Difference between revisions of "Change Tracking and File Naming"
Line 11: | Line 11: | ||
− | File Name: Profile Name (X) | + | File Name: Profile Name (X).YYYYMMDD.doc, e.g. QIBA CTVol (X).20150520.doc |
Change Tracking is not particularly productive at this stage. | Change Tracking is not particularly productive at this stage. | ||
Line 26: | Line 26: | ||
− | File Name: Profile Name (X) | + | File Name: Profile Name (X).YYYYMMDD.doc, e.g. QIBA CTVol (X).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]]). | Change Tracking is handled by summarizing significant changes in the Change Log table at the top of the document (See [[QIBA Profile Template]]). |
Revision as of 03:33, 21 May 2015
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.
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 an 'X' release.
File Name: Profile Name (X).YYYYMMDD.doc, e.g. QIBA CTVol (X).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 an 'X' release.
File Name: Profile Name (X).YYYYMMDD.doc, e.g. QIBA CTVol (X).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 is published as a formal Edition of the profile with a Release Year.
Products and sites may claim conformance to the Profile.
File Name: Profile Name (RRRR).doc, e.g. QIBA CTVol (2014).doc
Change Tracking is handled more strictly with the Change Proposal Process.