Good Clinical Practice (GCP)
An international quality standard for the design, conduct, recording, and reporting of clinical trials. GCP ensures that trial data are credible and that the rights, safety, and wellbeing of participants are protected. All clinical trials supporting peptide drug approvals must comply with GCP.
Technical Context
ICH E6(R2) GCP covers: institutional review board responsibilities, investigator qualifications and obligations, sponsor responsibilities, clinical trial protocol requirements, investigator's brochure content, essential documents, and quality management systems. Key GCP principles: trials should be scientifically sound, protection of participant rights/safety/wellbeing takes priority over science/society, adequate preclinical evidence must support clinical use, protocols must be reviewed by ethics committees, informed consent is essential, every participant must be under qualified medical care, adverse events must be reported, data must be accurately recorded and verifiable against source documents, and participant confidentiality must be maintained. GCP inspection by regulatory authorities verifies compliance and data integrity.