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Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs β€” Improving Human Subject Protection Jan-2009: Difference between revisions

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Adverse Event Reporting to IRBs β€” Improving Human Subject Protection
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|reference=USAΒ  FDA Guidance for Clinical
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Line 47: Line 23:
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== References ==
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! 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 ...
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Latest revision as of 14:15, 16 July 2026


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Status Superseded / Invalid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

 ScopeDocument partLanguagePreview
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs β€” Improving Human Subject Protection Jan-2009 III A. ; IV.GIII 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 β€” Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; EvaluationGIntroduction ; III. B. ; EvaluationEN[...] 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 β€” Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV.GIntroduction ; III. B. ; IV.EN[...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adv…
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