Creating and Revising Versions for Clinical Protocols

You can track and manage protocol versions using Siebel Clinical. The study manager can create a tracking record for the original protocol and 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 shown in the following table.

   Field	Comments
   Original Version	Select this field if this version is the first version of the protocol. If this field is checked, then the Amendment Version field is read-only.
   Amendment Version	Select the version number of the protocol version, for example, Version 1, Version 2, and so on.
   Date	Select the date and time that you approve the new version.