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Delegation of Authority and Supervision of the Conduct of a Clinical Trial

The investigator who conducts clinical investigations with both drugs and devices commits to personally conduct or supervise all aspects of the investigation.

The investigator is legally responsible for all aspects of the investigation and cannot delegate this responsibility to another individual.

It is common practice for investigators to delegate certain study-related tasks to employee, colleagues, or other third parties (individuals or organizations not under the direct supervision of the investigator). When tasks are delegated by the investigator, the investigator is responsible for providing adequate supervision or those to whom tasks are delegated and the investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of the study.

The investigator must have sufficient time to properly conduct and supervise the clinical trial. The intensity of the supervision must be appropriate to the staff, the nature of the trial, and the subject population.

In assessing the adequacy of supervision by an investigator, the FDA focuses on four major issues:

  1. Whether delegated individuals are qualified to perform such tasks
  2. Whether study staff receive adequate training on how to conduct the delegated tasks and have adequate understanding of the study
  3. Whether there was adequate supervision and involvement in the conduct of the study
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