Membership and functions of the trial steering committee

The membership and functions of the trial steering committee are summarized in Box 8.7. Their role is to provide an element ofindependent supervision over the conduct of a trial and, in this sense, fulfill an executive role for the sponsor. They are thus responsible for ensuring that the trial management group is fulfilling all its roles satisfactorily, and that any problems are dealt with rapidly and appropriately.

Membership

The membership of the committee must enable it to have available all information it is likely to need on the day-to-day conduct of the trial, and yet to provide truly independent supervision. It should therefore include, in addition to the members of the trial management group, an independent chairman, at least one other independent member, and a representative of the sponsoring organization. Not all members of the committee will necessarily need to attend every meeting.

As for the data monitoring and ethics committee, the independent members must be truly independent of all those involved in the trial.

Functions

Supervising the progress of the trial It is helpful for the committee to meet soon after each meeting of the data monitoring and ethics committee, so that they can make decisions

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