Difference between revisions of "Talk:QIBA Profile Stages"

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TODO
 
Add criteria - Statistician has validated the claim language, Claims have been statistically confirmed to level of rigor X
 
  
Public Comment:
 
*Profile claims are written in a statistically correct format (see Claim Guidance document).
 
*The statistical assumptions underlying the Profile claims are listed under the claim statements (e.g. for longitudinal claims, the assumption of linearity and the estimate of the wCV are stated; for cross-sectional claims, the estimate of the bias and precision are stated).
 
*The statistical assumptions underlying the Profile claims have been reviewed by a statistician to ensure that they are sufficient for the claims. 
 
*Recommended: An approach is described for testing the statistical assumptions underlying the Profile Claims (see Consensus Criteria). 
 
 
Consensus:
 
*Requirement specifications include requirements and assessment procedures for the statistical assumptions underlying the Profile Claims (e.g. a phantom study to test linearity and bias of the measurements from image analysis software; a clinical study to test precision of the measurements). 
 
 
Technically Confirmed:
 
*The assessment data from the actor conformance results have been reviewed by a statistician and found to validate the statistical assumptions underlying the claims.
 
 
Claim Confirmed:
 
*Biomarker measurements collected from at least one site meet all the Profile claims.
 

Latest revision as of 22:07, 16 November 2016