MINDACT Investigator`s Meeting Sat 16th - Vista RDC

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VISTA RDC
rdc.eortc.be
EORTC Remote Data Capture System
For monitors working on trials with 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
• …
RDC monitoring
• Monitors can create electronic CRA queries and can
electronically tick forms as source data verified
• The CRA queries are raised by the Monitor, should be
answered by the Principal Investigator (or an authorized staff
member) and once answered will be closed by the EORTC
Data Manager
• Source data verification by the Monitor can be done on
'complete' and 'sent' forms and CRA queries can be created
on forms with the same status which are not yet ticked as
'source data verified'
Log-In page
http://rdc.eortc.be
• Documentation
• Account
• study / patients
• ‘Monitor’ rights (RDC access request form)
• 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 queries
• nb of patients waiting monitoring
Click on the blue text to display the list of
these patients
Select a patient
OR
CRF status
• Blank tab: contains for the site the forms to be completed
 No information as not applicable for the monitor
• Incomplete tab: forms with status ‘incomplete’ (not final yet)
 Can be viewed by the monitor
• Complete tab: forms ready to be sent by the site
• Sent tab: forms sent by the site
 Source data verification
 Create CRA queries in case of inconsistencies
Monitoring status
• Not done: source data verification by the Monitor is not done
• Done: source data verification by the Monitor is done
• Queries: number of (un) answered queries
• By clicking on 'not done', 'done' or 'queries' in the monitoring
column, a form can be source data verified and CRA queries
can be created
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
Source data verification
• Click on ‘not done’ in the monitoring column (‘complete’ or
‘sent’ tab)
• All the answers should be verified against the source data. If
there are no discrepancies, the form can be ticked as 'source
data verified' (SDV)
• In case of discrepancies with the source data, a CRA query
should be created
CRA queries (1)
• A CRA query can be created on each field of each form with
status 'complete' or 'incomplete' which is not yet ticked as
'source data verified'
CRA queries (2)
• The query question should be typed in the 'question' field and
should be saved
• The CRA query is automatically sent to the principal
investigator (or an authorized staff member), but can still be
deleted in case of mistakes
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
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