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NHLBI Adverse Event and Unanticipated Problem Reporting Policy
The purpose is to describe the National Heart, Lung, and Blood Institute (NHLBI) extramural programs’ policy and procedures for adverse event (AE) and unanticipated problem (UP) reporting.
This policy applies to all human subjects research funded in whole or in part by NHLBI extramural programs.
Sponsor: The Food and Drug Administration
(FDA) regulations define the sponsor of a
clinical trial (21
CFR 50.3) as the person or entity who
initiated the trial. NIH guidance elaborates on the definition and
4.0 POLICY AND PROCEDURES
All human subjects research supported by NHLBI must include procedures for identifying, monitoring, and reporting all AEs, including both serious (SAE) and non-serious events, and UPs. All NHLBI human subjects research will follow a uniform policy, which is based on the FDA/Office for Human Research Protections (OHRP) regulations and guidance including definitions and timelines, as outlined in Sections 4.2 and 4.3.
4.2 Reporting Procedures and Requirements
Procedures for identifying, monitoring, and reporting AEs and UPs must be described in the study's Institutional Review Board (IRB)-approved data and safety monitoring (DSM) plan that is submitted to the NHLBI (see NHLBI Data and Safety Monitoring Policy). AE and UP reporting should include at a minimum:
A monitoring person or body, such as a Data and Safety Monitoring Board (DSMB), may require additional expedited reporting. The program official will confirm with the principal investigator that any UP has been reported to the appropriate IRBs and that all corrective action/preventative action plans have been adequately implemented.
4.3 Reporting Timelines and Guidance
SAE and UP Event Reporting Timelines
is appointed by the sponsor; for example, DCC,
For additional information contact the NHLBI Program or Program Official associated with your study. Questions and comments regarding this policy may be directed to Katharine Cooper-Arnold, Office of Clinical Research, NHLBI.
For questions and/or
concerns regarding the content of this
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Last Updated: November 2013