CRA Reconciliation

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

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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.

Document Reconciliation

The Document Reconciliation section provides a structured interface for managing, tracking, and organizing documents associated with various events. It allows users to efficiently apply filters to view the index location of document related activities within folders.

Users can access Document Reconciliation by selecting Documents in the left-side navigation pane. In the View Documents By section, users can choose a view based on their reconciliation requirements.

In the View Documents By filter, users can select a view for a documents review based on requirements.

To apply View Documents By filter, follow these steps:

  1. Navigate to the Documents section from the CRA Reconciliation module, at the top of the Index pane, click the View Document By dropdown menu.
  2. This dropdown menu allows users to choose how they want to view the documents.
  3. Select the available documents view: eTMF Completeness.
  4. Based on user requirements, select one of the options from View options.
  5. If the user needs to review, the user has the option to make their selection the default view:
    • Set Default: this will set the selected view as the default for the current session.
    • Set Default for All Rooms: this will make the selection the default for all rooms, not just the current one.


  6. After selecting the view documents by options, click Select to apply the changes, these changes will reflect at the top of the Index pane, or click the Cancel button to discard the changes.
  7. After applying the selection from View Document by options, the user can see the folder, based on the selections.