The research team

The sponsor will need to be convinced that trial management is likely to be efficient. It is therefore necessary to describe how the trial will be coordinated and by whom.

♦ List all the team members and proposed investigators who will be conducting the trial, that is, the trial management group.

♦ Describe the responsibilities of each team member, demonstrating that collectively they cover the required range of disciplines and possess the necessary skills and qualifications.

♦ Indicate whether the team already has experience in completing large multi-centre trials successfully. In the case of a small group wishing to conduct a local trial, indicate what experience the group has and what advice is readily available to it.

♦ Provide a list (possibly as an appendix) of all the centres and consultants who have expressed an interest in collaborating, indicating the numbers of patients that these centres expect to be able to randomize each year.

If required by the sponsor, list the members of the supervisory committee, and suggest possible members of an independent data monitoring and ethics committee (if different from the supervisory committee), indicating whether or not they have been approached and agree to fulfill their required functions.

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