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Creating Documentation Tracking Activities


Numerous documents are collected during clinical trials, either as electronic files or as paper. These documents must be tracked and periodically updated. Documents can be associated with sites, regions, protocols, contacts, or accounts.

To create documentation tracking activities

  1. Navigate to the Document Tracking screen.
  2. In the Document Tracking list, create a new record and complete the necessary fields.

    NOTE:  A document tracking activity can be associated with only one of the available tracking levels or entities.

    Some fields are described in the following table.

    Field
    Comments

    Name

    The document name.

    This is a hyperlink to the associated Attachment view.

    Site, Region, Protocol, Contact, or Account

    Delegate the document to one of these fields. The field you select determines how the hyperlink in the Name field operates.

    This field is a hyperlink to the associated Activities view.

To review, update, and add existing documentation for tracking

  1. Navigate to the Document Tracking screen.
  2. In the Document Tracking list, query for the document you want to update.
  3. Click the document name hyperlink.

    The associated Attachment view appears.

  4. In the Attachment list, query for the document and click the document name.
  5. Open, update, and save the document.
  6. Use the thread bar to return to the document record on the Document Tracking list.
  7. Copy the original document record and revise the associated site, region, protocol, contact, or account field.

Alternatively, documentation tracking activities can be created and reviewed in the Document Tracking view tab for a site. Similarly, document tracking activities at the protocol and region levels can be created and reviewed in the Document Tracking view tab for the protocol and region.

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