Difference between revisions of "Talk:QIBA Profile Stages"

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-TODO
-Add statistical criteria (thanks Nancy)
-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.
-*An outline of an approach is described for testing 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).
-Consensus:
-*Requirement specifications include requirements and assessment procedures for the statistical assumptions underlying the Profile Claims (e.g. assessment procedure includes sample sizes, details of phantoms and data collection methods, metric computation, requirement specified thresholds).
-Technically Confirmed:
-*All Profile procedures and requirements have been performed/checked on at least two vendor platforms and at two or more sites and found to be clear and not burdensome/impractical.
-*At least one of each Profile actor have demonstrated conformance (met all requirements).
-*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.

Difference between revisions of "Talk:QIBA Profile Stages"

Latest revision as of 22:07, 16 November 2016

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