Adverse Events Reporting

Adverse events (AEs) may occur during a clinical trial. Current federal regulations require reporting of AEs in all categories of clinical trials to the institutional IRB, in addition to other relevant parties. Other possible destinations for AE reports include the sponsor (if an IND is involved), the FDA (for AEs from commercially available agents), and, if gene transfer is involved, the NIH Office of Biotechnology Activities (OBA).

Definition of Adverse Events

University of California, Irvine
An adverse event (AE) is an unanticipated negative effect. AE reports must be filed with the Institutional Review Board (IRB) when any of the following happen to a subject on a study:

Death

Hospitalization (including extension of a planned hospital stay)

Unanticipated negative effect requiring treatment

Unusual or high frequency of expected effects (as described in the "Risks" section of the approved informed consent document)

Any other suspicious negative effect when, in the opinion of the Lead Researcher, there may be a relationship to the study

Birth defect/congenital anomaly (adverse pregnancy outcome following exposure to study procedures prior to conception or during pregnancy)

Federal Guidelines – Common Rule
The notification requirements described in the Common Rule define adverse events as “unanticipated problems” involving risks to study participants or others.

Federal Guidelines – National Institutes of Health
Generally, the funding Institutes and Centers establish operational definitions of adverse events that apply to the particular trial. The National Cancer Institute (NCI), for example, defines adverse drug reactions in its clinical trials involving antineoplastic agents, as: (1) previously unknown toxicities; and (2) life-threatening or fatal toxicities regardless of whether or not previously unknown. Toxicity criteria are generally included in the protocols.

Federal Guidelines – Food and Drug Administration
The FDA, in Federal regulations 21 CFR Part 312, defines adverse events as any untoward medical occurrence that may present itself during treatment or administration with a pharmaceutical product, and which may or may not have a causal relationship with the treatment. In the guideline entitled “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting”, the Agency further clarifies and defines serious adverse events stemming from a drug study as any untoward medical occurrence that at any dose results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; creates persistent or significant disability/incapacity, or a congenital anomaly/birth defects (http://www.fda.gov/cder/guidance/iche3.pdf).

Adverse Event Reporting

Relevant Links

http://www.rgs.uci.edu/researchprotections/irb/adverseexperiences.htm
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

Site best viewed in 800x600 resolution or above.
Questions or Comments? Contact Us