NICHD Adverse Event, Unanticipated Problem, and Serious Adverse Event Reporting Guidance

The purpose of this Guide Notice is to notify the extramural community of NICHD’s guidance for Adverse Event (AE) and Unanticipated Problems (UP) reporting for all research activities and contracts funded in whole or in part by the NICHD.

NICHD expects all clinical research to be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected. Starting with competing applications or newly started protocols for January FY21, the NICHD expects investigators to utilize the newly released NICHD Serious Adverse Events and Unanticipated Problems Guidance. Continue reading →

Last Updated on December 15, 2020