Table 6

Roles and responsibilities in the prime trial

Role	Details and responsibilities
Trial sponsor	University College London (UCL) Sponsor’s Edge reference: 135 819 Email: Rand.D@uclh.nhs.uk The trial sponsor did not provide any funding for the study. UCL has the role of research governance sponsor of PRIME. UCL adopted the study as sponsor after the UCL CCTU carried out a trial adoption process which involved the UCL CCTU reviewing the protocol to ensure it conformed to high standards of trial conduct and met the governance requirements of UCL. The UCL CCTU is responsible for oversight of the trial. The sponsor plays no role in data collection, management, analysis and interpretation of data, writing of the report or the decision to submit the report for publication.
PRIME operations group	The PRIME operations group consists of the CI, the Clinical Operations Group, National Cancer Imaging Translational Accelerator, the UCL Surgical and Interventional Trials Unit and the electronic case report form database managers. This group is responsible for Study planning. Preparation of protocol and revisions. Assistance with international review board/independent ethics committee applications. Preparation of investigators brochure and CRFs. Organisation of steering committee meetings. Provide annual progress reports to the ethics committee. Reporting serious adverse events to the sponsor and ethics committee when necessary. Responsible for trial master file. Budget administration and contractual issues with individual centres. Advice for PIs. Site initiation visits. Data verification and management. Central monitoring and resolving data queries with clinicians and nurses at the trial sites. Maintenance of the trial information technology system. Publication of study reports.
PI	At each participating site, the PI is responsible for the conduct of the clinical trial to ensure the safety of participants and the reliability and robustness of the data generated. They will be responsible for identification, recruitment, data collection and completion of CRFs, along with follow-up of trial patients and adherence to trial protocol. The PIs as leader of the research team may delegate their duties to members of their team.
Global TSC	The NCITA global prostate TSC is responsible for the governance of the PRIME study, and they have delegated safety to a DMSC. Roles and responsibilities To act as the oversight body for up to five prostate cancer studies on behalf of the sponsor and funders. In addition, the independent members will form a subcommittee to review safety. The role of the TSC is to provide oversight for the studies and provide advice through its chair to the CIs, work in tandem with the DMSC, sponsor, funders and host institution on all aspects of the studies. The rights, safety and well-being of the study participants are the most important consideration and should prevail over the interests of science and society.

CCTU, Comprehensive Clinical Trials Unit; CI, chief investigator; DMSC, data monitoring subcommittee; PI, principal investigator; TSC, trial steering committee; UCL, University College London.