Reportable Events Help

Adverse Event, Protocol Deviation and Regulatory Noncompliance Reporting Information

Please refer to the Event Reporting Investigator Guideline for information regarding serious and non-serious adverse event, protocol deviation, and regulatory non-compliance reporting information.


Unanticipated Problem Reporting Information

Please refer to the Unanticipated Problem Investigator Guideline for examples related to and reporting information for Unanticipated Problems.