Topics Map > Reportable Events

Adverse Event and Other Incident Reporting

Additional topics on the reporting of adverse events, unanticipated problems, new information, noncompliance, protocol exception and deviations

Federal regulations and IRB policy require study teams to submit reportable events to the IRB for review. Reportable events include noncompliance, new information, serious adverse event, and unanticipated problems. Below you will find additional information regarding reporting requirements for each type of reportable events. For a general overview of reporting time frames and examples of reportable events, see the following:

Noncompliance

Noncompliance is defined as the failure to follow (1) federal regulations, state laws or institutional policies relevant to human subjects research, or (2) the requirements and determinations of the reviewing IRB (e.g. failure to follow the study protocol, failure to follow IRB policy, etc.). For information on when noncompliance requires reporting to the IRB, see the following:

Unanticipated Problems and Serious Adverse Events

Unanticipated problems and serious adverse events (SAEs) are types of reportable events that may require reporting to the IRB. SAEs also may constitute an unanticipated problem, depending on the nature of the event. Definitions for each and applicable guidance are below.

An Unanticipated Problem is an event that meets all of the following criteria:

  • Is more likely than not related to the research;
  • Negatively affects the risk/benefit ratio of the research (this includes physical as well as psychosocial risks); AND
  • Was not described in the protocol, Investigator's Brochure, IRB application, or informed consent document OR exceeds the specificity, frequency, or severity described in these documents

A Serious Adverse Event is any of the following:

  • Fatal;
  • Life-threatening
  • Persistent or significantly disabling or incapacitating;
  • An inpatient hospitalization or prolongation of hospitalization;
  • A congenital anomaly or defect; OR
  • A significant medical incident that, based upon appropriate medical judgement, may jeopardize the subject and rquire medical or surgical intervention to prevent one of the outcomes listed above

For information on when SAEs and Unanticipated Problems Require Reporting to the IRB:

New Information

Researchers are expected to report new information to the IRB that affects the risks, benefits, or alternatives to study participation. New Information is a “catch-all” category for identification of unanticipated risks or findings that may affect a subject’s willingness to take part in the study and possibly lead to changes of protocol. For information on what and when New Information requires reporting to the IRB, see the following:

Reportable Events for VA Protocols

VA protocols have different reporting requirements that are typically more stringent than those for non-VA studies. Please see the following for more information on these requirements:

How to Submit Reportable Events

For studies in ARROW:

For studies NOT in ARROW:




Keywords: adverse event, noncompliance, unanticipated problem, new information, protocol exception, deviation, reporting requirements, protocol violation, violation, non-compliance, reportable events   Doc ID: 18324
Owner: Molly L.Group: Health Sciences IRBs
Created: 2011-04-26 19:00 CDTUpdated: 2014-03-26 12:37 CDT
Sites: Health Sciences IRBs