1. Clinical Trial Management System Guide
  2. Tracking Case Report Forms for Partial Source Data Verification During Site Visits

Tracking Case Report Forms for Partial Source Data Verification During Site Visits

This topic describes how to track the CRFs (case report forms) for PSDV (partial source data verification) during a site visit. During a site visit, CRAs (clinical research associates) do not review all CRFs and all pages on those CRFs. The field values for PSDV in the subject visit template that is associated with the site visit determine the information that appears in the PSDV fields of CRFs. The CRA restricts the review to the information in these PSDV fields.

To track the case report forms for partial source data verification during a site visit

  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 for partial source data verification.

  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. For a description of the PSDV fields that appear in this view, see Viewing Case Report Forms for Partial Source Data Verification.

  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. For a description of the PSDV fields that appear in this view, see Viewing Case Report Forms for Partial Source Data Verification.

  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.