Draft format of the supplier dossier series — submissions
The 10 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
10 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
A superseded version should remain reachable from the version that replaced it
The respondent states that the draft supersedes an earlier document and that a reader who cited the earlier version has no way to reach it from the new one, which makes it impossible to see what changed.
The respondent asks that every version carry a link both to what it supersedes and to what supersedes it.
The secretariat notes this submission. The corrections and versioning policy already requires bidirectional version links and every superseded document is retained at its own address.
No amendment arises. The requirement is stated in the corrections and versioning policy and the amendment log of this document links to the version it replaced. The respondent is correct that the link was absent from the draft page furnished for consultation, which was a defect of the consultation copy and not of the policy.
A withdrawn document should not simply disappear
The respondent states that a reader arriving from an external citation at a withdrawn document needs to know that it existed, that it was withdrawn and why, and that a redirect to an index gives none of that.
The respondent proposes a notice at the original address.
The secretariat accepts this submission. A silent removal makes the citation that led there unresolvable.
A withdrawn document is now replaced at its own address by a notice recording its identifier, its title, the date and ground of withdrawal, and a link to whatever supersedes it, and the withdrawal is recorded in the corrections log.
Declared interests should appear on the document rather than on a separate page
The draft links to a central conflicts register. The respondent argues that a reader assessing whether to rely on a particular document should not have to leave it to find out who assessed it and what they declared.
The respondent proposes that the interests of every named contributor to a document be printed on that document.
The secretariat notes this submission and records that the draft already provides for it, which the respondent could reasonably have missed because the provision sits in an appendix.
Every document carries the declared interests of its named contributors in its front matter, and the central register exists so that a reader can see a person across all documents rather than one at a time. No amendment arises; the provision has been moved from the appendix into the body of the methodology document so that it is findable.
The document should not describe uses outside the approved indication
The submission is made on behalf of a marketing-authorisation holder. It states that the draft describes uses of the compound that fall outside the approved indication, that such uses are not supported by the sponsor, and that describing them may be read as legitimising them.
The sponsor asks that the sections concerned be removed, or in the alternative that they carry a prominent statement that the sponsor does not support such use.
The secretariat does not accept this submission. The Institute records what is supplied and what is used, because a reader encountering a compound outside a regulated route is the reader most in need of an assessment of the evidence for it.
The sections remain. Every such section already states the regulatory status of the use described and states that the evidence for it is assessed separately from the evidence for the approved indication. The submission is published in full and identified as an industry submission.
Quantitative claims are reproduced without the method that produced them
Several figures in the draft are quoted from sources that determined them by different methods. A figure obtained by one determination and a figure obtained by another are not comparable, and the draft places them in the same sentence without distinguishing them.
The respondent, an analytical chemist, proposes that every quantitative claim carry the method that produced it at the point of use rather than in the reference.
The secretariat accepts this submission. Placing two figures side by side is an implicit claim that they are the same kind of quantity, and in the cases identified they were not.
Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
The front matter delays the reader from reaching the assessment
The respondent states that a reader must pass through identifiers, dates, contributor lists and declarations before reaching any content, and that the most important sentence in the document is the furthest from the top.
The respondent proposes that the front matter be moved to the end.
The secretariat accepts this submission in part. The assessment statement is moved to the top. The front matter is not moved to the end, because it is what allows the assessment to be checked and a document whose provenance is at the bottom will be quoted without it.
Every document now opens with its assessment statement and its certainty rating, with the identifiers, dates and declarations following immediately beneath rather than above, so that the first thing read is the finding and the second is its provenance.
A multi-part document does not indicate how many parts it has
The respondent states that a reader landing on part two of a document from a search result has no indication that parts one and three exist.
The respondent proposes a parts index on every part.
The secretariat notes this submission. Every part already carries the full parts list in the margin, which the respondent may not have seen at a narrow viewport where the margin is collapsed.
No amendment to structure arises. The parts list is now rendered above the body rather than collapsed at narrow viewports, so that it is visible in the setting where the respondent found it absent.
The search date is not on the face of the document
The draft carries a publication date and a review date but not the date on which the evidence was last searched. Those are three different dates and only the third tells a reader how current the assessment is. A document published in one quarter may rest on a search run two quarters earlier, and nothing on the page allows that gap to be measured.
The respondent proposes that the search date be printed adjacent to every certainty rating rather than in the methods section, on the ground that a reader who acts on a rating is unlikely to have read the methods section first.
The secretariat accepts this submission. The distinction between publication, review and search dates is real and the draft did not make it visible where it mattered.
The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
References should carry a persistent identifier for every cited source
Several references in the draft carry a journal, a year and a volume but no persistent identifier. The respondent, who works in a library setting, states that retrieval of such a reference is materially slower and that identifiers should be supplied throughout.
The respondent asks in the alternative that where an identifier exists but is not carried, the omission be explained rather than left as a gap the reader must interpret.
The secretariat accepts the second limb of this submission and declines the first. Identifiers are supplied wherever the Institute holds one. Where the Institute does not hold an identifier it will not supply one, because a reconstructed identifier that resolves to the wrong record is a worse defect than an absent one.
Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
The registry is published only as pages and not in a form that can be processed
The respondent, a graduate student, states that examining the document set as a whole requires extracting fields from rendered pages, and that a structured record would make the registry usable for research about the Institute itself.
The respondent proposes that the registry fields be published in a structured form alongside the pages.
The secretariat accepts this submission. A body that asks others to publish checkable records should publish one.
The registry fields are now emitted in a structured form alongside the rendered pages, carrying the identifier, series, type, version, dates, certainty rating and status for every document, and the structured record is regenerated with the site so that it cannot drift from the pages.
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.