Clinical trials involve people, and people deserve protection. Good Clinical Practice is the international ethical and scientific standard for designing, conducting, recording, and reporting trials. It is not a law, but regulators expect compliance, and trials that ignore it are unlikely to be accepted. The standard covers everything from how participants are recruited to how data are stored and how adverse events are reported.

GCP rests on a few principles. Trials should be scientifically sound and ethically justified. Participants must give informed consent. Their rights, safety, and well-being take priority over the interests of science and society. Data must be accurate and verifiable. The trial must be approved by an ethics committee and overseen by qualified investigators. Sponsors must monitor the trial and ensure that any problems are identified and corrected. The International Council for Harmonisation publishes the GCP guideline, known as E6, which regulators in the US, EU, and Japan have adopted.

Core requirements:

• Informed consent. Participants understand risks and agree voluntarily.
• Ethics oversight. An institutional review board or ethics committee approves the protocol.
• Data integrity. Records are accurate, complete, and verifiable.
• Safety reporting. Adverse events are documented and reported promptly.
• Investigator qualifications. Trained, experienced staff conduct the trial.

GCP training is mandatory for investigators and study staff. Certificates expire and must be renewed.