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BACKGROUND The Medical Research Council Guidelines for Good Clinical Practice outlines a three-committee trial oversight structure--the day-to-day Trial Management Group, the Data Monitoring Committee and the Trial Steering Committee. In this model, the Trial Steering Committee is the executive committee that oversees the trial and considers the(More)
Preface Publicly funded Clinical Trials Units (CTUs) provide infrastructure and multidisciplinary teams of researchers that design, conduct, analyse and report clinical trials. Sharing Individual Participant Data (IPD) from clinical trials offers numerous well recognised advantages that can advance clinical research and benefit patients. The clinical trial(More)
BACKGROUND The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring Committee (DMC) and an independent executive committee, to whom the DMC makes recommendations. The detailed roles and function of this(More)
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