CRA Reconciliation

This section helps to locate CRA Reconciliation Reports for site visit decisions.

The CRA Reconciliation module in Trial Interactive enables Clinical Research Associates (CRAs) to reconcile documents during site visits. This module helps CRAs verify document completeness, identify missing records, and generate reconciliation reports to support site monitoring decisions. Users need to have the CRA Reconciliation action on their user profile to see this module.

Users can access the CRA Reconciliation module from the navigation grid in the upper-left corner of the screen. While any user can be granted access, only those designated as a CRA for a site can perform reconciliation and reporting functions.

The CRA Reconciliation module has the following sections:

1. Documents: This allows the CRA to mark the documents as verified, missing in eTMF, missing in ISF, or add the placeholder for an expected document as a part of the reconciliation process.
2. Reports: This allows the CRA to create a CRA Report which will include all the documents reviewed by the CRA since the last report created by user.
3. Audit Trail: This is a security-relevant chronological set and source of records that provide evidence of the sequence of activities performed over a document. The changes made in a document by all users are displayed within the Audit Trail.
   
   
   

Note: The user can be granted access to the CRA Reconciliation module but the reconciliation and reporting functions will only be available to users who have been designated as a CRA for a site. This designation is not available to room administrators.