Adverse Event Reporting

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Reporting Requirements:

In accordance with the Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA) and the UNLV Human Subject Policy, the UNLV IRB is required to conduct continuing review of research. Included in the continuing review is the monitoring of adverse reactions and unexpected events (21 CFR 56.108 and 45 CFR 46.103). Additionally, an adverse event (AE) can and should be reported at any time throughout the study protocol.

An adverse event is any untoward occurrence in a research subject, which may or may not have a causal relationship with the study intervention/treatment.

An adverse event may be reported at any time during the study, not only during the continuing review phase. The UNLV IRB adverse event reporting plan requires investigators to assess the adverse event and the relationship of the event to the study and report their findings within 5 days directly to OPRS via an Adverse Event Report (AER).

If the study involves sponsored drug, device or biologics studies the investigator is required to report adverse events to the study sponsor and the Food and Drug Administration.

INVESTIGATOR REPORTING PROCEDURES:

It is the responsibility of the investigator to ensure that written notification of adverse events are submitted to OPRS. The principal investigator must complete, with his/her original signature, an Adverse Event Report and attach any additional information necessary in evaluating the report (i.e. medical report).

The IRB relies upon the expertise of the UNLV primary investigator to assess the report. The adverse event report form will require the principal investigator to assess the causality of the event, the seriousness of the event, and whether or not the event was expected and/or related. In addition, the IRB will seek input from the investigators as to if the risk/benefit ratio has been effected due to the adverse event.

IRB REVIEW OF ADVERSE EVENTS: 

In reviewing the adverse event the IRB will consider whether the event effects the risk/benefit ratio to ensure adequate protection of the welfare of subjects. In consultation with the investigator, and as result of the IRB review process, the IRB may:

• Reconsider approval of the study.
• Require the investigator to modify the protocol to minimize risks to subjects.
• Revise protocol to reflect the risks to subjects.
• Require subjects be re-consented.
• Require no additional action on the part of the PI.

ADDITIONAL REPORTING REQUIREMENTS FOR SPONSORED STUDIES:

A written notification of adverse experiences must be submitted to the study sponsor, the Food and Drug Administration (for drugs, devices, and biologics). Details of the reporting requirements are described below. 

1. Adverse events must be reported immediately to the sponsor (except for those events that the protocol or investigator's brochure identifies as not needing immediate reporting). The sponsor protocol should indicate when and how adverse events are to be reported. It is likely that the sponsor will require this immediate report be followed promptly by detailed written reports of the event. Investigators should contact the study sponsor for specific reporting requirements.
2. Pursuant to 21 CFR 312.32, adverse events that are both serious and unexpected must be reported to the FDA. In the case of industry-sponsored protocols, reporting to the FDA is usually accomplished through the normal reporting channel (i.e. investigator to the sponsoring company to the FDA).
3. In the case of investigator-initiated research or research that does not involve funding from a sponsoring company, the Principal Investigator of the protocol assumes the responsibility to report adverse events to the FDA. In such instances, investigators should follow the reporting procedure of the FDA Medical Products Reporting Program (MedWatch). Under the program, adverse events can be mailed, faxed, or reported online. The time requirement for MedWatch reporting varies according to the reporting method used (i.e. mailed, phone, faxed, or online).  Additional information on FDA MedWatch reporting can be obtained from the FDA web site http://www.fda.gov/medwatch/index.html

DEFINITIONS:

Unexpected AE – An adverse event which is unexpected is one for which the specificity is not consistent with any of the following:

• Approved protocol
• Risk information in the consent form
• Reasonably expected natural history and progression of the underlying disease or condition being studied

Serious AE – An adverse event which is serious is one which results in any of the following outcomes:

1. Death
2. A threat to life
3. Inpatient hospitalization or prolongation of existing hospitalization
4. Persistent or significant disability or incapacity
5. Congenital anomaly or birth defect
6. Causes cancer
7. Is an overdose
8. Any medical event which requires treatment to prevent one of the medical outcomes listed above

Related AE- An adverse event which is related to the use of the study drug, device, or intervention is one for which there is a reasonable possibility (e.g. strong temporal relationship) that the adverse event may have been caused by the drug, device, or intervention

Possibly Related AE – An adverse event which is possibly related is one that may have been caused by the drug, device, or intervention, however there is insufficient information to determine the likelihood of this possibility.

Unrelated AE – An adverse event that has seemingly no relationship to the study.