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quick guide to good clinical practice pdf
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A quick guide to Good Clinical Practice (GCP) is a concise overview of the principles and guidelines that govern the conduct of clinical trials and research involving human subjects. GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. It ensures that the rights, safety, and well-being of trial subjects are protected and that the data generated is reliable and credible. The guide typically covers key topics such as the importance of obtaining informed consent, the need for ethical review and approval of research protocols, the responsibilities of investigators and sponsors, the documentation and reporting requirements, and the monitoring and auditing of clinical trials. By following GCP guidelines, researchers can ensure that their studies are conducted ethically and that the data collected is of high quality, ultimately leading to advancements in medical knowledge and the development of new treatments and therapies.