Requirements Guidance

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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.

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)

Impact Criteria

The requirement should have a discernable impact on the performance of the biomarker since that is the ultimate purpose of a Profile.

Every requirement that fails that criteria consumes time and attention at every conforming site. Some of them also consume effort and resources. Having Too Many Requirements is an issue with almost every Profile. These are easy ones to drop.

Corollary: For each requirement, the Biomarker Committee should be able to state

TODO Link to Stage 0 Groundwork, Stage 1 feedback, etc.


Violation Criteria

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.


Cost-Benefit Criteria

TODO Link to Stage 3 Tech Conf, Stage 1 feedback, etc.

Expressing Requirements

What exactly are you asking me to do?

Is it clear whether I've passed?