Prior to publishing a Public Comment Profile, a Consensus Profile, a Technically Confirmed Profile, Claim Confirmed Profile or a Clinically Confirmed Profile:
- The review and approval process is the same
- The criteria differ depending on the stage
Remember, this is the QA point. It doesn't have to be perfect. It does have to be good.
Review (Biomarker Committee)
The following review process is strongly recommended, but Biomarker Committees are not required to follow this specific process.
- Authors/Editor of the Profile request content review once they feel work on the current stage has been completed
- Biomarker Committee assigns/recruits reviewers for Profile sections
- Ideally each section should be covered by more than one reviewer
- Reviewing assignments can be divided up any way that is convenient
- It is helpful to have some reviewers read through the profile in its entirety (finds inconsistencies/gaps)
- Reviewers check the Profile meets the criteria for the stage as well as general clarity/quality
- A two week window for the reviewers to do their work is suggested
- Reviewers report back to the Biomarker Committee
- The Authors and Biomarker Committee resolve any questions/comments/clarifications raised by the reviewers
Approve (Biomarker Committee)
The main purpose of Biomarker Committee approval is to confirm that all the detailed contents are correct and the profile meets the criteria for the stage.
- The Secretariat circulates a Ballot asking Biomarker Committee members to approve that the content of the Profile meets the criteria for the stage
- Generally the ballot period should be 2-4 weeks to allow time to review the full Profile text
- In the case of approving to publish for Public Comment, it is acceptable to instead hold a vote during a committee meeting.
Approve (Modality Coordinating Committee)
The main purpose of Coordinating Committee approval is to confirm that the profile is hitting the intended mark (e.g. the claim is on target) and to bring fresh eyes to the overall document (it is understandable, unburdensome and likely to be effective).
- The Biomarker Committee provides the details of the ballot (highlighting any unresolved ballot comments) and requests approval to publish from the Coordinating Committee
- Note that some Coordinating Committees only meet once every several months so the Biomarker Committee is advised to check on that to avoid missing a window
- The Coordinating Committee puts the approval question on the agenda for a Vote in committee at an upcoming meeting.
- Since there is a lengthy document involved, the agenda notification should be circulated at least 2 weeks before the meeting.
- The Coordinating Committee may choose to do a ballot if that would be faster than waiting for the next meeting