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

Tracking and Adding Documents at Sites

During the life of a clinical trial, CRAs (clinical research associates) collect and track numerous documents, including critical regulatory documents. CRAs can take advantage of the activity plans to generate a list of documents for tracking. In the document tracking views, they can also create their own lists of activities to track important dates.

NOTE:  Regional study managers can use similar procedures to add and track documents at the region level in the Regions screen.

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

Tracking Documentation Milestones

Complete the procedure in this topic to track documentation milestones.

To track documentation milestones

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 documentation.
3. Navigate to the Document Tracking view.

   A list of documents associated with the clinical trial appears.

4. Query for the document of interest and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Activity	By default, the activity is Document.
   Assigned To	The person to whom responsibility for the document has been assigned.
   Expected Date	The date that the signed document is expected to come back from the site.
   Expiration Date	The date the document expires.
   Lock Assignment	Determine whether to select the Lock Assignment field. If the activity is locked, then Assignment Manager cannot access it. If it is unlocked, then Assignment Manager can reassign it.
   Name	The name of the document. This field is a hypertext link to the Attachments view.
   Received Date	The date that the signed document returns from the site.
   Sent Date	The date that the document is sent to the site.

Adding Documents to Sites

Complete the procedure in this topic to add a document to a site.

To add a document to a site

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 documentation.
3. Navigate to the Document Tracking view.

   A list of documents associated with the clinical trial appears.

4. Create a new record and complete the necessary fields.
5. Step off the record you just added and drill down on the Name field.

   The Attachments view appears.

6. Create a new record and in the Name field specify the file name or URL.
7. Select the Auto Update field if you want to have the file automatically updated during synchronization.

   Synchronization applies only to local files. If a file is not local, then it cannot be updated during synchronization.