quick guide to good clinical practice pdf tunw @
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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 internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects. It provides principles and guidelines to ensure the protection of the rights, safety, and well-being of trial participants while also ensuring the validity and credibility of the data collected. The guide typically covers key topics such as informed consent, protocol adherence, data integrity, adverse event reporting, and study monitoring. Following GCP principles is essential for ensuring the integrity and reliability of clinical trial data, which is crucial for regulatory approval and ultimately improving patient care.