Siebel CRM Siebel Clinical Trial Management System Guide Siebel Innovation Pack 2016 E52416-01 |
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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
Navigate to the Administration - Clinical screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol for which you want to create a new protocol version.
Navigate to the Protocol Versions view.
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 | 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. |