(Page under revision by Process Cmte during 2021.03)
QIBA ZZZZZ Profile (YYYY)
A Technically Confirmed or Claim Confirmed Profile is a stable specification to which products and sites can claim conformance.
The published Profile captures trade-off choices between what requirements were considered reasonably achievable and what performance is useful/acceptable.
Those choices, however, represent a snapshot at a particular point in time.
As the underlying biomarker is adopted, performance expectations may increase, for example to meet the needs of a new clinical application, and new technologies may become more widely available in the installed base, making it practical to add them to the conformance requirements.
Making such changes to the Claim or Requirements of an existing edition of a Profile would invalidate published Conformance Statements.
We can, however, publish a new edition of the Profile, which documents the same biomarker but with revisions to the claim and requirements.
TODO Consider working the Stage in. e.g. 2020 Stage:2. Also should we also incorporate versioning 3.1. Work up the use cases - publication, conformance, document change tracking, etc.
What if groups update within one year? 2020 -> 2020A? Agree we need to have a mechanism.
Is it a good thing if our "stable specification" are changing multiple times a year?
Using MRE as an example, what about changes that are not normative changes?
- This product conforms to the Tech Confirmed QIBA XXX Profile (2020) vs Claim Confirmed QIBA XXXX Profile (2020)
- This product conforms to the Tech Confirmed QIBA XXX Profile V3.1 2020.09.22 vs Claim Confirmed QIBA XXX Profile V3.2 2020.12.22
"Significant differences" = changes in the conformance requirements pass thresholds or the assessment procedures; biomarker is the same,
- Different biomarker (2D->3D)
- Different anatomy
- Different values (refined) in performance claim
- Q. When is a separate profile warranted?
- Q. Can someone claim conformance for the Profile in one piece of anatomy but not others?
The QIBA ZZZZZ Profile (2013), which represents what was considered reasonable performance in 2013, can be published alongside QIBA ZZZZZ Profile (2015), which reflects the emergence and adoption of newer technologies that provide a significant and useful improvement in performance. Although some sites and products might still only be able to claim conformance to QIBA ZZZZZ Profile (2013), we still know what level they are operating on.
Note that additional field testing might be needed before the revised edition could be considered Technically or Clinically Confirmed.