Adverse Event/ Unanticipated Problem Reporting

General Information

Investigators conducting research with human subjects should familiarize themselves with the Adverse Event and Unanticipated Problem Procedures outlined below. The Principal Investigator must provide all key personnel with procedures and contact persons in case of an adverse event.

Adverse Event Reports are required during the duration of the study and up to 30 days after the study has been completed (unless otherwise noted by the IRB). After 30 days, the Adverse Event Reports are no longer required for submission to the IRB unless the study meets one of the three criteria below:

  • Study has closed but follow ups are still being done with patients
  • The initial study involved something that could potentially have long term side effects
  • The investigator is required to report the Adverse Event to funding agencies

Investigators are asked to report all unanticipated problems and adverse events to the IRB for review regardless if the investigator considers the event as being unrelated to the subject’s participation in the study.  The IRB will review the event and determine if there is a direct relation to the study and will also determine if changes need to be made to the study as a result of the event.
Submitting a Report

Complete the Event Form (Interim Review Form), which is accessible within the online TOPAZ Electronic Protocol Submission System. The Event Form is used for reporting Adverse Events, Unanticipated Problems, and Protocol Deviations. Serious events (by definition) need to be reported by the PI within 5 business days, while non-serious events are to be reported within 10 business days of the occurrence.

A research project that has been identified as requiring data and safety monitoring must utilize the Adverse Event Table to keep track of all reported Adverse Events.

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment Form, Renewal Form, or Event Report Form for the same project). For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Adverse Event or Problem, it is advised to first contact the IRB Office to see if your pending submission is almost ready for approval. If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IRB Coordinator via email. The IRB Office will later import the contents of the Event Form into the TOPAZ system on your behalf.

Definitions for Reporting

Serious Event: An adverse event that is fatal or life threatening, permanently disabling, requires or prolongs hospitalization, or results in significant disability, congenital anomaly, or birth defect.

Non-Serious Event: An adverse event that does not meet the definition of a serious event.

Unanticipated Event: An adverse event that has not been previously observed or is not consistent in nature, severity, or frequency with existing risk information, such as in the investigator brochure, research protocol, consent form, or other available information (e.g., IND application for an investigational drug).

Related to the Study: Associated or having a timely relationship with; a reasonable possibility exists that an outcome may have been caused or influenced by the event in question (e.g., administration of a study drug), although an alternative cause/influence may also be present. Related events may be definitely, probably, or possibly related.

Unrelated to the Study: Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question.
Contact Information

In the event that a research related injury or adverse event occurs, the investigator needs to notify the Office of Research Integrity. In addition, if a research subject feels that they have sustained injury or their rights have been abused, please contact the IRB Office or the IRB Chairperson immediately for guidance. If the injury is research related and medical care is warranted, the PI will be advised on how to proceed. For questions or further guidance, please contact the Office of Research Integrity at 305-348-2494.