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									Adverse Events Reporting
Definitions

Serious Adverse event means any adverse experience that results in any of the following outcomes:
death, a life-threatening experience, inpatient hospitalization or prolongation of existing
hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Important medical events that may not result in death, be life-threatening or require hospitalization
may be considered a serious adverse event when, based upon appropriate medical judgment, they may
jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the
outcomes listed in this definition.

Unexpected Adverse event is any adverse experience associated with the study article for which the
specificity or severity is not consistent with the current investigator brochure, or, if an investigator
brochure is not required or available, the specificity or severity of which is not consistent with the risk
information described in the general investigational plan or elsewhere in the current application, as
amended. "Unexpected" refers to an adverse drug experience that has not been previously observed.

Associated with the Study Article means that there is a reasonable possibility that the experience
may have been caused by the study article.

SPONSOR-INVESTIGATORS HAVE ADDITIONAL REPORTING REQUIREMENTS TO
SPONSORS, THE FDA, OHRP, NIH/OBA, AND OTHER COMMITTEES, AS APPLICABLE,
AND SHOULD CONSULT THE APPLICABLE FEDERAL REGULATIONS AND AGENCY
GUIDANCE FOR THESE REQUIREMENTS. INVESTIGATORS SHOULD ALSO BE AWARE
OF LOCAL FACILITY REQUIREMENTS FOR REPORTING ADVERSE EVENTS

ADVERSE EVENT REPORTING REQUIREMENTS for SPONSOR-INVESTIGATOR

Reports to:                                              When to report              Regulatory
                                                                                     Citation
To the FDA:      Any unexpected fatal or life            As soon as possible but no 21 CFR 312.32
                 threatening experience associated       later than 7 calendar days
                 with the use of the drug.               after the sponsor’s initial
                                                         receipt of the information
                 Any adverse experience associated Within 15 calendar days 21 CFR 312.32
                 with the use of the drug that is both after the sponsor’s initial
                 serious and unexpected                receipt of the information


                 Unanticipated adverse device effects No later than 10 working 21 CFR 812.150.
                                                      days of receipt of the
                                                      information
                 Applicant having approved           within 15 calendar              21 CFR 314.80(c)
                 application under 314.50 (NDA) must days of receipt of new
                 report any adverse drug experience information
                 that is both serious and unexpected
                 whether domestic or foreign
                 (postmarketing reporting of adverse
                 event experiences)
                Any person having a product license   Within 15 calendar days 21 CFR 600.80(c)
                under 601.20 (biological product)     after the initial receipt of
                must report any adverse experience    the information by the
                that is both serious and unexpected   licensed manufacturer
                whether domestic or foreign.


To other        Any adverse experience associated Within 15 calendar days 21 CFR 312.32
investigators   with the use of the drug that is both after the sponsor’s initial
                serious and unexpected                receipt of the information



                Any unexpected fatal or life          As soon as possible but no 21 CFR 312.32
                threatening experience associated     later than 7 calendar days
                with the use of the drug.             after the sponsor’s initial
                                                      receipt of the information


To the IRB:     Unanticipated problems involving Promptly.                       45 CFR
                risk to subjects or others.                                      46.103(b)(5);
                                                                                 21 CFR 56.108 (b)
                                                                                 (1)
                All adverse reactions that are both   within 15 calendar days of ICH Guideline
                serious and unexpected                the Investigator learning for Good Clinical
                                                      of the event.              Practice §3.3.8.


                Unanticipated adverse device effects No later than 10 working 21 CFR 812.150.
                                                     days after the investigator
                                                     first learns of the effects



Other adverse events, e.g. other adverse drug reactions that are reported in the Investigator's Annual
Report submitted to Sponsors, should be included in the investigator's Request for reapproval or Study
Closure submitted for the IRB's review,

								
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