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Adverse Events

Federal regulations do not specifically address adverse event reporting, however they require prompt reporting to the IRB of any unanticipated problems involving risks to subjects or others.

Some of the adverse events experienced by subjects enrolled in research studies will meet the criteria for unanticipated problems involving risks to subjects or others and so must be reported promptly to the National Jewish Medical and Research Center IRB (NJMRC IRB). However, the vast majority of adverse events, both serious and non-serious, occurring in the context of research are expected in light of the known toxicities and side effects of the research procedures or are expected due to the natural history of subjects’ underlying diseases and conditions. Thus, most individual adverse events do not represent unanticipated problems subject to the reporting requirements outlined in the federal regulations at 45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1).

The NJMRC IRB considers the following types of adverse events to meet the criteria of “unanticipated problems involving risks to subjects or others” that must be promptly reported:

  • Signs of high-risk behavior exhibited in subjects that can potentially cause harm to oneself or others (report directly to IRB Chair within 1 business day, written report to the IRB office within 3 business days)
  • Deaths in interventional studies and related deaths in non-interventional studies that occur in subjects enrolled locally for which NJMRC IRB is the IRB of record (within 5 business days)
  • Serious adverse events (other than death and signs of high-risk behavior) that occur in subjects enrolled locally for which the NJMRC IRB is the IRB of record (within 10 business days)
  • Unanticipated AND related adverse event that occurs in a subject enrolled locally for which the NJMRC IRB is the IRB of record (within 10 business days)
  • External adverse event reports received from the Sponsor that requires a change in the protocol and/or consent form, alter the approved risk/benefit ratio of the study, or results in a study hold or suspension (within 5 business days)
  • External adverse events received from the Sponsor occurring at other sites that are part of your current multi-center protocol that do not require changes in the protocol and/or consent form, alter the approved risk/benefit ratio of the study, or result in a study hold or suspension (within 10 business days)

Download: Forms, Policies and Regulations

Adverse Event Reporting Memo

Data Safety Monitoring Report

Federal regulations require that the study design include some mechanism to monitor adverse events and other ongoing study data: "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects" (45 CFR 46.111(a)(6)).  Often times, this requirement is met through the use of Data Safety Monitoring Bodies.

Data Safety Monitoring Report Instructions

Data Safety Monitoring Report -Template Form

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