Regulatory & Documentation
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
ICH E6(R3), finalized in 2025, modernizes the prior R2 framework with explicit emphasis on risk-based quality management, decentralized and digital trial elements, and proportionate documentation. It applies to all ICH region regulators (FDA, EMA, PMDA, MHRA, Health Canada, ANVISA, NMPA, MFDS, Swissmedic).
GCP compliance is verified through sponsor-conducted monitoring and regulator inspections; Form FDA 483 observations and EMA inspection findings drive corrective and preventive action (CAPA) plans.
References
Related terms
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
An Institutional Review Board (IRB) in the U.S. or Independent Ethics Committee (IEC) outside the U.S. is an independent body that reviews and approves clinical trial protocols, informed consent, and recruitment materials to protect the rights, safety, and welfare of human research participants.
Clinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
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