Regulatory Compliance and Human Subjects Protection Branch (RCHSPB)

The Clinical Safety Office

• Reviews draft protocols, informed consents, and case report forms and provides recommendations regarding information on the risks of a study; the management, collection, and reporting of adverse events (AEs) and serious adverse events (SAEs); NIAID Data and Safety Monitoring Board (DSMB) and Safety Monitoring Committee requirements; and the basic and additional elements of informed consent
• Evaluates SAEs for regulatory reporting requirements, communicates with sites, drafts and distributes investigational new drug (IND) Safety Reports, and provides line listings and other reports as requested
• Reconciles SAE data for IND annual reports and ensures that SAEs included in site line listings have been reported to the Clinical Safety Office according to the protocol and that the AE terms used are appropriate and consistent
• Oversees data monitoring committees (Safety Monitoring Committee—DSMB)