Tracking Case Report Forms

This topic describes how to create a CRF (case report form) tracking activity. You capture relevant information, such as review date and page numbers verified, for each CRF record.

To track case report forms

  1. Navigate to the Site Visits screen, then the Clinical Site Visits List view.

  2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track case report forms.

  3. Navigate to the Case Report Forms Tracking view.

  4. To add case report forms for scheduled subject visits, complete the following steps:

    1. Click Add Scheduled.

    2. Select the subject visits in the dialog box that appears.

    3. Click OK.

    The case report forms for selected subject visits appear in the Case Report Forms Tracking view.

  5. To add case report forms for unscheduled subject visits, complete the following steps:

    1. Click Add Unscheduled.

    2. Select the subject visits in the dialog box that appears.

    3. Click OK.

    The case report forms for selected subject visits appear in the Case Report Forms Tracking view.

  6. In the case report forms, complete the necessary fields as shown in the following table.

    Field

    Comments

    Source Verified

    Select this field when you verify the CRF against the source document.

    Retrieved

    Select this field when you retrieve the CRFs from the site.

    Page Numbers Verified

    Type the CRF page numbers that you verify.

    Charts Reviewed Date

    Select the date and time that you review the clinical charts.

    Forms Signed Date

    Select the date and time that you sign the CRFs.