Good Clinical Practices in PharmaceuticalsEdition 1

Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable.

1. Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted.
2. Provides the most up‑to‑date and best practices, techniques, and methodologies in good clinical practice.
3. Discusses applicable laws and regulations supporting GCP compliance, quality and operations.
4. Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.