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Clinical Research Regulatory Bodies

Clinical research regulatory bodies are organizations responsible for overseeing the conduct and management of clinical trials to ensure they are conducted in a safe and ethical manner. Some of the key regulatory bodies include:

  1. The U.S. Food and Drug Administration (FDA), which regulates clinical trials in the United States and is responsible for ensuring the safety and effectiveness of drugs, medical devices, and other treatments.
  2. The European Medicines Agency (EMA), which regulates clinical trials in the European Union and is responsible for the scientific evaluation, supervision, and safety monitoring of medicines.
  3. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA), which regulates clinical trials in Japan and is responsible for evaluating the safety and efficacy of drugs and medical devices.
  4. The World Health Organization (WHO), which provides guidelines and standards for ethical conduct of clinical trials and helps to coordinate international clinical trial efforts.
  5. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which provides guidance on the conduct of clinical trials and the development of pharmaceutical products.

These regulatory bodies work to protect the rights and welfare of clinical trial participants, ensure the validity and reliability of trial results, and advance medical knowledge through clinical research.

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