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- W2151574480 abstract "In trials on prophylaxis and therapy•The end point adjudication committee must be independent from sponsor and steering committee.•Senior researchers are preferable, not too many to keep the process smooth (2–4 is probably optimal; maybe 3 in case there is voting).•The adjudication committee must be blinded.•Rapid delivery of data, CRFs, hospital records etc. to the committee must be guaranteed (translated in English). The translation must be medically as much as linguistically professional to avoid misunderstandings.•Protocols must be detailed, end point specific but still simple.•Rapid adjudication and classification for feedback to the DSMB. Speeding up this process is for the safety of the patients.•As for the DSMB, the adjudication committee should meet already during the study (and not only when the study is finished) in order to suggest corrections on the input of data and also not to delay the time for unblinding the results.•Recruitment of external expertise whenever judged necessary.•Definition of end points should be discussed and approved by the adjudication committee before the start of the study. Definition must be as exact and detailed as possible (amputation, stroke, MI, bleeding etc), but the committee must also be alert on unexpected findings.•The investigator must motivate why an end point or complication is classified as such. This must be very transparent from the adjudicators.•The adjudication committee must be alert if there are apparent center differences, which could indicate variations in interpretation of inclusion criteria.•Possibility to read and have comments on the manuscript before submission (committee members must be mentioned in all official documents including the final manuscript)." @default.
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- W2151574480 date "2008-12-01" @default.
- W2151574480 modified "2023-09-25" @default.
- W2151574480 title "Adjudication of End Points in Studies on Substances Influencing Haemostasis – an Example from Vascular Surgery" @default.
- W2151574480 cites W2989714602 @default.
- W2151574480 doi "https://doi.org/10.1016/j.ejvs.2008.06.030" @default.
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