Consultation record
Submissions accepted
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.
Submissions
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Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-CERTAINTY-FR/001 | Draft revision of the Institute’s certainty assessment framework… | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them |
| DRAFT-CERTAINTY-FR/002 | Draft revision of the Institute’s certainty assessment framework… | Dr Adaeze Underhill-Okafor | The framework should say when a rating must not be issued at all |
| DRAFT-CERTAINTY-FR/007 | Draft revision of the Institute’s certainty assessment framework… | Dr Vasilisa Immelmann | It is not clear which provisions bind the assessment committee |
| DRAFT-CERTAINTY-FR/009 | Draft revision of the Institute’s certainty assessment framework… | Dr Yusuf Whitmarsh-Obi | Nothing states how many assessors rate a body of evidence |
| DRAFT-CERTAINTY-FR/010 | Draft revision of the Institute’s certainty assessment framework… | Dr Vittoria Quintanilha | Nothing prevents a conclusion stronger than its certainty rating |
| DRAFT-CERTAINTY-FR/011 | Draft revision of the Institute’s certainty assessment framework… | Dr Jozef Brandvold-Achterberg | The framework does not say what new evidence would change a rating |
| DRAFT-CERTAINTY-FR/012 | Draft revision of the Institute’s certainty assessment framework… | Dr Ottoline Oppenheimer-Ade | A composite outcome is rated as one outcome |
| DRAFT-CERTAINTY-FR/014 | Draft revision of the Institute’s certainty assessment framework… | Thaddeus Isaksen-Balogun | The treatment of imprecision does not work where the event did not occur |
| DRAFT-SUPPLIER-RUB/001 | Draft supplier evaluation rubric | Dr Vasilisa Immelmann | Two criteria can be satisfied without changing anything a supplier does |
| DRAFT-SUPPLIER-RUB/005 | Draft supplier evaluation rubric | Dr Eamon Immelmann | Whether a purchaser can obtain the record behind a figure is not scored |
| DRAFT-SUPPLIER-RUB/006 | Draft supplier evaluation rubric | Stellan Cholmondeley-Ade | Scores from different rubric versions are presented together |
| DRAFT-SUPPLIER-RUB/008 | Draft supplier evaluation rubric | Dr Zebedee Zaleski-Mbeki | An accreditation claim is scored without being verified |
| DRAFT-SUPPLIER-RUB/010 | Draft supplier evaluation rubric | Dr Frideswide Nordhagen | A high score invites a purchasing decision the rubric cannot support |
| DRAFT-COA-MINIMUM-/002 | Draft certificate-of-analysis minimum data standard | Professor Bartolomeu Nkosi-Lindegaard | A conformance claim is not defined and will be made loosely |
| DRAFT-COA-MINIMUM-/004 | Draft certificate-of-analysis minimum data standard | Dr Yusuf Whitmarsh-Obi | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-COA-MINIMUM-/005 | Draft certificate-of-analysis minimum data standard | Dr Quentin Zimmerthal | The draft prescribes a procedure where it should state performance |
| DRAFT-COA-MINIMUM-/007 | Draft certificate-of-analysis minimum data standard | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them |
| DRAFT-COA-MINIMUM-/008 | Draft certificate-of-analysis minimum data standard | Dr Fitzwilliam Danquah-Öberg | The scope does not say which materials the standard excludes |
| DRAFT-COA-MINIMUM-/009 | Draft certificate-of-analysis minimum data standard | Eamon Sandringham-Adu | A determination does not record the version of the standard it was made under |
| DRAFT-RP-HPLC-PURI/001 | Draft standard: determination of chromatographic purity by… | Dr Liesbeth Nyquist-Obiora | The standard does not state that a determination on one unit says nothing about the batch |
| DRAFT-RP-HPLC-PURI/002 | Draft standard: determination of chromatographic purity by… | Rukayat Zaleski-Mbeki | The matrix interferes with the determination and no control is required |
| DRAFT-SEMAGLUTIDE-/001 | Draft monograph: semaglutide, version 3 | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-SEMAGLUTIDE-/002 | Draft monograph: semaglutide, version 3 | Dr Lorcan Zaleski-Mbeki | Local reactions are omitted from the adverse-event table because the trials reported them separately |
| DRAFT-SEMAGLUTIDE-/003 | Draft monograph: semaglutide, version 3 | Dr Fenella Lavrentiev | Glycaemic trials and weight-management trials are drawn on interchangeably |
| DRAFT-SEMAGLUTIDE-/005 | Draft monograph: semaglutide, version 3 | Dr Delphine Trelawney | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-SEMAGLUTIDE-/006 | Draft monograph: semaglutide, version 3 | Dr Quentin Zimmerthal | Quantitative claims are reproduced without the method that produced them |
| DRAFT-SEMAGLUTIDE-/010 | Draft monograph: semaglutide, version 3 | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-SEMAGLUTIDE-/011 | Draft monograph: semaglutide, version 3 | Dr Yusuf Whitmarsh-Obi | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-SEMAGLUTIDE-/013 | Draft monograph: semaglutide, version 3 | Dr Vittoria Quintanilha | Registered trials that never reported are absent from the monograph |
| DRAFT-SEMAGLUTIDE-/014 | Draft monograph: semaglutide, version 3 | Dr Marisol Dunmore-Ekpo | Open-label extension data are presented alongside randomised data without distinction |
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