Reference:USA FDA Guidance for Industry Investigator Responsibilities β Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A.: Difference between revisions
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| | |has_document=Document:USA FDA Guidance for Industry Investigator Responsibilities β Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 | ||
| | |module=2 | ||
| | |unit=2.3.2 | ||
| | |scope=G | ||
| | |doc_part=III. A. | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
Β | |tags=TAG-00246-Inv-hte ++ TAG-00248-Inv-die ++ TAG-00329-Saf-lne ++ TAG-00320-Foo-eri ++ TAG-00001-Med-rzn | ||
|tags_display=[[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00248-Inv-die|Investigator oversight]], [[Glossary:TAG-00329-Saf-lne|Safety]], [[Glossary:TAG-00320-Foo-eri|FDA]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]] | |||
Β | |comment=Clarification of certain investigator responsibilities | ||
|content=III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES | |||
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Β | |||
III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES | |||
This section of the guidance clarifies the investigatorβs 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. | This section of the guidance clarifies the investigatorβs 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. | ||
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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. | 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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Revision as of 12:55, 16 July 2026
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry
Investigator Responsibilities β Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry
Investigator Responsibilities β Protecting the Rights, Safety, and Welfare of Study Subjects |
| Version / Revision | Oct-2009 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Guidance for Industry Investigator Responsibilities β Protecting the Rights, Safety, and Welfare of Study Subjects |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 2 β Unit 2.3.2 |
| Scope | G |
| Document part | III. A. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator responsibilities, Investigator oversight, Safety, FDA, Medicinal product |
Content
III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES
This section of the guidance clarifies the investigatorβs 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. [...]
