Report for: Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial

Title	Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial
Published in	Trials, May 2011
DOI	10.1186/1745-6215-12-112
Pubmed ID	21548932
Authors	Elizabeth P Tolmie, Eleanor M Dinnett, Elizabeth S Ronald, Allan Gaw, the AURORA Clinical Endpoints Committee
Abstract	The UK Clinical Trial Regulations and Good Clinical Practice guidelines specify that the study sponsor must ensure clinical trial data are accurately reported, recorded and verified to ensure patient safety and scientific integrity. The methods that are utilised to assess data quality and the results of any reviews undertaken are rarely reported in the literature. We have recently undertaken a quality review of trial data submitted to a Clinical Endpoint Committee for adjudication. The purpose of the review was to identify areas that could be improved for future clinical trials. The results are reported in this paper.

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Other	4	15%
Unknown	4	15%

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Psychology	2	8%
Business, Management and Accounting	1	4%
Other	4	15%
Unknown	4	15%

Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial