TABLE 5.

Charter, responsibilities and membership of the STAR‐TREC trial monitoring committees

Data Monitoring Committee (DMC)
Responsibilities	The aims of the DMC are (i) to protect and serve STAR‐TREC trial patients (especially in relation to safety) and to assist and advise the Sponsor, via the Chief Investigator and other members of the Trial Management Group (TMG), so as to protect the validity and credibility of the trial; and (ii) to safeguard the interests of participants, assess the safety and efficacy of the interventions, and monitor the overall conduct of the clinical trial A copy of the DMC Charter is available upon request
Relationships	During the recruitment period, interim analyses of the trial's progress including updated figures on recruitment, data quality and completeness, main outcomes and safety will be supplied in strict confidence to the DMC The DMC is independent of the study organizers and advisory to the Sponsor, who remains legally responsible for the conduct of the trial. The DMC should make comments, requests and recommendations to the Chair of the Trials Steering Committee (TSC) for consideration. The Trial Statistician should be kept informed (in strictest confidence) of any discussions to ensure that appropriate records can be maintained on behalf of the Sponsor within the Trial Master File
Membership	Professor Alex Mirnezami, Professor of Surgical Oncology at University Hospital Southampton Foundation Trust, Chair and Surgical Lead Dr Louise Hiller, Associate Professor at Warwick Clinical Trials Unit, University of Warwick, Statistical Lead Dr Amandeep Singh Dhadda, Consultant Clinical Oncologist at Hull University Teaching Hospitals NHS Trust, Radiation Oncology Lead
Trial Steering Committee (TSC)
Responsibilities	The aims of the TSC are (i) to provide independent supervision and oversight of the trial on behalf of the Sponsor and the Trial Funder so as to protect trial patients and the validity and credibility of the trial; (ii) to assist and provide expert advice to the Chief Investigator and other members of the TMG; and (iii) to take the ultimate decision for the continuation of the trial A copy of the TSC Charter is available upon request.
Relationships	During the recruitment period, the TSC will monitor and supervise the progress of the trial towards its overall objectives, review accrual and results of the trial, adherence to the protocol, and consider any new information of relevance to the trial and the research question The TSC has advisory responsibility for the continuation of the trial. The DMC will make recommendations to the TSC who will in turn make recommendations to the Sponsor, via the TMG. The ultimate responsibility for the conduct of the trial, however, rests with the Sponsor
Membership	Professor Maria A. Hawkins, Professor in Radiation Oncology, University College London—Chair and radiation oncology expert Marianne Grønlie Guren, Consultant in Radiation Oncology, Department of Oncology and K.G. Jebsen Colorectal Cancer Research Centre, Oslo University Hospital—Radiation oncology expert Mr Dale Vimalchandran, Consultant Colorectal Surgeon, Countess of Chester Hospital—Colorectal surgery expert Mr Matt Lee, NIHR Clinical Lecturer in General Surgery, University of Sheffield—Colorectal surgery expert Mr Chris Hurt, Senior Research Fellow in Statistics, University of Cardiff—Statistical expert Mrs Ann Russell, Cancer Patient Partnership Group, Addenbrooke's Hospital—Patient representative Mr Simon Bach—STAR‐TREC Chief Investigator, Consultant Colorectal Surgeon, Queen Elizabeth Hospital Birmingham—Sponsor representative (non‐voting member)