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	Meaning
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 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.

Stage 1: Public Comment

Meaning:

Criteria: