Management and Reporting of Adverse Events (AE), Serious Adverse Events (SAE), Unanticipated Adverse Device Effects (UADE), and Unanticipated Problems (UaP)

Overview

Management and reporting of Serious Adverse Events and other reportable occurrences are an important and critical part of ensuring subject safety. Any adverse effects of a clinical trial, whether thought to be attributable to the research or not, should be documented in the subject’s study records and reported per local and federal regulatory guidelines.

Adverse Events/Serious Adverse Events: AE/SAE reporting guidelines and monitoring plans may vary depending on the needs of each individual clinical trial.  Regardless of what type of guidelines and plans are implemented, it is important for the protocol, eResearch application, and other applicable documents to be congruent with one another. For example, having a study-specific AE reporting plan could reduce over-reporting to the U-M Institutional Review Board Medical School (IRBMED). In this case it would be important for the protocol-specific reporting plan to also be submitted in the eResearch application. Additionally, becoming more familiar with the IRBMED reporting guidelines is useful when submitting AES/SAEs as required (i.e. Continuing Review).

Unanticipated Adverse Device Effects (UADE): In addition to AEs and SAEs, the possibility of Unanticipated Adverse Device Effects (UADEs) must be taken into consideration when conducting research involving devices. It is important to be familiar with local, state, and federal guidelines that pertain specifically to device reporting obligations.

Unanticipated Problems (UaP): Another form of adverse event reporting which applies to all human subjects research, involves Unanticipated Problems (UaPs). Per the UM IRBMED website, “it is a federal and university requirement that investigators of all human subjects research (whether FDA-regulated or not) report to the IRB any ‘unanticipated problems involving risks to the subjects or others' (hereafter referred to as ‘unanticipated problems').” It is important to identify and report UaPs in addition to AEs, SAEs, and UADEs in order to meet reporting obligations and fully protect the rights and welfare of research subjects.

Related Resources

UM Adverse Event Reporting

Unanticipated Problems Involving Risks to Subjects or Other: UaPs

FDA: What is a Serious Adverse Event?

HRPP Operations Manual (OM)

Standard Practice Guideline (SPG) Templates for Clinical Trials

Downloadable Templates and Appendices

AE Reporting.docx

Questions?

Contact us at MICHR-SPGSupport@umich.edu.

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