Siebel Clinical Trial Management System Guide > Setting Up Clinical Trials >

Creating and Revising Versions for Clinical Protocols

Protocol versions can be tracked and managed using Siebel Clinical. The study manager can create a tracking record for the original protocol as well as for each subsequent version.

This task is a step in Process of Managing Clinical Trials.

To create a version for a clinical protocol

1. Navigate to the Administration - Clinical screen, then the Protocol List view.
2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to create a new protocol version.
3. Navigate to the Protocol Versions view.
4. In the Protocol Versions list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Original Version	If this is the first version of the protocol, then check this field. If this field is checked, then the Amendment Version field becomes read-only.
   Amendment Version	The version number of the protocol version. For example, Version 1, Version 2, and so on.
   Date	The date on which the new version was approved.