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The importance of an independent oversight committee to preserve treatment fidelity, ensure protocol compliance, and adjudicate safety endpoints in the ATACH II trial

In response to growing trends and accepted U.S. Food and Drug Administration (FDA) guidance, the ATACH II trial leadership developed the independent oversight committee (IOC) as a mechanism to adjudicate the trial safety endpoints and to evaluate treatment fidelity and protocol compliance. To accomp...

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Autori principali: McBee, NA, Hanley, DF, Kase, CS, Lane, K, Carhuapoma, JR
Natura: Artigo
Lingua:Inglês
Pubblicazione: Zeenat Qureshi Stroke Research Center 2012
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3517026/
https://ncbi.nlm.nih.gov/pubmed/23230459
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