Siebel Clinical Trial Management System Guide > Managing Clinical Trial Sites and Clinical Contacts >
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
- Navigate to the Site Management screen, then the Protocol Site List view.
- In the Sites list, drill down on the Site # of the site for which you want to track documentation.
- Click the Document Tracking view tab.
A list of documents associated with the clinical trial appear.
- Query for the document of interest and complete the necessary fields.
Some fields are described in the following table.
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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
- Navigate to the Site Management screen, then the Protocol Site List view.
- In the Sites list, drill down on the Site # of the site for which you want to track documentation.
- Click the Document Tracking view tab.
A list of documents associated with the clinical trial appears.
- Create a new record and complete the necessary fields.
- Step off the record you have just added and drill down on the Name hyperlink.
The Attachment view appears.
- Create a new record and in the Name field specify the file name or URL.
- 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.
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