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Open Access Research

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

Elizabeth P Tolmie1*, Eleanor M Dinnett2, Elizabeth S Ronald3, Allan Gaw1 and the AURORA Clinical Endpoints Committee

Author Affiliations

1 Glasgow Clinical Research Facility, Tennent Building, Western Infirmary, Glasgow, UK

2 NHS Greater Glasgow & Clyde Pharmacovigilance Office, Robertson Centre for Biostatistics, Boyd Orr Building, Glasgow, UK

3 Scottish Stroke Research Network, Walton Building, Glasgow Royal Infirmary, Glasgow, UK

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Trials 2011, 12:112  doi:10.1186/1745-6215-12-112

Published: 6 May 2011

Abstract

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.

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.

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.

Conclusions

The implementation of some simple measures could help improve data quality and lead to significant savings.