Public comment period · §3
Draft synthesis: Completeness of certificates of analysis in… — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-COA-COMPLETE/007 | Dr Jerome Petrossian | A funnel plot is presented for a set too small to interpret it | Accepted |
| DRAFT-COA-COMPLETE/008 | Dr Theodora Ximenes industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-COA-COMPLETE/005 | Dr Quintus Kettlewell | The document is unreadable without specialist training | Accepted in part |
| DRAFT-COA-COMPLETE/006 | Dr Theodora Ingelbrecht | Baseline imbalance in a small contributing trial is not remarked on | Noted, no amendment |
| DRAFT-COA-COMPLETE/004 | Dr Ottoline Oppenheimer-Ade | The review protocol is described but its registration record is not linked | Accepted in part |
| DRAFT-COA-COMPLETE/003 | Dr Hortensia Larsson-Ekwueme | Analytical surveys are treated as evidence about suppliers when they establish only what was in a sample | Accepted |
| DRAFT-COA-COMPLETE/002 | Dr Quentin Whitmarsh-Obi | Risk-of-bias judgements are reported as an overall rating without the domains | Accepted |
| DRAFT-COA-COMPLETE/001 | Dr Delphine Trelawney | The review does not say when it will be updated or what would trigger an update | Accepted |
| 8 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 4 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 3 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 0 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- A funnel plot is presented for a set too small to interpret it — arising from DRAFT-COA-COMPLETE/007. The funnel plot is removed for every outcome contributed by fewer than ten studies, and replaced by a statement that small-study effects could not be assessed at that number, together with the count of registered trials identified without posted results.
- A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-COA-COMPLETE/008. The trial is added to the included set, the estimate and the certainty rating have been recomputed, and the screening record now states why the trial was missed, which was a database indexing gap rather than a screening judgement. The submission is identified…
- The document is unreadable without specialist training — arising from DRAFT-COA-COMPLETE/005. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
- The review protocol is described but its registration record is not linked — arising from DRAFT-COA-COMPLETE/004. Each synthesis now links its own protocol with the version in force at screening, and states explicitly where an external registration identifier is not held, so that the absence is a recorded fact.
- Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-COA-COMPLETE/003. Provenance is now assessed for every included survey and reported as a study characteristic, surveys without establishable provenance are reported separately rather than pooled with those that have it, and no supplier-level inference is drawn from a…
- Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-COA-COMPLETE/002. Risk of bias is now reported at domain level for every included study, with the text on which each judgement was based quoted and referenced, and the overall judgement derived from the domains rather than asserted alongside them.
- The review does not say when it will be updated or what would trigger an update — arising from DRAFT-COA-COMPLETE/001. Every synthesis now records a scheduled review date and a stated update trigger, being the reporting of a trial that would materially change the contributing evidence, and the registered trials capable of triggering an update are listed by name.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-105/3 · https://compoundevidence.com/comment-periods/draft-coa-completeness-research-supply-synthesis/disposition/ · retrieved 30 July 2026