Talk:QIBA Profile Stages

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:

• At least one site has performed and successfully met the conformance criteria for the statistical assumptions underlying the Profile claims (e.g. studies were conducted to assess linearity and estimate bias and precision, and these met the conformance criteria stated in the Profile).

Claim Confirmed:

• Biomarker measurements collected from at least one site meet all the Profile claims.