Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial >

Creating and Revising Protocol Versions

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.

To create a new protocol version

1. Navigate to the Clinical Administration screen > Protocol List view.
2. In the Protocols list, drill down on the Protocol # of the protocol for which you want to create a new protocol version.
3. In the Protocol Versions tab view, 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, check this field. If this field is checked, the Amendment Version field becomes read-only.
   Amedment 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.