Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry
Investigator Responsibilities — 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 — 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 — Protecting the Rights, Safety, and Welfare of Study Subjects |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. | G | III. A. | EN | III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES This section of the guidance clarifies the investigator’s responsibility to supervise the… |
| USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B. | G | III. B. | EN | III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES
[...] B. Protecting the Rights, Safety, and Welfare of Study Subjects Investigators are re… |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. | G | III. A. | EN | 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 ... |
| Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B. | G | III. B. | EN | 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 ... |
