Consultation record
Submissions accepted — page 5
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
681 documents · page 5 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-CORRECTIONS-/012 | Draft corrections and versioning policy | Dr Rukayat Zaleski-Mbeki | The same concept is given three different names in one document |
| DRAFT-CORRECTIONS-/015 | Draft corrections and versioning policy | Dr Jolyon Grünbaum-Sowande | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-CORRECTIONS-/007 | Draft corrections and versioning policy | Dr Eamon Sandringham-Adu | The policy does not say what happens to a document the Institute is asked to remove |
| DRAFT-STABILITY-ST/014 | Draft standard: freeze–thaw and in-use stability assessment of… | Dr Wolfram Kaltenbach-Mensah | The scope does not say which materials the standard excludes |
| DRAFT-STABILITY-ST/008 | Draft standard: freeze–thaw and in-use stability assessment of… | Dr Nadezhda Lavrentiev industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-STABILITY-ST/011 | Draft standard: freeze–thaw and in-use stability assessment of… | Yusuf Whitmarsh-Obi | The limitations section states what the method cannot do but not what a reader will wrongly conclude |
| DRAFT-STABILITY-ST/015 | Draft standard: freeze–thaw and in-use stability assessment of… | Dr Mordecai Bellingham-Ojo | The standard assumes a reference standard of known assigned content |
| DRAFT-STABILITY-ST/004 | Draft standard: freeze–thaw and in-use stability assessment of… | Dr Rukayat Zaleski-Mbeki | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-STABILITY-ST/012 | Draft standard: freeze–thaw and in-use stability assessment of… | Dr Amara Quaresma | Terms are used in senses that differ from established pharmacopoeial usage |
| DRAFT-STABILITY-ST/001 | Draft standard: freeze–thaw and in-use stability assessment of… | Dr Georgiana Mountstephen | Rounding conventions are not stated and change the reported result |
| DRAFT-STABILITY-ST/003 | Draft standard: freeze–thaw and in-use stability assessment of… | Rosalind Petrossian | The matrix interferes with the determination and no control is required |
| DRAFT-STABILITY-ST/009 | Draft standard: freeze–thaw and in-use stability assessment of… | Dr Prosper Vercingetorix | The search date is not on the face of the document |
| DRAFT-INDICATION-S/001 | Draft indication set and anchor outcomes | Dr Oswin Yorkstone | Quantitative claims are reproduced without the method that produced them |
| DRAFT-INDICATION-S/014 | Draft indication set and anchor outcomes | Dr Vittoria Ylönen | The default ordering of a comparison table carries an implication |
| DRAFT-INDICATION-S/011 | Draft indication set and anchor outcomes | Dr Katarzyna Oppenheimer-Ade | A printed copy loses the information that makes it checkable |
| DRAFT-INDICATION-S/012 | Draft indication set and anchor outcomes | Dr Ivo Quintanilha | A field the Institute could not verify should be shown rather than omitted |
| DRAFT-INDICATION-S/009 | Draft indication set and anchor outcomes | Dr Vittoria Ylönen industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-INDICATION-S/013 | Draft indication set and anchor outcomes | Dr Mordecai Glendinning-Uche | A withdrawn document should not simply disappear |
| DRAFT-INDICATION-S/006 | Draft indication set and anchor outcomes | Dr Henrike Jastrzębska | The same concept is given three different names in one document |
| DRAFT-MASH-SYNTHES/002 | Draft synthesis: incretin receptor agonists for metabolic… | Dr Sigrún Lavrentiev | Quantitative claims are reproduced without the method that produced them |
| DRAFT-MASH-SYNTHES/008 | Draft synthesis: incretin receptor agonists for metabolic… | Dr Amara Quaresma | Studies using different outcome definitions are pooled into one estimate |
| DRAFT-MASH-SYNTHES/010 | Draft synthesis: incretin receptor agonists for metabolic… | Dr Wolfram Kaltenbach-Mensah | The search date is not on the face of the document |
| DRAFT-MASH-SYNTHES/009 | Draft synthesis: incretin receptor agonists for metabolic… | Dr Amara Vandergraaf | A single-trial result is presented in the visual form of a pooled estimate |
| DRAFT-MASH-SYNTHES/011 | Draft synthesis: incretin receptor agonists for metabolic… | Dr Fenella Lavrentiev | Intention-to-treat and efficacy-estimand results are combined without distinction |
| DRAFT-MASH-SYNTHES/012 | Draft synthesis: incretin receptor agonists for metabolic… | Ludmila Brackenridge industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-ADOLESCENT-S/013 | Draft synthesis: incretin receptor agonists in adolescents | Kolawole Oppenheimer-Ade | Quantitative claims are reproduced without the method that produced them |
| DRAFT-ADOLESCENT-S/016 | Draft synthesis: incretin receptor agonists in adolescents | Dr Wojciech Kaltenbach-Mensah | The same concept is given three different names in one document |
| DRAFT-ADOLESCENT-S/003 | Draft synthesis: incretin receptor agonists in adolescents | Hortensia Hollingworth | Intention-to-treat and efficacy-estimand results are combined without distinction |
| DRAFT-ADOLESCENT-S/009 | Draft synthesis: incretin receptor agonists in adolescents | Dr Fitzwilliam Danquah-Öberg | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-ADOLESCENT-S/010 | Draft synthesis: incretin receptor agonists in adolescents | Adaeze Underhill-Okafor | A single-trial result is presented in the visual form of a pooled estimate |
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