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.
The Drafting process is still underway.
The Profile is still changing fairly significantly and fairly often.
Few people outside the Biomarker Committee should be using the document except for submitting Public Comments.
The document should have a reference date but is not yet a formal Edition of the Profile. It's a 'Draft' release.
File Name: Profile Name (Draft).YYYYMMDD.doc, e.g. QIBA CTVol (Draft).20150520.doc
Change Tracking is not particularly productive at this stage.
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.
The document needs a reference date but is not yet a formal Edition of the Profile. It's a 'Reviewed' release.
File Name: Profile Name (Reviewed).YYYYMMDD.doc, e.g. QIBA CTVol (Reviewed).20150520.doc
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 and published.
Products and sites may now claim conformance to the Profile. Changes to the Profile risk invalidating conformance statements and the data that technically or clinically confirmed the Profile.
The document is now fixed as a formal Edition of the profile with a Release Year.
File Name: Profile Name (RRRR).doc, e.g. QIBA CTVol (2014).doc
Change Tracking is handled more strictly with the Maintenance Process using Change Proposals.