U.S. Food and Drug Administration Center for Drug Evaluation and Research |
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Drug Applications |
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Information for Clinical InvestigatorsIntroductionClinical trials represent the ultimate premarket testing ground for unapproved drugs. During these trials, an investigation compound is administered to humans and is evaluated for its safety and effectiveness in treating, preventing, or diagnosing a specific disease or condition. The results of this testing will comprise the single most important factor in the approval or disapproval of a new drug. Although the goal of clinical trials is to obtain safety and effectiveness data, the overriding consideration in these studies is the safety of those in the trials. CDER monitors the study design and conduct of clinical trials to ensure that people in the trials are not exposed to unnecessary risks. This website provides guidance for conducting clinical trials with
investigational drugs and information for compliance with the regulations of the Food and
Drug Administration. For clinical investigators who are not familiar with FDA
regulations and the guidance that the Agency provides for good clinical practice, there
are two sources of information which investigators should read first. Federal Regulations for Clinical Investigators contains Code of
Federal Regulations pertaining to the responsibilities of clinical
investigators. The second source of information for new clinical investigators is Guidance for Industry: Good Clinical
Practice Consolidated Guideline.
FDA/Center for Drug Evaluation and Research |