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What does GCP standards refer to in the context of clinical research?

General Commercial Practices

Good Clinical Practice

Good Clinical Practice (GCP) standards refer to a set of internationally recognized ethical and scientific quality standards that guide the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. GCP ensures that the clinical trial is conducted in such a way that the rights, safety, and well-being of trial subjects are protected and that the clinical data generated are credible and accurate.

The principles of GCP are rooted in several key regulatory documents, including the Declaration of Helsinki and guidelines set forth by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the International Conference on Harmonisation (ICH). By adhering to GCP, researchers and institutions contribute to the reliability of clinical research, ultimately helping to ensure that new therapies are safe and effective for public use.

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Guideline for Clinical Proposals

Global Compliance Policies

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