Tracking Case Report Forms
Users can track CRFs (case report forms) as part of a protocol, site, and region. They capture relevant information for each CRF record within a protocol, site and region. This information includes whether the CRFs are source verified, retrieved from a site, received in-house, or received by a data management process.
When you apply a subject visit template, in addition to creating subject visit records and the child activity records that exist in the current product, a duplicate set of visit records with a Type of Case Report Form are created (with the number of pages that the template specifies). These visit records with the number of CRF pages appear in the CRF Tracking view in the Protocol Site List view of the Site Management screen.
This task is a step in Process of Managing Sites and Contacts for Clinical Trials.
To track case report forms
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to track CRFs.
Navigate to the CRF Tracking view
In the CRF Tracking list, complete the necessary fields as shown in the following table.
Field
Comments
Activity
Select the activity associated with the site.
Activity Type
Displays the activity type for the CRF. Only activity records with this activity type appear in this view.
# CRF Pages
Type the number of pages in the CRF.
Retrieved
Select this field if the CRF is retrieved.
Retrieved Date
Select the date and time that the CRF is retrieved.
Received in House
Select the date and time that the CRA (clinical research associate) receives the CRF in house.
Received by Data Management
Select the date and time that a data management process receives the CRF.
Source Verified
Select this field if the CRF is a verified source document.
Source Verified Date
Select the date and time that the CRF is source verified.
Comments
Type relevant comments about the CRF.