1. EORTC Remote Data Capture System For trials with electronic queries
VISTA RDC rdc.eortc.be
EORTC Remote Data Capture System
For trials with electronic queries

2. What is Vista RDC?
Vista RDC is the web based Remote Data Capture application designed to enable the investigator, DM or RN to enter and edit data on-line and to send the CRF to the EORTC database.
VISTA-RDC:
User-friendly
Runs in a standard web browser (internet)
Does not require installation of any specific software

3. RDC is not used for …
Patient registration
Reporting SAE
QoL forms …

5. Log-In page http://rdc.eortc.be
Documentation
Request username & password
Account
study / patients
complete and/or sign (documented on the signature log)
Login

6. Main page
Study box contains « your » studies

7. List of patients List of « your » patients
appears automatically after study selection
Move to the next / previous page
(25 pts per page)

8. Patients’ status overview
nb of patients with requested forms
nb of patients with incomplete forms
nb of patients with complete forms
nb of patients with queries
Click on the blue text to display the list of these patients

9. Select a patient Open the patient ‘file’ by entering the seqID
Or open the patient ‘file’ by clicking on a patient
Open the patient ‘file’ by entering the seqID

10. Create an e-CRF – tab ‘Blank’

11. Create an e-CRF - Requested forms
If CRF has not been sent in due time, missing form queries will be sent  this will result in the creation of a ‘requested form’.
The form can be created by clicking on ‘create’
Form code
Form name
Reason why form is requested
Once the form has been created, it will disappear from the list of requested forms.

12. Requested form – not applicable
If a requested form can not be completed, click on ‘not applicable’, enter the reason and click on ‘Save’. The request will disappear.
Example:
Adverse event form for cycle 2 is requested, but cycle 2 was not given.

13. Requested form – not done
If data on a requested form can not be completed because the test or assessment was not done
 Create a form reporting it was not done, with the theoretical date and period

14. Create an e-CRF – Other forms
All CRFs remaining available for completion are displayed
in the section ‘other forms’.
Select the form you would like to create by clicking on ‘create’
Unisequential forms (e.g. on study form) can only be completed once (after completion, the form disappears from the list)
Sequential forms (e.g. follow-up form) can be completed as many times as needed (see instructions in the protocol or the CRF completion schedule)

15. Completing an e-CRF – types of data
Numeric field
Label field
Date field
Text field

16. Completing an e-CRF – assistance
Form instructions
Help function
Label instructions
Field instructions
Comment fields

17. Completing an e-CRF – collapsibles (1)
On some forms, some items are by default “collapsed” to make form navigation easier
These items can be expanded by clicking on the arrow

18. Completing an e-CRF – collapsibles (2)

19. Completing an e-CRF - Error messages (1)
The format of the field is displayed next to each field
When entering a wrong data format, a warning will appear

20. Completing an e-CRF - Error messages (2)
Value out of range – if a value is out of the defined range, a warning will appear
If a mistake was made, correct the value
If the value is correct, you can force the value
! Please check carefully before forcing

21. Save a form as incomplete
A form can be saved as ‘incomplete’ at any time by clicking on ‘Save’ or on ‘Save & Close’, even if mandatory data has not been completed.

22. Save a form as complete
When the form is ready to be sent, save it as ‘complete’ by ticking the box next to ‘Complete’ and clicking on ‘Save’ or ‘Save & Close’.
If there are required fields that were not completed, a warning will appear

23. Cancel - Delete
If you do not want to save your changes, click ‘Cancel’
If you want to erase a form, click ‘Delete’

24. Edit or view an incomplete or complete e-CRF
The number of incomplete / complete forms is displayed. Click on the tab to see the list of forms.
Click on ‘edit’ to display and change the form or on ‘view’ to open the form in read-only mode.
Incomplete and complete forms can be deleted if necessary.

25. Approve and send a complete e-CRF (1)
The Data Manager or research nurse can complete the e-CRFs, but might not be allowed to approve and send them (cfr. delegation of tasks on Signature Log).
! If you are not allowed to approve & send e-CRFs, make sure that you inform the principal investigator or sub-investigator that some forms are ready to be sent !

26. Approve and send a complete e-CRF (2)
Persons authorized to approve and send e-CRF will be able to select the forms they whish to approve and send them.
Enter your password and click on ‘approve & send’.

27. View a sent e-CRF
The number of sent forms you are allowed to view is displayed. Click on the tab ‘Sent’ to see the list of sent forms.
Click on ‘view’ next to the e-CRF to view the form (read-only, no changes can be made). The color-code reflects the status of the form in the EORTC database.

28. Save a CRF to PDF Forms can be saved as PDF document To do this:
Open the form in view-mode
Click on save as PDF
Pick up the PDF
PDF document is displayed and can be printed or saved

29. Queries (1)
After sending data, the CRF will be verified by the EORTC Data Manager.
In case of missing data or inconsistencies, queries will be generated.
In the past, queries were sent to the investigator by in PDF format  print, answer & send back
For trials using ‘electronic’ queries, the queries are displayed in Vista RDC  regularly check if queries were issued (EORTC DM will also inform you by )

30. Queries (2)
In the tab ‘Queries’, all forms with queries that were not yet answered/sent are displayed.
Click on ‘edit’ to see the queries.
Queries not yet answered
Queries answered not yet sent

31. Answer queries 3. save 1. answer query (new value or comment)
2. if applicable, mark query as ‘Ready to send’

32. Query warning checks
New value
Confirm the new value

33. Send answered queries
Persons authorized to approve and send e-CRF, can also send answered queries
2. ‘Approve & send’.
All queries in the column ready to be sent will be sent
1. Enter your ORTA/RDC password

34. Data Correction
Data Correction: request to change data that were already sent to EORTC study database
In the past: data correction form (paper)
For trials using ‘electronic’ queries  can be requested in Vista RDC
Correct / clarify data on the form
Correct patient data

35. Correct / clarify data on a form (1)
A request for data correction can be created on forms that have been sent
Select the form in the tab ‘Sent’
Create the data correction
Send the data correction in the tab ‘Queries’ by entering your username and clicking on the ‘Approve & send’ button
The EORTC DM will modify the database

36. Correct / clarify data on a form (2)
A comment about a form can be created in the same way by clicking on ‘Form comment’ in the header of the e-CRF

37. Data Correction: Correct patient data
Example: date of birth wrong
Tab Queries – section ‘Other queries’ – click on ‘Correct patient data’
To send the request for correction of patient data, enter your password & click the ‘Approve & Send’ button

38. Request for help
If you encounter a technical problem, contact the EORTC webmaster
For protocol related questions, contact the EORTC Data Manager