Difference between revisions of "Requirements Guidance"

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(Created page with "{{TOCright}} 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...")
 
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Profile Requirements '''tell Vendors and Site Staff what they must do''' to claim conformance with the Profile.
 
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.
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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''':
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So, Each requirement in a Profile should meet '''three criteria''':
 
:* It has a discernable '''impact on the performance''' of the biomarker (Impact 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)
 
:* 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)
 
:* The '''impact exceeds the effort''' it takes to conform (Cost-Benefit Criteria)
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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.
  
 
===Impact 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.
 
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.
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The Biomarker Committee should be able to state, for each requirement, the way it impacts the Claim.  
 
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Corollary: For each requirement, the Biomarker Committee should be able to state   
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TODO Link to Stage 0 Groundwork, Stage 1 feedback, etc.
 
TODO Link to Stage 0 Groundwork, Stage 1 feedback, etc.

Revision as of 22:16, 24 September 2021

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.

Impact Criteria

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.


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?