Adverse Events Reporting
Adverse event reporting to the IRB, and in some circumstances, Federal agencies and the Sponsor, is required by Federal regulation. The UMASS IRB has established the following policies and procedures for the reporting of adverse events as a means of ensuring that the risks and benefits relationship to subjects participating in research studies remains acceptable, and the consent form contains information necessary for subjects to make an informed decision about their participation or continuation in a study.
Adverse event reporting requirements differ depending on the nature of the study. Significant Adverse Events (SAE), as described by the IRB Guidelines for Reporting Significant Adverse Events, require submission of the SAE Report Form. Events that do not fit into the SAE definition should be listed on the Event Tracking Log and submitted with the continuing and final report.
Forms and Guidelines
- Adverse Event (AE) Report for an e-Protocol Submission
- Event Tracking Log
- Adverse Event Reporting Decision Tree
- IRB Guidelines for Reporting Significant Adverse Events
For more information, please contact:
Human Research Protection Office (HRPO)
110 Research Administration Building
70 Butterfield Terrace
University Of Massachusetts
Amherst, MA 01003-9242
Phone: (413) 545-3428
FAX: (413) 577-1728