Registry Manual []
Contents
1. euroPa Patient Registry User Manual european network for parkinson s disease Content T nireriieie mr 2 1 1 System RedulFelmelils ues vicar ccisnmenncarinteccosebieseatacuacunteaiacnmay exceed SEM su gous dci unto cn ua ce END EET Eur aE diria 2 1 2 General Information for Participants eeesssessssssssssssssseseeeene nennen nnn nnns 2 2 Patent Data ENUY T 3 2 ACCESS irom Web T E 3 PE E o E EE TT E EE E E 4 ZO INOS PassWOl eean E E O E E T OEE EO 5 PAN CON O P E E A E E E 5 2 9 CCUG PAE n E E A E E A MM HUE 6 2 6 New Patient Create Pseudonym ssssssssssssessssssseee nennen nennen en nns n an nnns nnn nnne nnns 7 LAE Tcu eA OU A AUS accent can cena ENE EE E NE E E E E E 9 2 8 Matrix Patient Record OVErViEW ccccccseeceeceeeeeeeeaeeeeeeseeeeeseeeeeesaeseeesseeeeesseaeeeeseaseeessenseesaaeeeeesaaes 10 ZS OW P 13 2 10 Buttons specific TOI TOLITIS uic oca euet eria tpe Dv entem tco du bk cae a ha Ua ou Ey en Uma Re deu vu va E E A Sa 13 CNISNBSUTSICMEI s 14 PARI 10245 Gre napa SIR RR 15 Zend c 16 2 11 Buttons for Specific QUESTIONS cccccceeececeseeecaseeceaseeceaueecceneeseuaeecauaessageeseasee2. 2 Patient Data Entry 2 1 Access from Web Site You can access the application via the EuroPa website http www europarkinson net Under INTERNAL you will enter the password protected area that only EuroPa participants can access EuroPa Internal Netscape ee cies E ae lal xl File Edit View Go Communicator Help Mo LG I GDiGi ee a euroPa About EuroPa Members Activities Publications Parkinson s Disease Internal Patient Registry Internal Training Mode posginients Access to the internal area is only available for project participants funded by the European imprint webmaster top Commission Using the links on the left side you can access the EuroPa patient registry the training mode or the area to download documents The INTERNAL pages lead either to EuroPa documents that are available for download to the registry training mode where no valid patient data will be entered or the EuroPa patient registry Page 3 of 23 By clicking on PATIENT REGISTRY ENTRY you will enter the EuroPa patient registry If you have not yet received a user ID and password please contact Regina Wick wick staff uni marburg de Please use only this route to access the software Otherwise the windows may not open in the size intended We may also change the hidden address of the application 2 2 Login In order to log in user name ID and password are requested Your user ID was assigned to you along with your passwo
3. E Clinical Close 1 Interest in Please enter your comment 2 Participat Comment Queries Comments Audit Trail if YES spi 1 Interest in participating in clinical trials i uery enter your corment au Comment Inte ation date GS 2 dd mm yyyy Reset Entry Save Inte ation date n xii ui us F I dd mm ny Reset Entry bo e Cancel Save and Print Save ly Check data Date 14 03 2003 12 49 19 Investigator Dr Tamara Appelt Patient lwii58 Visit 12 03 2003 Project EuroPa Center Marburg Form Clinical Trial History Document NMr 45 9 Xe ED s EZ httpsifiass brainmedia dejcgi bin WebObject AAmIPvOBABdbbATUgZg 25 23 1 5 19 0 1 9 0 7 aE On the right hand side you find the COMMENT Button to enter a comment to the respective question answer Type a comment Submit by clicking on SAVE or Cancel by clicking on CLOSE and close the window without saving the comment Page 18 of 23 2 11 3 Query As an examining doctor this button gives you the option to answer a query Monitors enter their queries using this button T Welcome to the data entry for the EuroPa Version 1 5 10 Netscape pees BE 7 zr ADT 5 x File Edt View Go Communicator Help VREHETEEEIERG es tee UTUS Project EuroPa County Spain Welcome Help Logout UOP a Late 01 04 2003 14 189 Center Barcelona Investigator Dr Friederike Harz Patient wyal138 Haw Patient ee Select Patient Exit Pl
4. Only after all mandatory fields those that are underlined are filled in and a signed patient consent can be confirmed a pseudonym can be allocated Welcome to the data entry in the development mode ersion 1 6 Mozilla EN P oj xj File Edit wiew Go Bookmarks Tools Window Help Date 28 02 2003 sTToPa Investigator Susanne Schneider Welcome el bagani t ot Back Gender C Female Male Title OO Lastname Firstname Middle Initials City 7 Zipcode NEED i Street ore Country lt Please choose others o Biff 000 Birthdate I uy aic mim wy Birthplace Birthcountry Please choose w Others OOOO Patient Consent The patient has signed the consent Cancel Generate Pseudonym and Print Help After completing all mandatory fields click on GENERATE PSEUDONYM AND PRINT A new window opens with a print view of the core data and the pseudonym PID allocated to the patient Confirm the print message that appears automatically and the sheet will be printed out The patient personal data will NOT be stored in the database The only information that will later be transferred to the central server is the pseudonym Therefore make sure that you will be able to re identify the patient later on Save the print out with both information the patient s pseudonym and his her identifying data at a safe place at your centre The window that appears after a pseudonym has been allocated als
5. Click on LOGOUT to log yourself off and leave the input area Create New Visit For the EuroPa patient registry it is required to examine each patient at least once a year and to fill out again the minimal data set Therefore a case visit plan has been implemented in the registry application In order to define a new visit for the patient click on the NEw Visit button The date of the new visit should be the date when the patient will be seen again for a new EuroPa examination Welcome to the data entry for the EuroPal Version 1 5 10 Netscape E E ici xl File Edit wiew Go Communicator Help FXNTEETIDIEDGINENEBG NES euroPa Vale 01 04 2003 13 48 Center Barcelona e Investigator Dr Friederike Herz Patient walat Hack New Patient select Hext Visit Date Please enter the date for the next visit 31 03 2003 ded mrnwyy Save Cancel For a new visit the examinitation date has to be entered and saved Page 11 of 23 pra wa a the dag aen ai the EuroPal Version 1 6 10 Nets x Project EuroPa County Spain 72 euroP a Vale Mu COME ganou Investigator Dr Friederike Patient wal 36 Hew Patient Select Herz Welcome Help Logout Fatient Exit Planned Visits Previous 31 03 03 Mext visit Data entry vist 4 04 03 Personal Data Clinical Data Previous Drug Exposure Current Drug Treatment Clinical Trial Histary After having added another visit the most recent is shown
6. Investigator Dr Tamara Sppet Patient ijk147 vist 14 03 2003 Project EuroPa Center Marburg Form Personal Data Document NMr 49 2 CHE ER A ED ne 0 d a The structure of a form header footer and questions This is the first form in which the examination results are entered In the upper region form header the familiar details and buttons appear again Additional buttons refer to the present form Print Comments Queries Audit Trail To the right next to the questions there are buttons for Help Comment and Query For more details see below Once you have filled in a form please make sure to click on Save or Save and Print in order to transfer the data to the database Otherwise the data will not be stored and could get lost After having submitted a form you receive confirmation that your entries have been saved Here you can choose whether you want to jump directly to the next form if Next Form is available or back to the matrix if Next Form is unavailable Enter answers and or click on to answer If required enter or view comments Save form using SAVE or SAVE AND PRINT if a print out is needed 2 10 Buttons specific for forms The buttons for QUERIES COMMENTS AUDIT TRAIL lead to overview windows that supply views of all actions that have taken place in this open form The buttons are located at the top edge of the form in the header area as applicable
7. in order to enter data in the EuroPa patient registry The required application software is implemented at the central server in Marburg and will interact with you via the Internet by means of a normal web browser e g Microsoft Internet Explorer 90 all you need is a PC that is connected to the Internet and has a current browser installed System recommendations Windows MacOS or Linux operating system Browser Microsoft Internet Explorer version 5 x or later or Netscape 4 7 or later ideally 6 x or later Your browser settings are important JavaScript must be enabled your browser must accept cookies and SSL must be activated If possible the cache should be set to zero for security reasons You can deactivate Java and ActiveX For assistance please ask your local system administrator 1 2 General Information for Participants As you know you use the software via your web browser Certain features e g window appearance menus printouts can vary slightly depending on the type or browser version you use However all essential functions have been tested with all the different standard browsers Page 2 of 23 For data entry a new fixed size window opens The advantage of this is that the user interface always looks the same whatever PC and monitor you are working with In addition the browser s command elements back print etc are hidden when this window appears When you use the program you should only use the buttons in
8. minimal data set have been transferred into separated forms that can be opend and completed in Page 10 of 23 any order The PREVIOUS VISIT button which is shown only when there already are previous visits see below lets you view any preceeding visits For a each visit a new set of forms will be provided Visits are shown next to each other The appearance of the icons will change with respect to the status of the forms completeness comments queries etc For further information consult the icon legend which you can find using the HELP Button on the top of this page Clicking on an icon opens the according form In the header region of the window participant your name date centre and from now on the patient pseudonym should all be displayed correctly Once again you can see the LOGOUT and CANCEL discard changes and return to welcome page buttons If you want to log off and leave the system please always use this button rather than closing the window or exiting the browser program Finally you can also switch to a different patient record by entering the pseudonym in the text field clicking on SELECT A new patient will always be entered by clicking on NEW PATIENT Check details in the area at the top Click on the form you want to edit or Switch to other patients by entering the PID and clicking on the SELECT button or Return to the welcome page by clicking on CANCEL or
9. the EuroPa user interface don t use the browser buttons Otherwise it is possible that not yet saved data will get lost By clicking on the CANCEL button you will always get one step back to the previous window By clicking on the CLOSE button the current window will close and you can proceed with the next step By clicking on the LoGouT button you will be logged out completely of the application You have to enter your password again when you want to continue with data entry The EuroPa software buttons always appear at the top of the window There is an additional security feature If there is no contact with the server for more than 20 minutes you are logged out automatically This measure will ensure that no unauthorised person gain access to the database and make any changes to your records in case you have to leave your desk without having logged out first If you are logged out automatically any data that you have entered in forms but not yet saved click on SAVvE may be lost If you need to look something up or leave your desk save the form first even if it s not complete and then open it again later Data entered into the forms in your browser window will not be saved at the central server right away You need to click on the SAVE button in order to start the data transfer to the database Consequently if you know that you will be interrupted from active data entry for a while save your data first by clicking on SAVE
10. Page 13 of 23 2 10 1 Queries Queries are a tool for Monitors and other authorised users for example to conduct follow up investigations into unclear entries These are therefore questions that are put to you as an examining doctor and which you can a view and b if they apply to you answer In the Queries window you can see an overview of all queries and the answers in response to them that have been created for the entire form E Query Version 1 5 10 Netscape Project EuroPa Country Spain eurola Late O1 04 2003 14 57 Center Barcelona me Investigator Dr Friederike Herz Patient walsh Form Personal Data Queries and Answers 1 Date of Birth auper Dr Friederike Herz 01 04 2003 14 18 38 Are vau sure the Date of Birth is correct ANSWER Dr Friederike Herz 01 04 2003 14 25 12 4 Diagnosis aue Dr Friederike Herz 01 04 2003 14 55 04 Please check again whether iPD is still valid Time of symptom onset uen Dr Friederike Herz 01 04 2003 14 55 41 In case iPD is na longer valid please correcttime of symptom onset Using the QUERIES Button at the top of the page an overview is shown of all queries and corresponding answers of the form you are currently looking at Click on QUERIES button browse the overview Click on PRINT to print out the list or Click on CLOSE to close the window Page 14 of 23 2 10 2 Comments Every participant of a centre can enter commen
11. anned visits Previous 31 03 03 Mex wsil Data entry JH 94 04 03 Fatiant Data Clinical Data Previous Drug Exposure Current Drua Treatment Clinical Trial History Project EuraPa Country Spain wWlaltame Help Logout mp euroPa Date 01 04 2003 14 18 Center Barcelona Investigator Dr Friederike Herz Patent wal3b5 Print Bach Lip Queries Comments Audit Trail 1 Date of Birth Comment n6 fi 307 myr GC 2 Gender Comment female male Dueny C T Respective form with an open unanswered query indicated by the question mark The query to question 1 is shown and can be answered by pressing the Query Button next to it An overview of all queries to this form is shown when using the Query Button at the top of the page Page 19 of 23 Queries and Answers Version 1 6 10 Netscape Queries 1 Date of Birth Quer fram Dr Friederike Herz Are you sure the Date of Birth is correct Please enter your answer Save answer Query to question 1 and possibility to compose an answer to it which is saved by using SAVE ANSWER Welcome to the data entry For the EuroPa ershon 1 5 10 Netscape File Edt View Go Communicator Help ate ttl cat eredi roa rd ret a e Fr ject Eura Pa C nurdn Spain Welcome Help Logout ibPa Date 01 04 2003 14 18 Center Barcelona P Investigator Dr Friederike Herz Patient wyal3 amp Mew Patient Select Patient Exit Planned visits Previ
12. d https fiasB brainmedia de cgi bin WebObjects DataCapture woallfwolrl w Back Reload Stop Project EuraPa Country Germany euroPa Date 14 03 2003 12 39 Center Marburg Investigator Dr Tamara Appelt Patient lwi158 Welcome ueries DTTITITE Audit Trail Rate YES with any score above zero on item 17 of LIPDRS Il Caminen C yes no Query Currently on anti parkinsonian medication Comment yes Query Deep brain surgery Comment C yes Query First degree relative with PD or tremor Comment C yes Query if YES specify Comment 1 parent null Query J sibling null DNA sample available Comment C yes Query Cancel save and Print Save Check data Date 14 03 2003 1439 47 Investigator Dr Tamara Appett Patient lvil58 Visit 12 03 2003 Project EuroPa Center Marburg Form Clinical Data Document Mr 42 3 hl cHe ER VOCE ea pe 0000000000000 n The two possibilities to print a form Page 23 of 23
13. e consult the registry Please also observe the practice directions SOPs as regards choosing your own password imx This is the opening page for data entry It serves as a central point for various page groups messaging help and statistics views If there are any new messages these are displayed in a new window straight after logging in At the top left you can see your name and the current date Always check these details first to make sure you haven t inadvertently logged in to the wrong account The LOGOUT button here and in other windows logs you out of the system immediately Changes are not saved Please log out whenever you leave your computer so that nobody can use the system under your name After twenty minutes without making contact with the server you will be logged out automatically timeout If this happens you will also lose any unsaved changes From your user ID the system recognises which centre s you have access to The New Patient button lets you enter a new patient and create the according patient record In order to access an already existing patient record enter the patient pseudonym PID into the free text field Then click on Select to Page 5 of 23 view the according record for the patient By clicking on the HELP Button you will always receive additional information and explanations for the features available at the current page STATISTICS and REPORTS will be exp
14. f the present form It is important e g for studies and forensic purposes in order to be able to retrace what was changed by whom and when and what values see screenshot of the AuditTrail below the fields used to contain h Welcome to the data entry for the EuroPal Version 1 0 0 Mozilla File Edit wiew Go Bookmarks Tools Window Help a E E A Back Reload Stop sine E cw Ee Gu https Nias brainmedia deJcgi bin WweboObje wola 7 no8hhY TDBMBHx9S3WDMIZ3 5 43 5 2 3 1 Hu E A https fias brainmedia de cgi bin WwebObjects DataCapture woallfwofat Project EuraPa Country Germany welcome Help Logout euroPa Date 14 03 2003 13 13 Center Marburg Investigator Dr Tamara Appelt Patient Iwi158 Print Back Queries Comments Audit Trail B Clinical Data Cocumert Mr 42 3 1 E Audit Trail ersion 1 0 0 Mozilla Project EuraPa Country Germany Close euroPa Late 14 03 2003 13 13 Center Marburg 2 UPDI Investigator Dr Tamara Appelt Patient lwi158 T Use Form Clinical Data 3 UPDI Last edited by Dr Tamara Appelt First edited En Dr Tamara Appelt nt For p Last edited on 13 03 2003 1571 2 06 First edited on 13 03 2003 15 04 24 Audit Trail Fori Investigator Date Value diag If YES specify Dr Tamara Appelt 13 03 2003 15 12 05 Insomnia yes d Moto Daytime sleepiness no st REM behaviour disorder na Dr Tamara Appelt 13 03 2003 15 10 57 Insomnia yes lf YE Daytime slee
15. ient Heye Srt KH briiite i riil sriremi Civtaterd 2003 ney ye Query Cancel Save and Print Save Oe PS Se i lege De Tamara 5ppek Piet eS Whit dm p DO Pigan Daea Canar Msi Fami Pace Duda i8 pe Decunert Done de NF i EXP ue 6 Validity check findings are marked red and become visible after saving the form Checks will concern formats for example you cannot enter 30th February as a date and logic probabilities and limit values e g UPDRS III can not be negative or larger than 66 By default the application checks each form when it is saved against these predefined rules If discrepancies or errors are present the form is reloaded with red markings to show you where the errors are and what the problem is almost always in plain text Please correct erroneous entries and click on SAVE once again If there are problems or real discrepancies that cannot be resolved at that time e g a patient does not meet a certain criterion but you want to check this afterwards you can circumvent the form checking feature by clearing the Check Details checkbox at the bottom right in the form footer no tick in the box By default this checkbox is set tick in the box each time a form is loaded Page 21 of 23 rd tajeg EuroPa l Gemiany Welcome Hek Logou P CUO Dale 14 03 2003 12 38 er Marburg meestigator Or Tamara Appelt jent 5H Fatient Data 1 Date of Elrth Comment E Noo
16. in the patient matrix Te Welcome to the data En fi UE EuroPa Versu 1 5 10 Net ee i Project EuraPa Country Spain T _ ds Welcome Help Logout euroPa Late 01 04 2003 Center Barcelona 13 48 Investigator vii Patient walaB Mew Patient Celect Fatient Exit Planned Visits 01 04 02 31 03 03 Next visit Data entry 01 04 03 Personal Data Clinical Data Previous Drug Exposure Current Drug Treatment Clinical Trial History The complete patient matrix in the example containing 2 visits is shown after having used the Previous Visit link Page 12 of 23 2 9 Form SE Welcome to the data entry for the EuroPa Version 1 0 0 Mozilla File Edit View Go Bookmarks Tools Window Help m m a id A https Mies brainmedia def cgi bin WebObjects DataCapture woal liwo Y lt 2 Search c Back Reload stop Print Project EuroPa Country Germany Welcome Help Logout euroPa Date 14 03 2003 13 18 Center Marburg Investigator Dr Tamara Appelt Patient ijk147 Print Back Queries Comments Audit Trail A Personal Data Documert hr 49 2 Date of Birth Comment o3 f J b manny Query Gender Comment female male Query e C Date of examination Comment dd mm yyy Guery Diagnosis Comment IP gt Query if OTHERS specify Time of symptom onset Help leave MM empty if not known Comment 2000 mirc Query Cancel cave and Print Save check data Date 14 03 2003 13 21 41
17. lained further below From anywhere in the programme you can go back to the Welcome page by clicking on the WELCOME button 2 5 Selecting a Patient Welcome to the data entry in the development mode Version 1 6 Mozilla BE 2 121 xl To select a patients record from the Eie Edt wew Go Bookmarks Tode widow _ top database you need to know his or her BI ru eit ect wem e teseut pseudonym PID Enter the Simiste Neos Missade pseudonym in the input field and click CO s saibi on Select If you do not have access a rights for the selected pseudonym or a record under this pseudonym does not enter a new patient press New Patient Button exist yet you will See an error e change patient data enter respective PID and choose lt Select gt look at messages as the case may be compose a message lt Messages Button message look at reports Reports Button look at general statistics lt Statistics Button Please do remember that you are responsible for the personal data of your patients They have to be handled according to your national data protection regulations Steps for patient selection Enter the patient s pseudonym PID into the text field Click Select or press enter Page 6 of 23 2 6 New Patient Create Pseudonym In order to enter data of a certain patient for the first time a pseudonym needs to be allocated You will first enter the patient personal data core data
18. nt menu Ok Button Steps to enter a new patient Click on New patient e Enter core data for the new patient Complete all fields paying attention to formats Click on GENERATE PSEUDONYM AND PRINT Confirm print message Close print preview by clicking on CLOSE Page 8 of 23 2 Examination Date Next you will enter the date of examination when the patient was recruited for the EuroPa patient registry It is either the present or an earlier day Future dates are not possible ru Welcome to Ehe data entry for Ehe EuroPa Version 1 5 10 Netscape BEEN okl Fille Edit View Go Communicator Help EEEE e EEE omer E Froject EuraPa Country Spain Welcome Help Logout S U roPa Date 01 04 2003 Center Barcelona Investiqatar Dr Friederike Herz Back Include the patient intn the database Please enter date af examination and recruitment far the registry for Patient wala The pseudonym PID will then be stored and a patient record be created 01 p4 2002 dd mm yyy Save Cancel Ej a Document Dane e d cy 4 In order to include the pseudonym into the database the date of examination needs to be entered The new patient and his or her PID is transferred to the database only when you leave this window by clicking on SAVE As soon as the PID has been added to the database a notice of success is presented to you Page 9 of 23 gt Welcome to Ehe data e
19. ntry For Ehe EuraPal Version 1 6 10 Netscape File Edit View Go Communicator Help pe A A Project EuraPa County Spain Welcome Help Logout SUTO Pa Late 01 04 2003 Center Barcelona 1P Investigator Dr Friederike Herz Patient vva135 Back Hotice The PID has been added to the database successfully Continue After the PID has been added to the database successfully this notice screen is shown Enter date of examination e Click on SAVE Acknowledge with CONTINUE 2 8 Matrix Patient Record Overview H welrome to the date entry for the Burofa Version 1 6 00 Netscape E i e s zinix J Fis Edt Wem Go Communicstor Help amp Project EuroPa centy Spain Welcome Help Logout eurolPta ale 1 04 2003 13 48 enler Barcelnna lne sliga tor Or Friederike Here Palient wai 36 Hives Palieril 1 elect Patient Exi Planned Visits 0104 02 PMexdwsil Data entry Patent Data Clinical Gata Previous Crug Exoosure Current Drug Trealmeri Clinical Trial Hisl rg The matrix patient record Now the new patient has been entered into the database with his her referring pseudonym and the date of examination The window shows an overview of all forms for the current visit The matrix patient record overview is the central point for data entry The matrix composed of symbols or icons in the centre of the window gives you a quick overview of the status of the various forms Part A E of the
20. o contains a separate text field with all personal data listed separated by semicolons You can copy this data and paste it into a different programme for example Excel This will give you the opportunity to create your own little database for re identification purposes Please make sure that those data are not stored at a computer connected to the Internet You have to follow you local data protection guidelines and security policies for data mangement Page 7 of 23 3m Welcome to the data entry for Ehe EuraPal Version 1 6 10 Netscape Project EuraPa Country Spain Date 01 04 2003 Center Barcelona Lb euroPa 7 Investigator Dr Friederike Herz Hew Patient Pseudanym pzs444 The patient has signed the consent Gender male Title Last Name Strada First Mame Ricardo Se Bereit Middle Initials M Typ HP Lazenet 4200 PS City Batela kommentar HP 4200 DTH Zipcode 080326 Ausgabe in Datei umleiten Street Casanova Mo 2 Druckbereich Exemplare Country Spain v Alle Anzahl der Exermplare fh aaa CS Seiten wen ft tis B B oon Date of birth 01 06 1902 C Markierung zm Place of birth Madrid Country of birth Spain Abbrechen Close EuraPa 01 04 2003 Dr Friederike Herz Spain Barcelona pzs444 male Strada Ricardo M Barcelona 08036 Casanova 2 Spain 01 06 1902 Madrid Spain gt Core data and the pseudonym PID allocated to the patient can be printed using the pri
21. ompted to change your password again administrator who can assign a new password to you 2 4 Welcome Page Y Welcome to the data entry in the development mode Version 1 6 Mozilla le Edit View Go Bookmarks Tools Window Help Date 28 02 2003 15 49 euroP a Investigator Susanne Schneider Welcome Help Logout Statistics Reports New Patient Messages Select Welcome to the data entry in the development mode You can enter a new patient press New Patient Button change patient data enter respective PID and choose Select look at messages as the case may be compose a message Messages Button look at reports Reports Button look at general statistics Statistics Button Please do remember that you are responsible for the personal data of your patients They have to be handled according to your national data protection regulations x You get to the page for changing your password a automatically the first time you log in b by clicking on CHANGE PASSWORD on the login page 2 For security reasons there are minimum standards that your password must meet The password must be at least eight characters long and must contain at least one special character digits full stop hyphen etc It may not be identical to the previous password At intervals of three months After three incorrect entries your password is locked If this happens pleas
22. ous 31 03 03 Nextwsit Data entry JH 0404 03 Patient Deta Clinical Data Previous Drug Exposure Current Drug Treatment Clinical Trial History Patient matrix where all queries have been answered Click on QUERY answer a given query in the answer field e Click on SAVE to save in the database or Cancel by clicking on CLOSE and close the window without saving the comment Page 20 of 23 2 12 Validity Checks To minimise the likelihood of erroneous entries in the EuroPa patient registry and thereby increase data quality a number of checks have been implemented that point out any improbable or incorrect data to you when you save a form Welcome ta the data entry for the Europal Version 10 0 Netscape ENS x lul xj Ele Edt ew Go Communicator Helo Bookmarks Locaten tps jl ad besiennedia de car bin web bjech Daa ape moa g E Lr p 9 31 1 10 1 1 1 1 1 ik Fen ier bie HT LI ob ie ee E TNA E a ea ea ee eer So ae a ee a nn nae T E DON z Furor a ile 14 03 2003 11 01 nier Marburg i i ligal Dr Tamara Anpelt Paliart Mi158 Back Patient Data Please check following enkies betort saeing 1 Date of Birth Cearareni iene Ix the palienbw urig r siete l n 357 fi 2000 E zu vyvY A Gender tweed emak malg uar i C amp Date of examination Liwtatetti dd e phi thas 34 Man Conwrani Plasse thijs Query mf OTHERS specity T 5 Time OF ampio on
23. piness yes REM behaviour disorder yes Dr Tamara Appelt 13 03 2003 15 04 24 Insomnia yes J Daytime sleepiness yes REM behaviour disorder Tthe Audit Trail of a form displays all changes made and saved Click on AUDIT TRAIL to see the overview PRINT to print out the list or Click on CLOSE to close the window 2 11 Buttons for Specific Questions The buttons found next to the questions offer functions related to the particular question or question group There are buttons for HELP COMMENT and QUERY Page 16 of 23 2 11 1 Help Behind the HELP button you will find further information and instructions for the particular question If you are ever unsure how to answer a question first of all check to see if the HELP can clarify the situation W Welcome to the data entry for the Europal Version ETHLL M mu O xl Be Edt We Go Bookmarks Tools Window Hep amp 3 8 Back Forward Reload Stoo EuraPa Coun Germany euroa Date CL Bal a Us Due M E rur f Help Yersion 1 0 0 Mozilla Close Patient Data Time of symptom onset Date of Birth Cenmmani UK Parkinson s Disease Society Brain Bank Sonin Criteria for idiopathic Parkinson s Disease Commer female male modifi ed step Diagnosis of Parkinsonian Syndromes Bradykinesis Query E C slowness af initiation af valuniary movement wilh pragressme reduction in Date nf examination speed and arnplitude af repetalive ac
24. rd Enter user name exactly as received The user name is case sensitive e Enter password Click on LOGIN 3i Welcome to the data entry in the development mode Version 1 6 Mozilla E El E z mi x File Edit View Go Bookmarks Tools Window Help euroPa european network for parkinson s disease Welcome to the data entry in the development mode This area is non public and accessible far registered users only Members of the EuraPa network can apply for user registration and authentication If vau are a registered user please enter your user ID and password in the respective fields When you enter far the first time you will he required ta change you password t following logins you can change the password when manually using the change password button LIser ID Password Login Change password The Login page to the EuroPa database Page 4 of 23 2 3 Change Password When you log in for the first time you will be asked to change your password first This will ensure that you are the only person who knows your password tif Welcome to the data entry in the development mode Version 1 6 Mozilla Eie Edit view Go Bookmarks Tools Window Help euroPa european network for parkinson s disease Welcome to the data entry in the development mode PwWD CHANGE TEXT User ID Old password New password Confirm new password Login Cancel you are pr
25. ren vy ue 2 Gender Comment tamale mee uer er 3 Date of examination Comt EERE auey 4 Diagnosis Conmant z Flesse choose EI ures If OTHERS spaclhy 5 Time of eysptorm onset Hip leat MM emptis d real kridwen Commert ipn eus mmn Cancel Save and Print Date 14 03 200424234 meeskoor De Tanan Appet Patient lt 5B WISE 13 03 2002 Project EurcPm Center Marburg Form Personal Dates S Zh WE pu ea Done pA You can switch off the check functionality by un ticking the box This option can also be useful if you have to stop work or leave your desk in a hurry but want to save the entries without doing any checks fast save in this case clear the Check details checkbox click on SAVE click on LOGOUT and that s it However disabling the validity check should be used as an exception only Page 22 of 23 2 13 Print Print Dialog and Print View There are two ways to print out each form The PRINT button in the header prints the last version saved in the database you will find this button only when the form has already been saved at least once The SAVE AND PRINT button first saves the form with all data that you have added or modified and then prints it In both cases a new print preview window opens which you can close afterwards SH Welcome to the data entry for the EuroPa Version 1 0 0 Mozilla File Edit View Go Bookmarks Tools Window Help T p A a E
26. seageeseaseesoueteneeeess 16 VNWNE O E Y 17 NR EE II EE 18 P CE ET E p TE 19 2 12 Wald CNeEKS codomediemteip ipai ipM aire ER PME MUI NM E 21 2 13 Print Print Dialog and Print View sseesssssssssssseseeeenneennnne nennen nennen nnns nnn nnne nns 23 Page 1 of 23 e euroPa european network for parkinson s disease EuroPa is a non profit cooperative About EuroPa network of experts from European medical centers aiming at the improve Members ment of clinical research and treatment for persons with Parkinson s disease A Sees Activities growing central database of Parkinson patients from all participating countries will facilitate the work of EuroPa as a European clinical research and trial center Publications Parkinson s Disease The establishment of EuroPa is fun ded by the European Commission an 99 1 Introduction This manual will help you using the EuroPa patient registry online application By means of this application you will enter patient data into the central database the EuroPa patient registry and administer the records of your centre The manual will show you each step that is necessary to create a new record to complete the minimal data set and to manage and update the patient data once entered 1 1 System Requirements No special software needs to be installed on your PC
27. tions And at least one of the following Muscular rigidity GH rest tremor Posiural instability nod caused by primary visual vestibular cerebellar or proprioceptive desfuncton Query Corm meri Diagnosis Cameri A if OTHERS specify Time of symptom onset leave MIM emp f cot kaawen B uuu Cancel Save anc Print Save F cheek data Dm 12 0S A009 tered meeskoor Dr Tamar Apert Pahem hiss Mist 1s 0G 3000 Project GuroPa Center Meargurg Form Personal Data e El x6 fal fi hitpssifias brainmedas drca bin Wenchiect IUEPvOSABdBATUGZO T 7 23 1 5 19 4 1 9 0 1 3 p s A form and a EN Help window which is opened after having used the espe clive buon Click on HELP e PRINT the help text if needed Click on CLOSE to close the window return to the form Page 17 of 23 2 11 2 Comment You can write a new comment here If you only want to read existing comments click on COMMENTS in the upper area of the form window Welcome to the data entry for the EuroPa Version 1 0 0 Mozilla File Edit View Go Bookmarks Tools Window Help e Ba E Back Forward Reload Stop Project EuroPa Country Germany Welcome Help Logout euroP a Date 14 03 2003 12 39 Center Marburg E 2 Investigator Dr Tamara Appelt Patient Iwi158 Print Back Comment Version 1 0 0 Mozilla m ioj x
28. ts Comments are used to either leave remarks for unclear answers or to ask questions to yourself or other participants All comments entered for the present form are shown in an overview File Edit View Go Bookmarks Tools Window Help 4 3 B iri EJ 5 Print If Project EuraPa County Germany Welcome Help Logout mM euroPa Date 14 03 2003 12 39 Center Marburg Investigator Dr Tamara Appelt Patient Iwi158 j Back udit Trail E Comments Version 1 0 0 Mozilla Project EuroPa County Germany Close 2 Pan S toPP a Date 14 03 2003 12 38 Center Marburg ugs Investigator Dr Tamara Appelt Patient Iwi158 it YE E j Frint Form Clinical Trial History Comments 1 Interest in participating in clinical trials Dr Tamara Appelt 14 03 2003 13 03 48 enter your comment Reset Entry Cancel Save and Print Save check data Date 14 03 2003 12 49 19 Investigator Dr Tamara Sppet Patient l il58 Visit 12 03 2003 Project EuroPa Center Marburg Form Clinical Trial History Dacument Mr 45 8 He EE EE GA Done b 4 In the header you find the COMMENTS Button to see all comments to the question in the present form E Click on COMMENTS button view comments e Click on CLOSE to close the window or e Click on PRINT to print out the list Page 15 of 23 2 10 3 Audit Trail The Audit Trail is an overview of all changes that have ever been made to any questions o
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