Box 73 Membership of the trial management group

♦ Principal investigator

♦ Clinical advisers

♦ One or more expert advisers or independent assessors

♦ Medical statistician

♦ Clinical trials manager

♦ Supporting data management, computing, administrative and secretarial staff good clinical practice, and to complete it within the planned timescale and budget with enough patients and with data that are correct and as complete as possible so that the results of the trial are reliable. These goals can only be achieved by good trial management.

Many of the responsibilities of the trial management group relate to the period up to launch of the trial. Those involving its launch and subsequent conduct are mentioned briefly in this chapter for ease of reference but are described more fully in Chapter 8.

The trial management group is responsible for preparing any funding proposal that maybe needed, overseeing the preparation, printing and distribution of the final protocol and trial documentation, obtaining ethics approval, making any final alterations to the protocol that may be required by the ethics committee (preferably having had the protocol independently and meticulously reviewed for accuracy, comprehensibility and layout), recruiting centres, conducting the trial on a day-to-day basis, undertaking analyses, and ensuring that the results are presented at appropriate scientific meetings and published in peer-reviewed journals.

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