Talk:QIBA Profile Stages

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.
• 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.