Box 74 Functions of the principal investigator

♦ Respond promptly to clinical queries raised by collaborating centres. Such queries commonly include the boundaries of eligibility criteria, finer details of treatment (including permissible minor variations from protocol), toxicity, supportive care, and the best ways of explaining the trial to patients

♦ Look for, and accept, opportunities for promoting the trial and encouraging colleagues to collaborate

♦ Establish contact with groups undertaking similar trials and exchange information with them on progress

♦ Present information on the progress of the trial at collaborators' meetings and respond to any queries or problems raised about collaborating in the trial. Any areas of legitimate major concern should be raised with the data monitoring and ethics committee or trial supervisors (see Section 8.10)

♦ Communicate with patient advocacy groups on the reasons for conducting the trial and on its progress

♦ Collaborate in preparing regular reports for the trial sponsors and supervisors

♦ In collaboration with other members of the trial management group, present results at conferences and draft reports for publication investigator must therefore keep the trial monitors and supervisors (see Section 8.10) informed about the progress of the trial and about any problems that may arise during its conduct.

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