WHO Audit DataFrame - Original Coding
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Commitment / activity.
"Key commitments" (as defined by us) are in italics.
Bill and Melinda Gates Foundation
(this has changed since live-cast coding, see "explanatory notes" text at bottom of table!)
UK Medical Research CouncilWellcome TrustInsermResearch Council of NorwayInstitut PasteurPATHCEPIDrugs for Neglected Diseases Initiative (DNDi)Indian Council of Medical ResearchEpicentre - no policiesMédecins Sans Frontières - no policiesLate joiners:UK DFID - no policiesFIND

(after ten mins research on their site it is still unclear to us if they are a funder)
Medicines for Malaria Venture (MMV)
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Background

(not for letters to funders)
In our JAMA audit?yyyynnnnnnnnnnn
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Any mention by the funder of change in policy following WHO statement 2017.n?
they mention it, and they mention policy changing since it, but don't tie two together. possibly not such an interesting thing to code on reflection
?nynnnyyynnnnn
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RegistrationHave a policy on registration.nyynnnnyyynnnyn
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Require that trials are registered.nyynnnnyyy ("All clinical trials must be registered with the Clinical Trial Registry -India (CTRI).")nnnunclear? ("Assist in the registration of trials with a national trial authorization body" "FIND adheres to the registration of all clinical trials")n
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Mention that they’re registered before commencement (“or as soon as possible afterwards” is actual wording).nyynnnnyy ("before data collection")nnnnnn
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Mention registry must be updated as necessary to include final enrollment, and completion date.nnnnnnnynnnnnnn
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Mention registry must be updated if trial terminated, including disclosure of n recruited.nnynnnnnnnnnnnn
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Reporting ResultsHave a policy on reporting resultsnyyynnnyyynnThis is it. "DFID is committed to publication and communication of all evaluations and
research studies."
yn
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Give a timeline / deadlinenyynnnnyynnnnyn
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Report results within 12 months of completion (“we will work towards…as the global norm...”)nyynnnnyynnnnnn
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Mentions registry disclosure (“As timelines for publication in a journal are not fully within the control of the sponsor or investigator, this joint statement focuses on use of registries – such as clinicaltrials.gov and EU-CTR - to meet this results disclosure expectation”).nnynnnnynynnnnn
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Mention journal publication “with an indicative timeframe of 24 months”.nyynnnnnn (mention but without a timeline)nnnny ("Submit all trial data, whether or not relating to commercial products, for publication.." "submitting all results (whether
negative, inconclusive, or positive) for publication in peer reviewed journals within 12 months of study completion, or otherwise making the data available publicly at most within
24 months of study completion...)"
n
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Reporting results - extra elementsMention that protocols should be published by time of results disclosure (“we also encouragement development of requirements…”)nyynnnnnn ("synopsis of clinical trial protocols")nnnnnn
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Mention that protocol should include amendmentsnnnnnnnnnnnnnnn
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Trial ID should be in all results publications, and propagated to PubMed.ny?nnnnnnnnnnnnn
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Plan for disclosure should be included at time of grant submission (note: assessing this may require checking funder’s guidance to applicants).not in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetynot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetn (before trial commencement)n (" the clinical trial protocol should mention the publication policy")not in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yet
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Reasonable funds to ensure compliance is a cost eligible item (assessing this may require checking funder’s guidance to applicants).not in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yet
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Monitoring and incentivising disclosure of past trialsMention that applicants previous track record of publishing results is considered when assessing new grant applications (assessing this may require checking funder’s guidance to applicants).not in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yet
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Mention that PI (“may be…”) asked to provide a list of previous trials as PI, and explanation for any unreported trials (assessing this may require checking funder’s guidance to applicants).not in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yetnot in public docs but not checked guidance for applicants yet
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Monitoring complianceMention of monitoring compliance ("We each agree to monitor registration and endorse the development of systems to monitor results reporting on an ongoing
basis.")
n?n

No mention of rolling audit but one done for 2017
?nnnnnnnnnnnnn
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Mention that outputs of monitoring process are publicly available ("We agree that transparency is important and therefore the outputs from the monitoring process will be publicly available").n?n?nnnnnnnnnnnnn
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Current compliance audit available now.n?y
2017
?nnnnnnnnnnnnn
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IPDMention of being “generally supportive” (note: WHO statement is explicit that IPD sharing is not a focus, registration and results are prioritised as compliance remains poor).generally supportive of data sharing only for things publishedyynynnyyynnyyn
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Open Access
Not a focus of the WHO statement therefore not assessed.
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Explanatory notes
(This will be LONG text, click to read.)

Not for letters to funders.
Note there is a webpage about the Gates Open Research platform, which we initially (in the preliminary live videocast) coded as containing registration requirements for all clinical trials funded by Gates; on closer inspection it is clear that they are setting out the pre-registration requirements for trials to be published in the Gates Open Research "journal". There is therefore no registration policy for Gates funded trials.note they have a lot of docs but the below appears to be the core policy docSome strong elements, we think new (might check against our archives) which seem to reflect specific elements added as a consequence of the WHO statement.As noted previously, many funders have lots on data and OA but not ensuring trials registered adn reported
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Documents, links
(This will be LONG text, click to read.)

Not for letters to funders.
https://mrc.ukri.org/documents/pdf/mrc-policy-on-open-research-data/
https://mrc.ukri.org/documents/pdf/clinical-trials-review-2017/
https://wellcome.ac.uk/funding/managing-grant/wellcome-trust-policy-position-clinical-trialshttps://www.inserm.fr/en/research-inserm/clinical-research/clinical-trials-interventional-studies-on-health-productNothing here https://www.forskningsradet.no/en/Article/Open_access_to_research_data/1240958527698
Nothing here
https://www.forskningsradet.no/en/Open_access/1254008537671
http://cepi.net/sites/default/files/Policy%20Documentation%20-%20v2.0%20-Sept2017.pdf
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