Draft policy: labelling of Institute-constructed programme records
Consultation on how the Institute should label a programme record it has constructed by grouping trials, as distinct from a programme as defined by its sponsor. The draft proposes a standing notice on every constructed record stating who constructed it and on…
§1Consultation and window
§1.1Window
- Opened
- 1 November 2024
- Closed
- 1 December 2024
- Duration
- 30 days
- Status
- Closed — the disposition is published
- Document under consultation
- Governance document
- Submissions received
- 13
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is a standing notice sufficient, or should a constructed record be visually distinguished from a sponsor-defined one throughout?
- Should the Institute publish its grouping criteria in full, including the cases where a trial was considered and excluded from a programme?
- Does the draft state clearly enough that a constructed programme record is a finding aid and not a sponsor document?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The policy was ratified with amendments. Constructed records now carry both the standing notice and a distinct visual treatment, and the grouping criteria are published with the trials considered and excluded.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.