Abstract

Background Careful site selection methods and tools such as questionnaires have evolved to become “best” practice in the commercial and non-commercial clinical trials setting. However, there is little evidence in the literature of the value of such methodology on trial delivery and there is no generally acceptable model or tool available for use in site selection. The Nottingham Clinical Trials Unit introduced a site selection questionnaire in 2010, consisting of both generic research related questions and study specific protocol driven requirements for identification of potential sites in four multi-centre trials. Initially questionnaires were sent to Principal Investigators at sites who had expressed an interest in participating in the trials.

Highlights

  • Careful site selection methods and tools such as questionnaires have evolved to become “best” practice in the commercial and non-commercial clinical trials setting

  • How site selection questionnaires might improve trial conduct for trials involving a large number of centres

  • The site selection questionnaire was assessed based on the number of questionnaires sent out, return rates, timeliness of returns, completeness of data, and performance against predicted recruitment targets were compared

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Summary

Introduction

Careful site selection methods and tools such as questionnaires have evolved to become “best” practice in the commercial and non-commercial clinical trials setting. Evaluation of a site selection questionnaire for the recruitment of trial sites into multi-centre trials: experiences from the nottingham clinical trials unit From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK.

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