press enter check for queries 64 Clinical Data Management 11 7 2013 32 11 7 2013 Finding queries Reports Query report gt All queries are listed gt Filter them according to the status Query answered Query asked v Query resolved vy lt All gt lt All gt v lt All gt X lt All gt v lt All gt lt All gt v 248 fse702 Spitalxy 0811 Wegmann 08 02 12 E5 Laboratory Values Absolute neutrophil count ANC M 249 fse702 Spitalxy 0811 Wegmann 08 02 12 E4 Physical Examination WHO performance status 287 wsb520 Spitalxy 0811 Wegmann 28 06 12 28 06 12 E1 Information on Patient Registration Did the patient agree that urine samples and tissue samples are being used in scientific studies for further research 58 wsb520 Spitalxy 0811 Wegmann 28 06 12 E1 Information on Patient Registration Did the patient agree that samples data may be used in as of yet undetermined biomedical research projects without being informed in specific instances and providing consent 89 wsb520 Spitalxy 0811 Wegmann 28 06 12 28 06 12 E2 Inclusion Criteria 65 Clinical Data Management f SAKK Finding queries Reports Patient Overview gt Find queries via symbols Zl Visit 3 Visit 4 Visit 5 Visit 4 Visit 5 Visit 6
25. queries are marked with a A 70 Clinical Data Management 11 7 2013 35 11 7 2013 Reports and Statistics Reports amp Statistics gt All reports are accessible from the welcome page by clicking Reports New patient Select gt gt You find all reports listed under the appropriate trial SAKK 08 11 36 Reports amp Statistics gt One most used report can be chosen under my account iy Account TY essages Import Reports New patient Select gt Last name Wegmann First name Miriam Title Gender Female Male Phone Mobile phone Fax Email miriam wegmann sakk ch Private location Street Zipcode City Country lt Please choose gt v Prete SAKK 08 11 U0811 1 0Patientoveview E only as menu tem Preferred language gerau gt The link to this report will appear in the task bar on every screen TO Patient overview D yAccount Messages Import Reports New patient Select gt 73 Clinical Data Management 1 0 Patient overview gt Summary of the form status gt The level of detail can be chosen in the header gt Explanation on the symbols can be found via the help of the visit plan see data entry gt Click on a patient number the form overview of the patient will be opened 74 Clinical Data Management 11 7 2013 3 75 76 11 7 2013 2 0 Query report lt All gt lt All gt v lt All gt
26. treatment Start date Grade Relation to treatment End date So E dd mm yyyy lt Pleasechoose gt v lt Please choose gt v gtin ongoing at 30 days after treatment or prior to next treatment C End date not applicable gt In case of changing grade enter an end date click more and enter the new start date grade and relation to treatment Start date Grade Relation to treatment End date 01 09 2012 dd mmyyyy 2 Moderate v 1 Unrelated v 02 09 2012 dd mmyyyy Start date Grade Relation to treatment End date 03 09 2012 dd mmyyy 1 Mild 1 Unrelated X 05 09 2012 dd mmyyyy Still ongoing at 30 days after treatment or prior to next treatment C End date not applicable 58 Clinical Data Management 29 11 7 2013 AE reporting ongoing 9 a AE is ongoing Leave the end date empty save and confirm the missing end date by clicking save again Start date Grade 01 09 2012 ddmmyyyy 2 Moderate gt A grey exclamation mark indicates that AE reporting is not completed gt As soon as one AE is filled in the tab color Adverse Events changes to red Visit plan Adverse Events Other forms 1 Fever 59 Clinical Data Management AE reporting resolved 9 b AE is resolved Enter end date click Save close entry and go back to the form overview Start date Grade Relation to treatment End date 01 09 20
27. yy CETICEST Visit 4 28 11 2012 CET 3 11 2012 samm yry corvcesT Dale Cancel Reser 28 Clinical Data Management 14 11 7 2013 Deleting pre defined visits 3 Enter a reason for deletion and confirm by clicking Save Edit Visit plan a its wil be shift ed accor ngy as long he dates has not been changed for thersobes or the last unscheduted wat of the same as tl type without data entry can be deleted 05 09 2022 CEST ant Vist 05 09 2012 CEST 05 09 2012 CEST gt Do not delete visits if they should have taken place gt Only delete visits if they are already pre defined but the patient got off study earlier or visits were added by mistake gt You can only delete empty visits 29 Clinical Data Management Adding scheduled visits 1 Click next visit Visit plan Adverse Everts 30 Clinical Data Management 15 Adding scheduled visits 2 Choose scheduled visit Visit No The planned date is already filled in change if necessary Click Save Next visit Please specify if the next visit a regular or unscheduled visit in compliance with the study protocol Unscheduled visits are ignored during the generation of the regular visit plan Scheduled visit Visit 5 Unscheduled visit End of treatment Date 26 12 2012 dd mmyyyy CETICEST Cancel Save 3 The next form will open automatically 31 Clinical Data Management Adding unscheduled vis

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