In the context of ICH E6, what does GCP stand for?

In the context of ICH E6, what does GCP stand for?

• A. General Clinical Principles
• B. Good Clinical Practice
• C. Global Compliance Protocols
• D. Guidelines for Clinical Procedures

Answer: (B)

Good Clinical Practice (GCP) is a set of guidelines and principles that ensure the ethical and scientific quality of clinical trials. These standards are internationally recognized and designed to protect the rights, safety, and well-being of trial participants while also ensuring the reliability and credibility of the data collected during research. GCP encompasses various aspects of clinical trials, including the design, conduct, recording, and reporting of studies. It is essential for maintaining the integrity of clinical research and is a fundamental requirement for pharmaceutical companies and clinical research organizations conducting clinical trials. Adherence to GCP is enforced through regulatory requirements and guidelines, making it crucial for anyone involved in clinical research to be familiar with these principles. The other options refer to terms or concepts that are not recognized standards in the context of clinical trials and do not encompass the same scope or significance as Good Clinical Practice.

Good Clinical Practice (GCP) is a set of guidelines and principles that ensure the ethical and scientific quality of clinical trials. These standards are internationally recognized and designed to protect the rights, safety, and well-being of trial participants while also ensuring the reliability and credibility of the data collected during research.

GCP encompasses various aspects of clinical trials, including the design, conduct, recording, and reporting of studies. It is essential for maintaining the integrity of clinical research and is a fundamental requirement for pharmaceutical companies and clinical research organizations conducting clinical trials. Adherence to GCP is enforced through regulatory requirements and guidelines, making it crucial for anyone involved in clinical research to be familiar with these principles.

The other options refer to terms or concepts that are not recognized standards in the context of clinical trials and do not encompass the same scope or significance as Good Clinical Practice.