Institutional Review Board
Guidance on Serious Adverse Event Reporting / II.2.F
II.2.G
DEFINITIONS
Serious Adverse Event
Any adverse event associated with the use of the drug/device or research intervention that result in any of the following outcomes: death, a life-threatening adverse event, 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 above.
Unanticipated Adverse Event
Any adverse event associated with the use of the drug/device or research intervention, the specificity or severity of which 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 provided to subjects (in the Informed Consent Document) and the IRB. Please note that the natural progression of a subject’s underlying disease, disorder or condition is “expected.”
Unanticipated Problem Any adverse event that meets all of the following criteria is considered an unanticipated problem.
· The event must be unanticipated (according to the above definition)
· The event must be associated with the research (at least possibly related)
· The event must suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized
REPORTING REQUIREMENTS
Adverse events that meet the following definitions must be reported to the IRB as soon as possible, and no later than 10 days after the investigator becomes aware of the event using the Serious and/or Unanticipated Adverse Event Form.
Subjects Enrolled at MMC or MMC-owned/affiliated Sites
Submit this form if the adverse event meets EITHER definition – serious or unanticipated. Note that both definitions require an association with the use of a drug/device or research intervention. If a serious or unanticipated adverse event is “Definitely Not Related” to the drug/device or research intervention, it does not need to be reported to the IRB. The IRB will be made aware of unrelated deaths on the annual progress report.
Unanticipated Problem Adverse Event at MMC or MMC-owned/affiliated Sites
Submit this form if the adverse event meets the definition of an unanticipated problem adverse event as listed above. Note that there are additional reporting requirements indicated on the form. The event may require additional reporting by the IRB to OHRP at DHHS and the institutional official.
Subjects Enrolled at Other Sites by Non-MMC Investigators
Submit this form only if the adverse event meets the definition of SERIOUS AND UNANTICIPATED AND IS POSSIBLY, PROBABLY, OR DEFINITELY RELATED to the study drug, device or research intervention. The IRB does not require submission of this form for subjects enrolled at other sites unless all three conditions are met. If the adverse event being reported does not meet all of these conditions, it will be placed in the project file without IRB review or comment.
Follow-Up Reports
If this a SAE report is submitted as a follow-up of a previously reported adverse event, it will be placed in the project file without IRB review or comment unless the follow-up meets the above criteria.
Please note—if the person signing the SAE event form is someone other than the principal investigator, please assure that the principal investigator is aware of this event.
FDA Guidance for Serious Adverse Event Reporting
OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
GENE THERAPY STUDIES: Investigators who have received approval from FDA to initiate a human gene transfer protocol must submit a written report of serious adverse events that are unanticipated and associated with the use of the gene transfer product to the NIH Office of Biotechnology Activities (NIH/OBA), the MMC Institutional Biosafety Committee, the IRB, and the FDA or study sponsor within specified timeframes as found in Appendix M-1-C-4 in the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). Gene therapy investigators must submit annual reports to OBA as set forth in Appendix M-1-C-3 of the NIH Guidelines.
Page 2 of 2 / SOP RR 404-B Effective Date 10/01/2010 Supersedes 12/01/2008