Skip to main content


We’d like to understand how you use our websites in order to improve them. Register your interest.

Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience

The DAMOCLES project established a Data Monitoring Committee Charter which has been widely used for randomised controlled trials since 2005. As established within DAMOCLES, the DMC is typical advisory, making recommendations to another executive body; considered the Trial Steering Committee. No evidence-based Charter exists for TSCs to establish their role and functionality in RCTs.

The MRC Guidelines for Good Clinical Practice (1998) defines a three committee oversight structure: the day-to-day Trial Management Group, the DMC and the executive TSC. The document provides brief Terms of Reference for TSCs and represents the first attempt at guidance on TSC remit and structure. It is not known whether or how extensively this document has been used to inform TSC-like current roles and practice. There is acknowledged variation in practice in the UK and, moreover, internationally.

The aim of this project was to re-visit the MRC Terms of Reference and provide dedicated guidance on TSC remit and structure by producing a comprehensive Terms of Reference and Charter that will promote a systematic and transparent approach to the oversight of RCTs.

To inform this development, a survey to establish current practice and requirements within UK registered Clinical Trials Units has been undertaken. A cohort of published RCTs within medical journals and HTA monographs has been obtained to determine how TSC activities are currently reported and the literature reviewed to identify case studies of TSC activity in RCT conduct.

Results of this work will be presented with how these findings impact development of more complete guidelines.

Author information



Corresponding author

Correspondence to EJ Conroy.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

Conroy, E., Lewis, S., Lane, A. et al. Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience. Trials 14, P128 (2013).

Download citation


  • Randomise Control Trial
  • Monitoring Committee
  • Current Role
  • Trial Management
  • Data Monitoring Committee


By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.