Regulatory requirements including the Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP), and European Union (EU) Clinical Trials Directive set forth safety monitoring and reporting responsibilities of sponsors and investigators to ensure the safety and protection of human subjects participating in clinical trials.
THe Division of Microbiology and Infectious Diseases (DMID) relies on investigative sites to provide accurate and thorough initial assessments of adverse events and follow-up secondary to initial reports of these events. DMID has centralized safety reporting through its Clinical Research Operations Management contract. Criteria and reporting procedures are detailed in the clinical protocol. For IND/IDE studies all reporting must comply with 21 CFR 312.32 and 812.150 respectively. Studies conducted outside of the United States must also comply with any local regulations.
* Life-threatening adverse event. An adverse event is considered “life-threatening” if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death. It does not include an adverse event, had it occurred in a more severe form, might have caused death.
Any AE that meets a protocol-defined serious criterion must be submitted immediately (within 24 hours of site awareness) on an SAE form to the DMID Pharmacovigilance contractor at the following address:
Other supporting documentation of the event may be requested by the DMID Pharmacovigilance contractor and should be provided as soon as possible. The DMID Pharmacovigilance contractor will notify the DMID medical monitor and clinical protocol manager.
Last Updated March 17, 2013