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  1. Center for Drug Evaluation and Research | CDER

Good Clinical Practice

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations. These laws and regulations are intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects.

The following resources are provided to help investigators, sponsors, and contract research organizations who conduct clinical studies on investigational new drugs comply with U.S. law and regulations covering good clinical practice (GCP).

 General Information

 Institutional Review Boards (IRBs)

FDA Regulations

 Sponsors, Monitors, and Contract Research Organizations

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