Reference:USA FDA Guidance for Industry Investigator Responsibilities â Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B.: Difference between revisions
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry
Investigator Responsibilities â 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 â 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 â 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 â Unit 2.4.0 |
| Scope | G |
| Document part | III. B. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator oversight, Safety, Trial participant, FDA |
| Comment | Protecting rights, safety and welfare of research participants |
Content
III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES [...] B. Protecting the Rights, Safety, and Welfare of Study Subjects Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial (21 CFR 312.60 and 812.100). This responsibility should include: ⢠Providing reasonable medical care for study subjects for medical problems arising during participation in the trial that are, or could be, related to the study intervention ⢠Providing reasonable access to needed medical care, either by the investigator or by another identified, qualified individual (e.g., when the investigator is unavailable, when specialized care is needed) ⢠Adhering to the protocol so that study subjects are not exposed to unreasonable risks The investigator should inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and the subject agrees to the primary physician being informed. [...]
