Health Sciences Institutional Review Boards

Adverse Events, Noncompliance & Incident Reporting

Adverse Events

The UW-Madison Health Sciences IRBs have developed a set of guidelines that addresses the reporting of adverse events that occur on FDA-regulated trials. For adverse events that occur on studies that are not FDA-regulated, see the Unanticipated Problems, Incident, and New Information Reporting section below. Separate reporting guidelines for studies involving investigational devices have been developed because the reporting requirements for these trials are unique. Below are guidance, resources, and forms to help researchers and others identify when and how to report adverse events to the IRB.

• Reporting requirements for studies involving INVESTIGATIONAL DEVICES

• Reporting requirements for studies INVOLVING OTHER INVESTIGATIONAL AGENTS, including INVESTIGATIONAL DRUGS

• Adverse Event Reporting Decision Guide
• Serious Adverse Event Reporting Form
• Adverse Events Reporting Log
• Adverse Event Reporting Guidelines Letter for Sponsors (coming soon!)

• Office for Human Research Protections Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
  (http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm)

Unanticipated Problem, Incident, and New Information Reporting

Researchers are expected to report new information affecting the risks, benefits, or alternatives to study participation or any incident, experience, or outcome that constitutes an unanticipated problem involving risks to subjects or others. Below are guidance, resources, and forms to help researchers and others identify when and how to report an incident, experience, or outcome to the IRB.

• UW-Madison Guidance for Reporting Unanticipated Problems

• Office for Human Research Protections Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
  (http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm)

• Unanticipated Problem, Incident, and New Information Reporting Form and Instructions
  • Form
  • Instruction

Noncompliance, Protocol Violation, and Deviation Reporting

Federal regulations require the reporting of serious and continuing noncompliance to the IRB, institutional officials and certain federal agencies and department heads. Noncompliance is any 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. Below are guidance, resources, and forms to help researchers and others identify when noncompliance has occurred, what should be reported to the IRB, and how reports are made.

• UW-Madison Guidance for Reporting Noncompliance
• Self-Report of Potential Noncompliance Form and Instructions
  • Form
  • Instructions
• Health Sciences IRBs Protocol Exceptions and Deviations Policy