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

  1. Navigate to the Site Management screen, then the Protocol Site List view.

  2. In the Protocol Site list, drill down on the site number field of the site for which you want to track CRFs.

  3. Navigate to the CRF Tracking view

  4. 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.