Siebel Life Sciences Guide > Managing Sites and Clinical Contacts > End-User Procedures >

Tracking and Adding Documents at Sites

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.
  2. In the Sites list, select the site for which you want to track documentation.
  3. Click the Document Tracking view tab.

    4. A list of documents associated with the clinical trial appear.

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

    5. Some of the fields in a Document Tracking record 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.
  2. In the Sites list, select the site for which you want to track documentation.
  3. Click the Document Tracking view tab.

    4. A list of documents associated with the clinical trial appears.

  4. Add a record and complete the required fields.

    5. Some of the fields in a Document Tracking record are described in Step 2 of To create documentation tracking activities.

  5. Step off the record you have just added and drill down on the Name hyperlink.

    6. The Attachment view appears.

  6. Add a 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.

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


 Siebel Life Sciences Guide 
 Published: 18 April 2003