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

Creating Tracking Activities for Case Report Forms

Numerous CRFs (case report forms) are collected during clinical trials, either as electronic files or as paper. These forms must be tracked and periodically updated. CRFs can be associated with sites, regions, or protocols.

CRF tracking records are created when you apply a subject visit template in addition to subject visit records. You can also create an activity for CRF tracking from the CRF Tracking View of a site.

This task is a step in Process of Managing Sites and Contacts for Clinical Trials.

Viewing Tracking Activities for Case Report Forms

Complete the procedure in this topic to view tracking activities for CRFs (case report forms).

To view tracking activities for a case report form

• Navigate to the Document Tracking screen, then the CRF Tracking view.

  The CRF Tracking list displays all of the tracking records.

  NOTE:  A tracking activity for a CRF can be associated with only one of the available tracking levels or entities.

  Some fields are described in the following table.

  Field	Comments
  Name	The name of the subject visit for which CRFs were collected.
  Site #, Region, or Protocol #	CRF tracking can be assigned to the site, region, or protocol.

Reviewing, Updating, and Adding Existing Case Report Forms for Tracking

Complete the procedure in this topic to review, update, and add existing CRFs (case report forms) for tracking.

To review, update, and add existing case report forms for tracking

1. Navigate to the Document Tracking screen, then the CRF Tracking view.
2. In the CRF Tracking list, query for the document you want to update.
3. Open, update, and save the CRF.
4. Use the thread bar to return to the CRF record on the CRF Tracking list.
5. Copy the original CRF record, and revise the associated site number, Region, and protocol number field.

Alternatively, you can create and review activities for CRF tracking from the CRF Tracking view of a site. Similarly, at the protocol and region levels, you can also create and review activities for CRF tracking from the CRF Tracking view.