QIBA Profile Stages

QIBA Profile Stage Descriptions February 2016

Over time QIBA revises draft Profiles, collects information, and becomes increasingly confident of its ability to achieve the stated claim. However QIBA does not want to withhold Profiles until they are "perfect".

Depending on how they intend to use the Profile, some users will find Profiles valuable even with only modest QIBA confidence, while others will count on achieving the claims exactly. Profile stages are intended to communicate the stage of maturity or confidence clearly and allow users to make their own choice about what meets their needs.

Briefly:

Stage 1 Public Comment	The Biomarker Committee experts have drafted the profile and believe it is practical and will achieve the claimed performance.
Stage 2 Consensus	The wider community has read the profile and believe it to be practical and expect it to achieve the claimed performance
Stage 3 Technically Confirmed	Site(s) have performed the profile and found it to be practical and expect it to achieve the claimed performance
Stage 4 Claim Confirmed	Site(s) have performed the profile and found it achieved the claimed performance
Stage 5 Clinically Confirmed	Many sites have performed the profile and demonstrated the claimed performance is widely achievable.

The Criteria are checklist items/metrics/Rules-Of-Thumb the Biomarker Committee considers before publishing a Profile as having reached that stage.

Stage 1: Public Comment

Meaning:

• The Biomarker Committee (BC) finds that the Profile describes the key factors that affect the claim and has proposed recommended procedures that address each/most of the factors.
• The BC reserves the right to make modifications.

Criteria: