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Tracking and Adding Documents at Sites (End User)

During the life of a clinical trial, CRAs need to 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.

To track documentation milestones

1. Navigate to the Site Management screen > Protocol Site List view.
2. In the Sites list, drill down on the Site # of the site for which you want to track documentation.
3. Click the Document Tracking view tab.

   A list of documents associated with the clinical trial appear.

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 the Lock Assignment field should be selected. If the activity is locked, Assignment Manager will not access it. If it is unlocked, Assignment Manager can reassign it.
   Name	The name of the document. This field is a hypertext link to the Attachments tab.
   Received Date	The date that the signed document returns from the site.
   Sent Date	The date that the document is sent to the site.

To add a document to a site

1. Navigate to the Site Management screen > Protocol Site List view.
2. In the Sites list, drill down on the Site # of the site for which you want to track documentation.
3. Click the Document Tracking view tab.

   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 have just added and drill down on the Name hyperlink.

   The Attachment view appears.

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

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