Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009
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| Document information | |
|---|---|
| Reference | USA FDA Guidance for Clinical
Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Clinical
Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection |
| Version / Revision | Jan-2009 |
| Status | Superseded / Invalid |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Guidance for Clinical Investigators, Sponsors, and IRBs
Adverse Event Reporting to IRBs — Improving Human Subject Protection |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. | G | III A. ; IV. | EN | [...]
III. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DRUG AND BIOLOGICAL PRODUCTS CONDUCTED UNDER IND REGULATIONS A. How to Determine If an AE is an… |
| USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation | G | Introduction ; III. B. ; Evaluation | EN | [...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adv… |
| USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV. | G | Introduction ; III. B. ; IV. | EN | [...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adv… |
