Good Clinical Practice (GCP)

ICH-GCP (E6 guideline, most recently revised as E6(R2) and E6(R3)) provides a unified standard accepted by regulatory agencies in the US (FDA), EU (EMA), Japan (PMDA), and many other countries. The 13 core principles include: trials should be conducted according to the Declaration of Helsinki, the rights and safety of participants take priority over science and society, IRB/IEC approval is required, informed consent must be obtained, and data must be recorded accurately. GCP defines three key roles: the Sponsor (funds and initiates the trial, responsible for overall quality), the Investigator (conducts the trial at the site, responsible for participant care and data accuracy), and the Monitor (representative who verifies that the trial is conducted properly — source data verification, protocol adherence, safety reporting). Essential documents include: the investigator's brochure, the protocol, informed consent forms, case report forms (CRFs), drug accountability logs, and regulatory correspondence. GCP compliance is verified through audits and inspections by regulatory agencies. Non-compliance can invalidate trial data, resulting in rejection of drug applications, warning letters, or criminal penalties.