Tracking and Adding Documents at Sites

During 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 appropriate document and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Activity	Displays a value of Document by default.
   Name	Type the name of the document. This field is a hypertext link to the Attachments view.
   Sent Date	Select the date that you send the document to the site.
   Expected Date	Select the date that the site is expected to return the signed document.
   Received Date	Select the date that the site returns the signed document.
   Expiration Date	Select the date that the document expires.
   Assigned To	Select the user ID of person assigned responsibility for the document.
   Lock Assignment	Select this field as necessary. If the activity is locked, then Assignment Manager cannot access it. If it is unlocked, then Assignment Manager can reassign it.

   
   

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 complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Type	Displays the type of attachment.
   Auto Update.	Select this field if you want to automatically update the file during synchronization. Synchronization applies only to local files. If a file is not local, then it is not updated during synchronization.