Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve human subjects. GCP ensures that the rights, safety, and well-being of trial participants are protected and that the clinical trial data are credible and accurate.
Key Principles of GCP:
- Ethical Conduct: Trials must be conducted according to ethical principles and respect for the rights and dignity of participants.
- Informed Consent: Participants must be fully informed about the trial and provide voluntary consent.
- Protocol Compliance: Trials must follow a predefined protocol approved by ethics committees and regulatory authorities.
- Data Integrity: Accurate and verifiable data collection, storage, and analysis must be ensured.
- Quality Assurance: Ongoing monitoring, auditing, and reporting to maintain high standards and compliance with regulatory requirements.