Consultation record

Submissions noted, no amendment

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.

Submissions

109 documents · page 1 of 4

Table 1. Submissions with this disposition, on this page.

Reference	Consultation	Respondent	Point raised
DRAFT-CERTAINTY-FR/006	Draft revision of the Institute’s certainty assessment framework…	Dr Lorcan Whitmarsh-Obi	The document should describe how an assessment becomes a decision
DRAFT-SUPPLIER-RUB/002	Draft supplier evaluation rubric	Georgiana Zimmerthal	Declared interests should appear on the document rather than on a separate page
DRAFT-SEMAGLUTIDE-/009	Draft monograph: semaglutide, version 3	Vittoria Ylönen	The monograph should not describe how the compound is supplied outside a regulated route
DRAFT-TIRZEPATIDE-/004	Draft monograph: tirzepatide, version 2	Dr Xenia Nyquist-Obiora	Guidance on lyophilised storage is missing
DRAFT-WEIGHT-REGAI/008	Draft synthesis: weight change after discontinuation of an incretin…	Dr Yaa Kettlewell	Baseline imbalance in a small contributing trial is not remarked on
DRAFT-FUNDING-POLI/004	Draft funding and sponsorship policy	Kamila Ubertini	The Institute publishes no telephone number and no messaging channel
DRAFT-CITATION-POL/007	Draft citation policy	Dr Perpetua Haverkamp-Diallo industry	The disclosure requirements exceed those of comparable bodies
DRAFT-PROGRAMME-RE/004	Draft policy: labelling of Institute-constructed programme records	Kolawole Oppenheimer-Ade	The Institute publishes no telephone number and no messaging channel
DRAFT-ENDOTOXIN-ST/004	Draft standard: bacterial endotoxin testing of peptide presentations	Stellan Cholmondeley-Ade	A superseded version should remain reachable from the version that replaced it
DRAFT-GLP1-OBESITY/015	Draft synthesis: glucagon-like peptide-1 receptor agonists for weight…	Georgiana Zimmerthal	Declared interests should appear on the document rather than on a separate page
DRAFT-THYROID-C-CE/008	Draft safety review: the rodent thyroid C-cell signal and its human…	Dr Yaa Kettlewell	Baseline imbalance in a small contributing trial is not remarked on
DRAFT-THYROID-C-CE/010	Draft safety review: the rodent thyroid C-cell signal and its human…	Dr Emiliana Ollerenshaw	Declared interests should appear on the document rather than on a separate page
DRAFT-SUPPLIER-DOS/005	Draft format of the supplier dossier series	Ulysses Bellingham-Ojo	A multi-part document does not indicate how many parts it has
DRAFT-PEOPLE-REGIS/002	Draft policy on the register of members and reviewers	Dr Beatrijs Hazelrigg	Assessment committee meetings are held in private
DRAFT-PEOPLE-REGIS/006	Draft policy on the register of members and reviewers	Kolawole Oppenheimer-Ade	The Institute publishes no telephone number and no messaging channel
DRAFT-PEOPLE-REGIS/008	Draft policy on the register of members and reviewers	Vittoria Ylönen	Declared interests should appear on the document rather than on a separate page
DRAFT-PEOPLE-REGIS/013	Draft policy on the register of members and reviewers	Wilhelmina Erlingsson	A submission the Institute declines to publish leaves no trace
DRAFT-CORRECTIONS-/007	Draft corrections and versioning policy	Georgiana Zimmerthal	Declared interests should appear on the document rather than on a separate page
DRAFT-CORRECTIONS-/017	Draft corrections and versioning policy	Dr Perpetua Haverkamp-Diallo industry	The disclosure requirements exceed those of comparable bodies
DRAFT-STABILITY-ST/011	Draft standard: freeze–thaw and in-use stability assessment of…	Vittoria Ylönen	Declared interests should appear on the document rather than on a separate page
DRAFT-INDICATION-S/008	Draft indication set and anchor outcomes	Anselm Mountstephen	A superseded version should remain reachable from the version that replaced it
DRAFT-ADOLESCENT-S/011	Draft synthesis: incretin receptor agonists in adolescents	Dr Oisín Rautavaara	Baseline imbalance in a small contributing trial is not remarked on
DRAFT-ADOLESCENT-S/016	Draft synthesis: incretin receptor agonists in adolescents	Quentin Whitmarsh-Obi	A superseded version should remain reachable from the version that replaced it
DRAFT-ANALYTICAL-S/005	Draft analytical review: surveys of unregulated peptide supply	Dr Anselm Thorsby-Nakamura	The chain of custody between purchase and analysis is not described
DRAFT-ANALYTICAL-S/007	Draft analytical review: surveys of unregulated peptide supply	Gervase Crickhowell	Whether the analyst knew the source of each sample is not reported
DRAFT-ANALYTICAL-S/008	Draft analytical review: surveys of unregulated peptide supply	Professor Bartolomeu Nkosi-Lindegaard	Contributing surveys anonymise their sources to different degrees
DRAFT-ANALYTICAL-S/013	Draft analytical review: surveys of unregulated peptide supply	Stellan Cholmondeley-Ade	A superseded version should remain reachable from the version that replaced it
DRAFT-REGISTRY-STR/003	Draft structure of the document registry	Dr Emiliana Ollerenshaw	Declared interests should appear on the document rather than on a separate page
DRAFT-TOOLS-DISCLA/006	Draft terms for the Institute’s calculators	Kolawole Oppenheimer-Ade	The Institute publishes no telephone number and no messaging channel
DRAFT-TOOLS-DISCLA/011	Draft terms for the Institute’s calculators	Amara Vandergraaf	A submission the Institute declines to publish leaves no trace

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