Data Review configuration
1. Configure global roles
Configure which roles will be capable to access and use the options Data Review options .
Steps to configure Data Review permissions :
Navigate to "Platform Settings" > "Roles"
Identify and open the role to configure
Select "Edit"
Open the permission bloc "eCRF"
Configure the permission "Monitoring"
This permission will display the dashboard
Configure the permissions " Review" and "Verify Source Data"
These permissions allow a user to perform the "Review" and/or SDV actions under a CRF
Save
Repeat this operation for each role who must access the options
2. Activate review option for a clinical study
Since all organization or Clinical studies required to use these options ,by default, Data Review and Source Data Verification (SDV) are deactivated options. In order to activate the option, a user having an access to study settings must configure the option.
Steps to activate Data Review :
Search and access the EDC clinical study,
Navigate to "Settings" > Option
Select "Edit"
Activate the option "eCRF Review"
Save
At this point, a new dashboard is now visible under the page eCRF > Monitoring and the associated options are now available under the eCRF subject data collection forms.
Data Review actions
1. Use form data review
A user having the associated permissions can mark a from as reviewed (quality stamp) and see the Monitoring Dashboards.
Steps to apply a from Data Review Stamp :
Search and access the EDC clinical study,
Open the subject's eCRF to review,
Navigate to the appropriate page,
Review the information,
Apply "Reviewed" stamp using the logo
Applying the review will mark the from as Reviewed on "Date" by "User"
Notes :
Any data change under the page will remove the "Reviewed by Stamp".
The Review stamp is applied at the subsection level.
The review action can be used for any purpose on the application, depending on the clinical project organization. There is no side impact to know, other than "page is reviewed"
Steps to use Data Review Dashboard:
Open the page "Monitoring",
Select the tab " Data Review",
Use filters and search options to look for a specific subject or subsection,
Check the details :
each row is an eCRF to review,
the progression is the % of subsection reviewed under the eCRF
Quickly navigate to an eCRF using the logo
Review forms, use back to continue reviewing the next eCRF
2. Use Source Data Verification (SDV)
A user having the associated permissions can mark a data point as SDV and see the Monitoring Dashboards.
Steps to mark a data as SDV :
Open an eCRF,
Navigate to the form to review,
Check the visible data, compare to the source
If the data is compliante, select more option using the logo
Select "Add SDV"
Move to next data
Tips :
It is possible to add a bulk SDV, using the logo on top of the form
Steps to use Source Data Verification Dashboard:
Open the page "Monitoring",
Select the tab " Source Data Verification",
Use filters and search options,
Check the details :
each row is an eCRF question,
the progression is the % of [SDV questions] / [total visible questions] under all eCRF accessible for the user
Quickly navigate to an eCRF question using the logo
Review forms, use back to continue reviewing