View source for Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A.

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{{:Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Document part
| III. A.
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| EN
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! Original entry by
| Florian Adragna
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! Comment
| Clarification of certain investigator responsibilities
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== Content ==
III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES

This section of the guidance clarifies the investigator’s responsibility to supervise the conduct of the clinical investigation and to protect the rights, safety, and welfare of participants in drug and medical device clinical trials.

A. Supervision of the Conduct of a Clinical Investigation
As stated above, investigators who conduct clinical investigations of drugs, including biological products, under 21 CFR Part 312, commit themselves to personally conduct or supervise the investigation. Investigators who conduct clinical investigations of medical devices, under 21 CFR Part 812, commit themselves to supervise all testing of the device involving human subjects. It is common practice for investigators to delegate certain study-related tasks to employees, colleagues, or other third parties (individuals or entities not under the direct supervision of the investigator). When tasks are delegated by an investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated. The investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of the clinical study.
In assessing the adequacy of supervision by an investigator, FDA focuses on four major areas: (1) whether individuals who were delegated tasks were qualified to perform such tasks, (2) whether study staff received adequate training on how to conduct the delegated tasks and were provided with an adequate understanding of the study, (3) whether there was adequate supervision and involvement in the ongoing conduct of the study, and (4) whether there was adequate supervision or oversight of any third parties involved in the conduct of a study to the extent such supervision or oversight was reasonably possible.
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