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

By E. Tolmie, E.M. Dinnett, E.S. Ronald and A. Gaw


<p>Background: 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.</p>\ud \ud <p>Methods: Throughout the course of the study, all data queries were logged. Following study close out, queries were coded and categorised. A descriptive and comparative analysis was conducted to determine the frequency of occurrence for each category by country of origin.</p>\ud \ud <p>Results: From 1595 endpoint packages reviewed, 782 queries were generated. No source data queries were generated for countries with ≤ 25 recruited subjects, but both low recruiting and high recruiting countries had a high number of queries relating to subject identifiers.</p>\ud \ud <p>Conclusions: The implementation of some simple measures could help improve data quality and lead to significant savings.</p

Topics: R1
Publisher: BioMed Central
Year: 2011
OAI identifier:
Provided by: Enlighten

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