Siebel Clinical Trial Management System Guide > Managing Sites and Contacts for Clinical Trials >

Tracking Case Report Forms


Users can create and track CRFs (case report forms) as part of a protocol, site, and region. Relevant information, such as whether the CRFs are source verified, retrieved from a site, in-house, or by a data management process, is captured for each CRF record within a protocol, site and region.

When you apply a subject visit template, in addition to creating subject visit records and the child activity records as existed in the current product, a duplicate set of visit records with a Type of Case Report Form are created (with the number of pages specified in the template).

These visit records with the number of CRF pages are listed in the CRF Tracking view in the Protocol Site List view of the Site Management screen. You can also create records for CRF tracking in this view.

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, create a new record and complete the necessary fields.

    Some fields are described in the following table.

    Field
    Comments

    Activity

    Lists the activities associated with the site.

    Activity Type

    Populated with the CRF activity type. Only activity records with the CRF activity type appear in this view.

    # CRF Pages

    The number of pages contained in the CRF.

    Retrieved

    Checked if the CRA (clinical research associate) was retrieved by Data Management.

    Retrieved Date

    Date when the CRF was retrieved.

    Received in House

    Date when the CRA retrieved the CRF in house.

    Received by Data Management

    Date when the CRA retrieved the CRF by data management.

    Source Verified Date

    The date when the CRF was source verified.

    Comments

    Enter a relevant comment about the CRF.

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