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

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Status	Superseded / Invalid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

Reference Details
Module	Module 5 — Unit 5.3.6
Scope	G
Document part	Introduction ; III. B. ; Evaluation
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Adverse event, Unanticipated device effect, Investigational drug (IMP), Ethics committee, FDA
Comment	AE reporting under IND and IDE for drugs and biologics

Content

[...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adverse events5 must be communicated among investigators, sponsors, and IRBs as follows: [...] - Sponsors are specifically required to notify all participating investigators (and FDA) in a written IND safety report of “any adverse experience associated with the use of the drug that is both serious and unexpected” and “any finding from tests in laboratory animals that suggests a significant risk for human subjects” (§ 312.32(c)(1)(i)(A),(B)). And, more generally, sponsors are required to “keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use” (§ 312.55(b)). [...] III. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DRUG AND BIOLOGICAL PRODUCTS CONDUCTED UNDER IND REGULATIONS B. How to Report Unanticipated Problems to IRBs [...] Accordingly, to satisfy the investigator’s obligation to notify the IRB of unanticipated problems, an investigator participating in a multicenter study may rely on the sponsor’s assessment and provide to the IRB a report of the unanticipated problem prepared by the sponsor. In addition, if the investigator knows that the sponsor has reported the unanticipated problem directly to the IRB, because the investigator, sponsor, and IRB made an explicit agreement for the sponsor to report directly to the IRB,8 and because the investigator was copied on the report from the sponsor to the IRB, FDA intends to exercise its enforcement discretion and would not expect an investigator to provide the IRB with a duplicate copy of the report received from the sponsor. [...] IV. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DEVICES UNDER THE IDE REGULATIONS UADEs must be reported by the clinical investigator to the sponsor and the reviewing IRB, as described below: [...] Sponsors must immediately conduct an evaluation of a UADE and must report the results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days after the sponsor first receives notice of the effect (§§ 812.46(b), 812.150(b)(1)).

The IDE regulations, therefore, require sponsors to submit reports to IRBs in a manner consistent with the recommendations made above for the reporting of unanticipated problems under the IND regulations. [...]