RDC with paper queries_Feb 2014 - Vista RDC

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VISTA RDC
rdc.eortc.be
EORTC Remote Data Capture System
For trials that started before 01/01/2009
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
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 nb
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 6 is requested, but cycle 6 was not given.
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)
Complete the e-CRF
Enter the data by typing or by
selecting the value from the
drop-down menu
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
mentioning the mandatory fields that you still need to complete
Warning - value out or range
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 - incorrect number format
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.
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.
read-only
modify
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.
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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