Reporting of Safety Information
Tremendous diversity exists among adverse event reporting requirements promulgated by various Federal agencies, as well as among the NIH Institutes. This heterogeneity is a challenge for investigators, IRBs, and sponsors, who may face multiple requirements regarding the content, format, and timing of reports that must be made to different agencies and oversight bodies.
The NIH is undertaking a set of initiatives to improve understanding and compliance with these requirements, as well as to optimize the use of adverse event data, by catalyzing the harmonization of requirements at a trans-federal level.
An important mechanism for achieving these goals is the Federal Adverse Event Task Force (FAET ), an interagency body composed of representatives of the National Institutes of Health, Food and Drug Administration, Office for Human Research Protections, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, the Department of Defense, and the Agency for Healthcare Research and Quality. The purpose of the FAET is to propose specific means for promoting harmonized and streamlined requirements and processes for reporting of adverse events in clinical research. Toward this end, the FAET is conducting a comprehensive, in-depth assessment and analysis of existing federal policies for adverse event reporting, discerning how agencies collect and use these data in promoting the safety and integrity of their clinical research activities, and identifying opportunities for greater interagency harmonization.
To address the diversity of requirements that exist within the NIH, a Trans-NIH Adverse Event Task Force has been established and charged with proposing ways to harmonize the reporting policies of the agency's many Institutes and Centers.
Pertinent Resources, Policies, and Regulations
Department of Health and Human Services:
Food and Drug Administration:
National Institutes of Health:
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