The U.S. Code of Federal Regulations (CFR) defines procedures and requirements governing the use of investigational new agents regulated by the U.S. Food and Drug Administration (FDA), including the monitoring and reporting of serious adverse events (21 CFR 312). The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) provides clinical research funding and often serves as an Investigational New Drug (IND) application sponsor. NIAID/DAIDS is responsible for ensuring that its supported and/or sponsored research is conducted in accordance with the above regulation, other applicable CFRs, and both FDA and International Council on Harmonisation (ICH) guidance documents.
The Manual for the Expedited Reporting of Adverse Events defines which adverse events (AEs) must be reported in an expedited manner to DAIDS to fulfill its regulatory obligations as a sponsor. This manual applies to all DAIDS-supported clinical trials, unless the responsibility for expedited adverse event (EAE) reporting has been delegated to another entity.
All protocols that require EAE reporting should follow: Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0 - January 2010)
Previous versions are available upon request at DAIDSRSCSafetyOffice@tech-res.com