Change Tracking and File Naming
Change Tracking processes and File Naming conventions are driven by the stability and acceptable usage of the Profile at each stage.
Drafting Stage
The Drafting process is still underway.
The Profile is still changing fairly significantly and fairly often.
Except for Public Comment, Few people outside
There is no specific Change Tracking.
Publicly Reviewed Stage
The Public Review process has been completed.
The Profile has stabilized somewhat but may still change as additional groundwork projects and field tests are completed.
Clinical Trials might choose to use and/or reference the Profile as a guidance document.
Change Tracking is handled by summarizing significant changes in the Change Log table at the top of the document (See QIBA Profile Template).
Technically Confirmed & Clinically Confirmed Stage
The Technical Confirmation and/or Clinical Confirmation process has been completed.
The Profile is now stable for implementation.
Products and sites may claim conformance to the Profile.
Change Tracking is handled more strictly with the Change Proposal Process.