Short introduction. for the. the NIC-PD study. - productive and training database -

Transcription

1 Short introduction for the Secutrial ecrf system of the NIC-PD study - productive and training database - last modified: EudraCT / by CIO CNP ver

2 CONTENT Browser start... 3 Browser tips... 3 Internet addresses (URL) of the NIC-PD ecrf system... 3 Login with test accounts... 4 How to request a individual user account... 4 Notice: Use ONLY the program buttons for navigation!... 7 Your first look? Read the Welcome page... 8 Context sensual help pages... 8 Enter a new patient... 8 ecrf form types and families Edit and save data Data Entry complete Navigation between forms and overview Visit date forms Meaningful icons and symbols in Secutrial Special entry fields: catalogues, repetition groups and scores Form functions: print, comments, queries, audit trail, help Plausibility and completeness checks Symbols for validity warnings and errors Save data without validity check Verification forms Forms with need for electronic signature Further work: selecting an existing patient by entering the study ID Visit dates calculation and overview Change the system s visit plan dates, if needed What to do if an execution date exceeds the allowed visit time range Create unscheduled visits Reports and statistics Selecting an existing patient record by using a report For documentation: print the patient s file The messaging function Reporting Adverse Events (AE) The monitoring workflow The Query system A special report: Query details Source Data Verification (SDV) Changing SDV-Status in forms Monitor review Data management review The Audit Trail My Account Additional specifications EudraCT / by CIO CNP ver

3 Browser start Start your web browser. Browser tips The Secutrial ecrf system is optimized for an easy use with Mozilla Firefox, SeaMonkey, Opera or Chrom. If you want to see new messages or reports directly at database start you only have to enable the popup feature of your browser. If you want to use the Microsoft Internet Explorer: You have to uncheck the option "do not save encrypted pages to disk" in internet options/advanced. You have to check the file download options in the security settings: Internet addresses (URL) of the NIC-PD ecrf system If you want to work with the training system to train the ecrf system, use: DataCapture.woa/wa/choose?customer=NIC If you want to work with the productive system and enter real patient data, use: DataCapture.woa/wa/choose?customer=NIC EudraCT / by CIO CNP ver

4 Login with test accounts For a first non individual login at the training system you can use the following test user accounts: For a login with rights of a clinical investigator (may enter new patients and see all forms except Hoehn&Yahr and UPDRS): Username: testusa Password: nictrain01 (belongs to Testcenter USA) Username: testger Password: nictrain01 (belongs to Testcenter Germany) For a login with rights of an UPDRS rater (may not enter new patients, may see only Hoehn&Yahr and UPDRS forms): Username: updrsusa Password: nictrain01 (belongs to Testcenter USA) Username: updrsger Password: nictrain01 (belongs to Testcenter Germany) For a login with rights of a monitor: Username: moniusa Password: nictrain01 (may see Testcenter USA) Username: moniger Password: nictrain01 (may see Testcenter Germany) How to request a individual user account a) To request your individual access to the NIC-PD training system please complete the User Accounting Form provided in the investigator site file (ISF) and send it to your country specific project management (PM) GERMANY: send via fax to KKS Marburg: US: send via to Rochester: Cornelia.Kamp@cmsu.rochester.edu b) The PM will check if you are registered for the NIC-PD study and come back to you in case of clarification (e.g. in case of missing CVs, qualification certificates, etc.). EudraCT / by CIO CNP ver

5 PM will complete the form concerning your role and rights, sign and send it to the Central Information Office Competence Network on Parkinson s Disease (CIO), which supporting the ecrf system. The CIO will install your individual access to the training system and inform you about your access data via . Notice: At the first login with your individual account to the training system you have to change the start password to an own password (at least 8 digits long, at least 1 digit non-alphabetic). In this first step you are enabled to access the training system only. If it is your first visit in a SecuTrial ecrf system, please read the information on the Welcome page: After you have trained with your individual access and are familiar with the training system you can request your individual account for the productive system. This can be done with the Access Request form. This form is located at last form of the Baseline visit. Please fill out this form. EudraCT / by CIO CNP ver

6 c) To request your individual account for the productive system, please enter the needed information in the Access Request form. With this request you confirm that you feel confident with the EDC (Electronic Data Capture) system and that you are adequately trained in terms of use. Saving this form documents your request. CIO and PM will be informed via an automatic system that you feel to be adequately trained and apply for access to the productive system. EudraCT / by CIO CNP ver

7 After receiving this system created automatic the CIO will install your individual access to the productive system and inform you about your access data via . Notice: At the first login with your individual account to the productive system you have to change the start password to an own password (at least 8 digits long, at least 1 digit non-alphabetic). You are now able to access the productive system at: DataCapture.woa/wa/choose?customer=NIC For your convenience you may save the link as a bookmark. Alternatively you can use the installed link on the Login page of the training system: Enter your username and password and press the LOGIN button. Notice: Use ONLY the program buttons for navigation! IMPORTANT: Only use the program buttons to manage the database. Don t use the browser buttons! EudraCT / by CIO CNP ver

8 Your first look? Read the Welcome page If it is your first visit in a Secutrial ecrf system please read the information on the Welcome page. On the bottom of the welcome page you find the information for download and print out, e.g. the study protocol.. It offers several important Context sensual help pages Every page of the ecrf system offers a special help page. Please click on the HELP button if you want more information. Enter a new patient Clicking on the NEW PATIENT button will open a new page with the form for establishing a new patient.. First you are asked for the patient s study ID. Please enter exactly 3 digits. The system uses your center s prefix and these 3 digits to create the study ID (for example: US-TEST-001). The system takes care for unique IDs. EudraCT / by CIO CNP ver

9 This Study-ID will then be allocated to a new patient record. With the complete Study-ID of a patient (e.g. GE or US ) you can reach the patient s data in the system. Please enter the date of the screening visit. This date is used by the system to calculate the visit plan. A message will appear confirming that the study ID creation was successful and a database record for this patient has been added. Click on CONTINUE to proceed to the patient records overview. IMPORTANT: This is the confirmation, that a new database record for the new patient was created. If you interrupt before this confirmation, no database record will be created. Remember to notice the patient s study ID in the patient s study file! Click on to access the patient s visit plan overview. EudraCT / by CIO CNP ver

10 ecrf form types and families After you have generated a new patient record, the form overview appears. All forms for all regular visits (Screening, Baseline, Telephone visits and Follow-ups), sorted logically in form families, are shown on the overview screen. The patient s visit plan overview is the central access point for data entry. Notice: The patient s form overview is the central access point for data entry. (The little indicate, that the source data verification function is activated; see below.) symbols There are three types of forms: Visit forms contains all the different forms to be used according to the visit plan described in the study protocol. Adverse Events (AE/SAE) contains the forms to report adverse events. Case forms contains forms only used once for a patient (for example termination / premature end ) or are sampled in one form continuously during the study (for example Concomitant medication ). Form families are always listed at the left side. A form family may contain one or more data forms. Click on a form family icon. If a form family contains only one data form, it will open immediately. If a form family contains several data forms, you will see them listed at the bottom of the overview. EudraCT / by CIO CNP ver

11 Clicking on a form icon - for example opens the data form. Edit and save data Open the form you want to fill in by clicking on the respective icon on the overview page. Here as example the Demographics form: Notice: Mandatory fields are marked with a red star *. They have to be filled out in every case. Conditional mandatory fields are marked with a red star in brackets (*). They have to be filled in the consequence of a previous answered field. In this example from the Medical History all following questions have to be answered, if the question Was the patient already PD treated? is answered with yes. When you have edited a form, please make sure to save the data by clicking SAVE or SAVE + CLOSE ENTRY on the bottom of the form. If you leave a form with CANCEL or BACK before saving the data, the form data will not be saved. IMPORTANT: If you do not save, the entered data will be lost. EudraCT / by CIO CNP ver

12 Data Entry complete This function is to show the monitors, that a single form is entered completely and is ready for monitoring. After entering data into an entry form you can decide to SAVE the data (that means, that the data entry is not complete and you will do further entries or changes) or to SAVE + CLOSE ENTRY. Notice: Before an entry form is not marked as entry closed the monitor does not have the possibility to enter a query. After a form is marked entry closed you will not be able to change data in this form. The monitor can enter queries by using the Query button on the right side of a question: Notice: If you marked SAVE + CLOSE ENTRY by mistake, you can reopen the data entry form with the REOPEN DATA ENTRY button, but only, if no monitor query is entered: Then a monitor query is entered, you can no longer reopen a form and change all data. You can only change the data of the question according to the query of the monitor (see next section: Query system). Notice: In the following case forms the button save + close entry are suppressed for users with the role of a study nurse: 1. Drug Accountability Log 2. Drug Exposure 3. Concomitant medication EudraCT / by CIO CNP ver

13 In these forms repetition groups are imbedded. Repetition groups are used for entry fields that can be needed once or several times, for example a patient can take one or several concomitant medications. The forms are to be filled out over the whole duration of the study. If the data input is completed the forms can be save + close entry by the clinical investigator. Navigation between forms and overview When you have finished the form and saved the data successfully, you will see the following notice: Clicking on will bring you step by step to all forms of this visit. But you can choose to go back to the overview or back to the just saved form as well. Back to the form overview you see, that the last edited form changed its color (see meaningful colors below): EudraCT / by CIO CNP ver

14 Visit date forms Each visit has an individual visit date form; the time lag to Baseline visit is calculated and the allowed days for this visit are shown. The date you enter here will then appear in the form overview below the planned visit date. Meaningful icons and symbols in Secutrial To support your work with a Secutrial ecrf system a sophisticated system of meaningful icons and symbols is implemented. For example: the appearance of the icons will change to darker shades depending on the completeness status of the data forms (empty, partially completed, completed). On a patient s form overview clicking on the HELP button on the right top of the page will lead you to the Help Form overview page. This page provides explanations for all overview, validity check and completeness symbols: EudraCT / by CIO CNP ver

15 EudraCT / by CIO CNP ver

16 Special entry fields: catalogues, repetition groups and scores You will know most entry field types of the Secutrial ecrf system from other internet forms: free text fields, radio buttons, check boxes and pull down menus. Secutrial implements three additional types: catalogues, repetition groups and scores. The Concomitant medication form in the Case Forms uses for example a catalogue and repetition groups. A catalogue normally contains large amounts of entries (in case of the NIC-PD study the ATC-Code catalogue for medications with more than entries) hierarchical ordered. In a catalogue you can scroll through the entries or search for a term. In the upper part you can define your search. You can enter a word or a combination of signs. Your search term will be searched in the whole catalogue and will result in every adequate catalogue entry. The findings are shown heavy typed and yellow marked. Alternatively you can scroll through the catalogue with help oft the triangles on the left side. EudraCT / by CIO CNP ver

17 With a click on a triangle you can open and close the different catalogue levels. With a click on the searched entry it will be copied to the form entry field. Data of higher-ranking levels will be inserted as well. Catalogue fields allow manual entries, but only if they are contained in the catalogue. At storing the system checks the consistency between catalogue and form entries. If your manual entry is not exactly included in the catalogue, you will get a warning. Repetition groups are groups of entry fields that can be repeated as often as needed. They are used for entry fields that can be needed once or several times, for example a patient can take one or several concomitant medications. By clicking on the button you create a new entry group. You can create as many entry groups as needed. By clicking on the button the group can be deleted (but only, if there is no comment or query entered; this is explained later in this manual). Scores are used in the Secutrial ecrf system to calculate for example the total score of a neuropsychological scale or the duration of a disease. Some data forms can contain several scores, for example for subscale calculations. Please notice: if a form is stored once, and you come back and change data entries, the score will not show the new calculation at once. But the new calculated score will be stored in the system, then you save the form. If you want to see the new calculated score, you can tick on the according single the button or use button on the bottom of the form to calculate all included scores of the form. EudraCT / by CIO CNP ver

18 Form functions: print, comments, queries, audit trail, help Additional to the buttons, you already know (HELP, LOGOUT for example), in a data form you have some more available: BACK brings you back to the form overview. The PRINT button prints out the current form. The buttons COMMENTS and QUERIES provide access to the comments entered and to all query (open, answered or resolved) entries. The AUDIT TRAIL shows the history of all data changes. It does not appear until the form has been saved for the first time The HELP button on the top of the page provides detailed information about the form functions of this special form. Notice: If a single question. button appears on the right side of a question, it provides more details about this Plausibility and completeness checks To minimise the likelihood of erroneous entries into the system and increase data quality, many validity rules (e.g. for completeness, plausibility, ranges, formats) are implemented in the Secutrial ecrf system for the NIC-PD study. They point out any improbable or incorrect data to you at the time you save a form. Checks usually concern formats (e.g. you cannot enter February 30th as a date, neither alphabetical characters in a number field), and logical probabilities (e.g. pregnancy only if gender is female) and limit values (e.g. human pulse is unlikely to be higher than 250). If you try to save a form with erroneous entries, the form will open again and you will see error warnings in red colour. EudraCT / by CIO CNP ver

19 Symbols for validity warnings and errors A warning shall show you that something seems to be not plausible. Normally you can leave a form with warnings regularly with storing it a second time (click SAVE again). To help the trial management to understand these warnings (and save unnecessary queries) you are asked to enter a short comment for warnings. For example: measure is correct or value confirmed. In the form overview forms with warning(s) are marked with an exclamation mark in grey colour. An error shall show you, that obligatory data are missing or a value is definitely wrong (for example: February 30). You can save forms with error(s) only by deactivating the Check data function (see below). To avoid queries you should enter a comment for fields, you have to save without corrected error (for example: no patient answer available ). In the form overview forms with error(s) are marked with an exclamation mark in red colour. Save data without validity check If you want to save a form without a system validity check (e.g. in case you have to interrupt your entry work or in case you really are not able to correct an error due to missing values) just remove the tick in the field Check data. You can always come back and correct or enter the rest of data later. Verification forms In the NIC-PD study four different verification forms are used. For GCP reasons only clinical investigators are allowed to verify the entered patient s data with these forms; while study nurses or study coordinators may only read. 1) After all data in the visit forms of a single visit are entered, the clinical investigator should check all visit forms and verify with the Visit forms verification.. 2) After all data in the according case forms of a single visit are entered, the clinical investigator should check the case forms and verify with the Case forms verification. 3) The UPDRS rater has an own verification form to verify his entries in the Hoehn & Yahr and the UPDRS I-II and UPDRS III form for each visit. 4) At study termination the clinical investigator should check all Case form entries and verify with the Final Case forms verification. EudraCT / by CIO CNP ver

20 Forms with need for electronic signature Some forms of the system needs an electronic signature; that means they have to be signed with entering the clinical investigator s username and password: Due to GCP and their importance for correct study data the following forms have to be signed with an electronic signature: Inclusion / Exclusion criteria All verification forms Subject withdrawal / termination AE report form Important notice for study nurses and study coordinators: Because these forms have to be signed in addition by the clinical investigator, please only these forms, do not use. Further work: selecting an existing patient by entering the study ID To work with the data of an already existing patient, please enter the patient s study-id in the field on the Welcome page and click the Select-button or press <ENTER>: Alternatively you can use a report to get access to the data of a patient (see below). Visit dates calculation and overview Depending on the date you entered at creating the dataset for a new patient (the date of the Screening visit), the system calculates the dates for the following visits according to the study protocol. This planned visit dates are shown in the patient s form overview: Notice: You can print out this patient s overview with the print option of your browser to provide your patient with his visit plan dates. EudraCT / by CIO CNP ver

21 Change the system s visit plan dates, if needed As described above the system calculates the planned dates for the visits according to the study protocol. Base for this calculations are the date for the Screening visit and the date for the Baseline visit. 1) It sometimes happens that a wrong date for the Screening visit was entered. In this case you can correct the visit plan dates by clicking on EDIT VISIT FORMS (on top of the patient s form overview). 2) A specialty of the NIC-PD study is that there can be a less or more time lag between Screening and Baseline visit date. To update the visit plan in this case you can simply enter the new Baseline date. All following planned visit dates will automatically be recalculated. After you have corrected visit plan date(s), click on to see the new visit plan date calculation: You have to enter a reason for the change. History of changes is visible with Show history. EudraCT / by CIO CNP ver

22 What to do if an execution date exceeds the allowed visit time range Notice: In the NIC-PD study protocol the range for each visit is defined +/- 7 days. If your patient stay for several days in the clinic and the execution date of a single or several neuropsychological assessments exceeds this range, you will get a system error. In this case please enter a comment, confirm your entry with a second SAVE and complete a paper based File Notification. The form will be shown as in the form overview. This sign will remember you and the monitor that a File Notification has to be documented. Create unscheduled visits According to the study protocol of the NIC-PD study there are 3 kinds of unscheduled visits. 1. Symptomatic treatment In subjects requiring or requesting a symptomatic therapy the procedure will be as stated below: In the subgroup of subjects requiring a symptomatic treatment during the course of the study, start down titration over 3 weeks and if possible add weeks completely without treatment (complete wash out) or in case it is needed use the prolonged down titration scheme. Endpoints including the total UPDRS score (part I, II, III) will be determined as described prematurely prior to initiation of the symptomatic treatment. Values will then be extrapolated as described in the SAP. Visits will be performed as described Visits at wash-out phase, and the procedure described for withdrawal has to be followed: An unscheduled visit (full program) before reduction, an unscheduled visit (full program) after 3 weeks, an unscheduled visit (full program) after additional 5 weeks (= 2 months) If possible the patient should be kept in the study (just without study treatment) and the scheduled visit V6 (after 52 weeks from randomization) and V9 (after 60 weeks from randomization) should be performed Enter the date of the unscheduled visit. The system will sort your created unscheduled visit in chronologic order in the form overview and offer the according data entry forms. EudraCT / by CIO CNP ver

23 2. Unscheduled Visits during any phase of the study: Unscheduled visits are made in response to events during the course of the trial, for example, withdrawal of subjects or premature termination from the study, adverse events, requirement of a symptomatic treatment etc. For unscheduled visits, at a minimum the study procedures as defined for Visit 3 (safety assessments) should be completed. At each in-person visit subjects will be required to bring back any unused study medication and their completed drug compliance diary. Returned patches will be counted and recorded on the drug accountability form and the drug compliance diary will be reviewed with the subject. Subjects who decide not to continue with the study medication or who are withdrawn from the study please perform activities according to visit V9 (full programm including primary and secondary objectives). In such a case start the down titration of study drug slowly to avoid withdrawal symptoms (3 weeks) and complete the washout (if possible) over another month (5-6 weeks) without any nicotine. All examinations for final evaluation described at V6-V9 should be performed. Please click create follow-ups / unscheduled and choose unscheduled reduced program in this case. Enter the date of the unscheduled visit. 3. Premature End The patient will not complete the study and you want to enter the according data entries for premature end. Please click create follow-ups / unscheduled and choose premature end in this case. Enter the date of the visit. EudraCT / by CIO CNP ver

24 The system will sort the premature end visit in chronologic order in the form overview and offer the according data entry forms. Reports and statistics Several REPORTS and STATISTICS are available in a Secutrial ecrf system. Click on REPORTS on the Welcome page to open the list of available reports (and recruitment statistics) for the NIC-PD study. Reports (listed on the left side of the page) always show the data per study center. If you belong to only one study center, you will only see the data of your own center. Reports are created by the Secutrial ecrf system in just real time. The execution time depends on complexity of the report and the data volume. Statistics show the state of all data of all study centers in the system. They are updated once with 24 hours. Every day at 1:00 h am (MEZ) the system will be rebooted and is in this case temporarily not available. While there are some standard reports and statistics for each SecuTrial project, most of them are customized for the special Secutrial project. During the runtime of a project more and more reports can be added due to special interests of the trial management or the participating centers. Notice: In the NIC-PD study Recruitment Statistics are only visible for the monitors and the clinical coordinators of Germany and USA. You can print out each report or statistic by clicking the PRINT button. Most of the customized reports can be directly opened and saved in EXCEL format by clicking the EXCEL button. EudraCT / by CIO CNP ver

25 Notice: Some reports (for example Data Set completeness check or Query Details) would be senseless as download. They are only for print out. The report Data Set completeness check can help you to control the work of your own study center. It shows the real time completeness status of every visit of every of your centre s patients. Several symbols (see symbol list below) specify the data set state: Selecting an existing patient record by using a report You can use a REPORT to select an existing patient record. A click on a patient s Study-ID immediately opens the patient s data form overview in a second browser window. For documentation: print the patient s file With the function PATIENT FILE (on top of the patient s form overview) you can print out the patient s data for your own documentation. You can choose between single or all patients, single or all visits and single or all forms. In addition you can choose to include queries and comments, the audit trail or uploaded image files (if this function is used in the project). EudraCT / by CIO CNP ver

26 The messaging function The Secutrial system is programmed to work very close to legal requirements of data safety, security and individual rights requirements of different countries. Due to this a messaging system is implemented. Certain events you report inside the Secutrial ecrf system produce automated messages to all whom it may concern, e.g. when a patient has withdrawn his consent. Additionally, the SecuTrial ecrf system provides a simple messaging function for individual exchange of information. Clicking on the MESSAGES button on the Welcome page gives you the opportunity to write and send messages to the administrative centers of the NIC-PD study. They will see your message as soon as they login to the NIC-PD study system the next time. To send a new message click on the SEND NEW MESSAGE button. Choose one or more recipients, enter the subject and a message text and on Save in order to send the message. All your received and sent messages are stored in a message history. With clicking on Read Messages or Sent Messages you can read them. Notice: If you want to see your new messages directly after login to the system, you have to enable the popup-feature of your internet browser. EudraCT / by CIO CNP ver

27 Reporting Adverse Events (AE) Forms for reporting an Adverse Event are under the Adverse Event (AE) tab. To enter data just click on New Adverse Event. AE report forms have to be confirmed with your electronic signature (enter username and password again). EudraCT / by CIO CNP ver

28 The monitoring workflow The Secutrial system knows several functions for supporting the monitoring workflow in a clinical trial or a medical register. The generic workflow normally is: For the NIC-PD study the following monitor workflow support functions are activated: Data Entry complete Query system Source Data Verification Review A and B setting EudraCT / by CIO CNP ver

29 The Query system After the data form is marked entry complete and if the monitor has questions, he can click the QUERY button at the right side of a question and enter a query. In the form a question with a Query is marked with a question mark in red color on the left side of the question: By clicking the QUERY button, the Query text can be read. By clicking on the small arrow the Query can be answered. Notice: EudraCT / by CIO CNP ver

30 To minimize clinical investigator s efforts in case of queries, for the NIC-PD study the system is configured to answer a Query automatically, if you change one or more values due to monitor query (queries). In every case you have to enter a short reason for modification. This modification reason is added to all open queries of this form, you have answered with changing values, e.g.: In the form overview there are three different symbols to mark forms including Queries: This form contains at least one open query. All queries in this form have been answered by the clinical investigator. Monitor has resolved all queries in this form. EudraCT / by CIO CNP ver

31 A special report: Query details To answer or resolve queries, the report Query details can be used. In this report all queries are listed: In this sample two queries are listed: the first answered and the second open. With a click on! or? or #xyz you will get more information about the Query text. A click on the patient s Study-ID will open the form overview of the patient in a second browser window. A click on the item text in this report will open the according data entry form in a second browser window. EudraCT / by CIO CNP ver

32 Source Data Verification (SDV) For quality control the monitors can use the source data verification feature. With this tool the monitors can document their comparison results between (paper) source data and study data in the system. The documentation can be done for a specific item, for the whole form, only a visit or with one click for the patient en bloc. The monitor has the right for editing or changing. User with other rights are only able to see the status symbols: The reset is possible on item level. If all form items have the same level, you will see the status on form level. After opening a form you will see the SDV HISTORY button. It will show you the SDV history for every item. This SDV history can be printed. As all other entries and changes the results of the source data verification are documented in the audit trail. Notice: To enter source data verification is only possible in forms with no queries or if all queries are resolved. If a form contains open queries, or answered, but not resolved queries, the system does not allow source data verification entries. Changing SDV-Status in forms For changing the SDV status of an item, the monitor can click on the symbol left the item. Following selections are possible: EudraCT / by CIO CNP ver

33 SDV changes can be done on form-, visit- or patient-level. Notice: The item status verified will be reset to not done if the value of an item was changed, e.g. due to answer a query, set after source data verification. In this case the whole SDV form status will be recalculated and a second source data verification has to be done by the monitor. EudraCT / by CIO CNP ver

34 Monitor review If all entries are correct and plausible (and the source data verification complete), the monitor can mark the single forms (or the complete visit) with clicking REVIEW A at the bottom of a form. Marked with Review A further data entries or changes are not possible. A form family with partly marked Review A forms. A form family with all forms marked Review A. (With Review A marked forms give the signal to the data management, that additional data management checks may be started.) If the clinical investigator wants to add or change data, after the monitor has marked a form with Review A, he can ask the monitor to REVOKE REVIEW A by clicking the button at the bottom of the form. After that the form can be opened again and data can be added or changed. Data management review According to the support contract between study management and data management the workflow can differ: In clinical trials (phase I to III) like the NIC-PD study monitors normally check permanent the entered data, the data management do regularly data checks in larger intervals. As described in the picture in the Monitoring workflow section, the data management will wait for its final data checks, until the monitor has marked a whole visit (all forms) or all patient s data for the whole study with Review A. If the system checks find discrepancies, the data management will set additional queries (or ask the monitor to do so). If all data are consistent, warnings, errors and missing data explained with comments, and no further data discrepancies found, the data management can mark the visit (or all patient s data) with REVIEW B. From this moment the data are finally quality checked and ready for statistical analysis or publication. The data of this form are marked with Review A and Review B. They are ready for statistical analysis. Notice: Forms or visits marked with Review B are frozen; further data changes are not possible. EudraCT / by CIO CNP ver

35 The Audit Trail For the NIC-PD study the database is configured to store a complete audit trail. That means that any data entries, modifications, queries, source data verification and review entries are stored with username, date and time. The Audit Trail can be opened with a click on the AUDIT TRAIL button on the top of each single form. A look in the audit trail can be helpful, if several clinical investigators or monitors work with the data of a single patient. If needed an audit trail can become very large! it can be printed. Notice: The Audit Trail can also be included in the patient file. EudraCT / by CIO CNP ver

36 My Account By clicking on MY ACCOUNT on the Welcome page you can see your own contact data. Please take care for their correctness. Please correct your contact data in the case something changes (e.g. your telephone number or address). After SAVE your corrected data are immediately transferred to the NIC-PD user management system. In addition you can choose your preferred report, if you want (e.g. the Dataset Completeness Check): This report will then open immediately after your next login to the system. (You have to activate the popup function of your internet browser). Alternatively you can choose for your preferred report. In this case the report will be shown as additional menu item at the top of each form shown in the system for fast navigation. Last but not least you can change your preferred language for the user interface from English to German. Additional specifications As described below, thousands of plausibility and completeness rules are implemented in the NIC-PD study system according to the regulations, described in the study protocol. The according error messages and warnings shall help the investigators and monitors to guarantee for a high data quality. In addition there are some rules implemented, which control the possibility of data form entries. In the following these rules and some global regulations are described. NIC PD study ecrf: date formats The date format used in this study is DD MM YYYY If the day is not known, use "15" for the day. If day and month is not known, use "01 07" DD MM. Written informed consent Date consent form signed has to be signed with the electronic signature of the clinical investigator is not allowed if patient signed 28 days ore more before Screening visit date is not allowed if patient signed after the day of Screening visit The different visit date forms EudraCT / by CIO CNP ver

37 Time lag to Baseline visit is calculated by the system to control the accordance with the planned visit dates; forms show the allowed days for this visit Pregnancy Screening Form must only be entered in case of a female patient with childbearing potential Vital signs (Follow up) Is the patient pregnant? Comment must only be entered in case of a female patient with childbearing potential Inclusion / Exclusion Criteria In /Exclusion criteria fulfilled is calculated by the system to control the Randomization form Randomization Will the patient be randomized? Randomization date Medication Ident number can only be answered "yes", if all in /exclusion criteria are fulfilled cannot be entered, if patient will not be randomized Thank you for your attention! Central Information Office Competence Network on Parkinson s disease (CIO CNP), University Marburg, Germany EudraCT / by CIO CNP ver