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Tracking Case Report Forms (CRFs)


Users can create and track CRFs 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 children activities records as existed in the current product, a duplicate set of visit records with Type = Case Report Form are created (with # Pages as specified in the template).

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

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 of the protocol site for which you want to track CRFs.
  3. In the CRF Tracking tab view, click New to create a new record, and complete the necessary fields.

    Some fields are described in the following table.

    Field
    Description

    Activity

    Lists the activities associated with the site.

    Activity Type

    Defaults to CRF activity type. Only activity records with CRF activity type are displayed in this view.

    CRF Pages Number

    The number (#) of pages contained in the CRF.

    Retrieved

    Checked if the CRA 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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