IRB (institutional review board)
An independent ethics committee that reviews and approves research involving human subjects. IRB approval is required before any clinical trial can begin, ensuring participant safety and ethical conduct.
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Related Terms
The process by which a patient voluntarily agrees to medical treatment or participation in a clinical trial after being fully informed of the risks, benefits, and alternatives.
Clinical trial phasesThe staged process of testing a new drug in humans: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale confirmation), and Phase 4 (post-marketing surveillance). Each phase has specific objectives and requirements.
IND (investigational new drug)An application submitted to the FDA before human clinical trials can begin. The IND includes preclinical data, manufacturing information, and the proposed clinical trial protocol.