Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009

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Status	Superseded / Invalid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

Reference	Scope	Document part	Language	Preview
Reference: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 Unanticipated Problem that Needs to Be Reported ...
Reference: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 adverse events5 must be communicated among ...
Reference: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 adverse events5 must be communicated among ...