Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs β Improving Human Subject Protection Jan-2009
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Clinical
Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs β 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 β 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| Status | Superseded / Invalid |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 β Improving Human Subject Protection |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs β 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 Unanticipated Problem that Needs to Be Reported ... |
| Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs β 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 adverse events5 must be communicated among ... |
| Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs β 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 adverse events5 must be communicated among ... |
