Principal investigator

It is essential to identify a principal investigator. This is the person ultimately responsible for initiating the trial, organizing and obtaining any funding that maybe needed, organizing any relevant industrial support, conducting the trial in collaboration with the other members of the trial management group, and taking the lead in preparing reports for publication. The principal investigator must ensure that all collaborating personnel fully understand the trial, their responsibilities and roles in its conduct, and the procedures involved. Principal investigators are typically clinicians and, as such, provide expert clinical advice to collaborating centres; they will usually have limited time to devote to the conduct of the trial but should nevertheless accept final responsibility for the functions shown in Box 7.4, even if many of these are shared or delegated.

Thus, principal investigators need to take ultimate personal responsibility for the success of the trial; they should randomize as many of their own patients as they can, and encourage others to do the same. They are responsible for ensuring that the trial is run ethically, efficiently and to the highest standards, and should ensure that appropriate independent expert advice, assessment, and monitoring are available. The principal

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