1. VISTA RDC rdc.eortc.be EORTC Remote Data Capture System For trials that started before 01/01/2009

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 List of « your » patients appears automatically after study selection Move to the next / previous page (25 pts per page) 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 Click on the blue text to display the list of these patients

9. Select a patient 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 Form nb Form name Reason why form is requested The form can be created by clicking on ‘create’ 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’. 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 6 is requested, but cycle 6 was not given.

13. 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) Create an e-CRF – Other forms Select the form you would like to create by clicking on ‘create’ All CRFs remaining available for completion are displayed in the section ‘other forms’.

14. Complete the e-CRF Enter the data by typing or by selecting the value from the drop-down menu

15. 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. Save a form as incomplete

16. 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 mentioning the mandatory fields that you still need to complete Save a form as complete

17. Pop-up messages will warn you in case a value is out of range. If the value is wrong, you can change it (click Cancel to close the message) If it is correct, you can force the value (please check carefully before forcing, otherwise queries will be raised ) Warning - value out or range

18. Pop-up messages will warn you in case a wrong data format has been used. Please correct the value, using the format as requested in the error message. Warning - incorrect number format

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

20. 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. Edit or view an incomplete or complete e-CRF modify read-only

21. 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). Approve and send a complete e-CRF (1) ! 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 !

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

23. 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. View a sent e-CRF

24. Request for help If you encounter a technical problem, contact the EORTC webmaster (rdc@eortc.be)rdc@eortc.be For protocol related questions, contact the EORTC Data Manager