VISTA RDC
rdc.eortc.be
EORTC Remote Data Capture System
For trials with electronic queries and RDC monitoring
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
RDC is not used for …
• Patient registration
• Reporting SAE
• QoL forms
• …
Log-In page
http://rdc.eortc.be
• Documentation
• Request username & password
• Account
• study / patients
• complete and/or sign (documented on the signature log)
• Login
Main page
Study box contains
« your » studies
List of patients
List of « your » patients
appears automatically after
study selection
Move to the next / previous page
(25 pts per page)
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
Select a patient
Open the patient ‘file’ by
entering the seqID
Or open the patient ‘file’ by
clicking on a patient
Create an e-CRF – tab ‘Blank’
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.
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.
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
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)
Completing an e-CRF – types of data
Numeric field
Label field
Date field
Text field
Completing an e-CRF – assistance
Form instructions
Help function
Label instructions
Field instructions
Comment fields
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
Completing an e-CRF – collapsibles (2)
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
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
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.
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
Cancel - Delete
If you do not want to save your changes, click ‘Cancel’
If you want to erase a form, click ‘Delete’
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.
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 !
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’.
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.
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
Queries (1)
• After sending data, the CRF will be verified by the EORTC Data
Manager.
• In case of missing data or inconsistencies, DM queries will be
generated.
• In the past, queries were sent to the investigator by e-mail 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 e-mail)
• During the source data verification, the monitor can also
create CRA queries (on ‘complete’ and ‘sent’ forms) in case of
inconsistencies.
Queries (2)
• In the tab ‘Queries’, all forms with queries that were not yet
answered/sent are displayed.
Queries not
• Click on ‘edit’ to see the queries.
yet answered
1
Queries answered
not yet sent
Queries (3)
• Unanswered CRA queries can also be accessed and answered
from the 'complete' or 'sent' tab by clicking on 'queries':
Answer queries
3. save
1. answer query (new value or comment)
2. if applicable, mark query as ‘Ready to send’
Query warning checks
• New value
• Confirm the new value
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
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
Correct / clarify data on a form (1)
A request for data correction can be created on forms that have
been sent
1.
2.
Select the form in the tab ‘Sent’
Create the data correction
3.
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
4.
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
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
Source data verification
• The monitor will indicate ‘complete’ or ‘sent’ forms that are
source data verified as ‘SDV done’.
• The status of the monitoring is shown in the monitoring
column in the ‘complete’ and the ‘sent’ tab
Request for help
• If you encounter a technical problem, contact the EORTC
webmaster (rdc@eortc.be)
• For protocol related questions, contact the EORTC Data
Manager