Change Tracking and File Naming
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Change Tracking processes and File Naming conventions are driven by the stability and acceptable usage of the Profile at each stage.
Drafting Stage
The Profile is still changing fairly significantly and fairly often.
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.
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.
Changes go through the Change Proposal Process.