Profile Requirements tell Vendors and Site Staff what they must do to claim conformance with the Profile.
And the point of conformance to a Profile is to achieve the technical performance stated in the Claim,
So, Each requirement in a Profile should meet three criteria:
- It has a discernable impact on the performance of the biomarker (Impact Criteria)
- It is violated often enough in practice to be worth addressing (Violation Criteria)
- The impact exceeds the effort it takes to conform (Cost-Benefit Criteria)
Every requirement that fails one of the above criteria consumes time and attention unnecessarily at every conforming site. Some also consume tangible effort and resources. Having Too Many Requirements is an issue with almost every Profile. Every extra requirement potentially discourages more sites from conforming. Dropping requirements is a key mission once the initial brainstorming is done.
The requirement should have a discernable impact on the performance of the biomarker since that is the ultimate purpose of a Profile.
The Biomarker Committee should be able to state, for each requirement, the way it impacts the Claim.
TODO Link to Stage 0 Groundwork, Stage 1 feedback, etc.
The requirement should be violated often enough in practice to be worth addressing.
As with the Impact Criteria, requirements that fail the Violation Criteria should be easy to drop.
TODO Link to Stage 1 feedback, Stage 0 brainstorming, etc.
TODO Link to Stage 3 Tech Conf, Stage 1 feedback, etc.
What exactly are you asking me to do?
Is it clear whether I've passed?