Regulatory & Documentation
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.
GCP compliance is a regulatory requirement in every ICH region and a contractual requirement in virtually all sponsor; site agreements. The current revision, ICH E6(R3), modernizes GCP for risk-based and decentralized trials and replaces the prescriptive R2 framework with a quality-by-design approach.
GCP applies to all parties: sponsors, CROs, investigators, IRBs/ECs, and increasingly to technology vendors processing trial data. Failure to demonstrate GCP compliance during regulatory inspection is a leading cause of submission delays.
Related terms
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.
Informed Consent Form (ICF)
An informed consent form (ICF) is the document a clinical trial participant signs after a documented informed-consent discussion confirming they understand the study's purpose, procedures, risks, benefits, alternatives, and their rights as a research participant.
ICH M11 (Common Protocol Template)
ICH M11 is the international harmonized standard, published by the International Council for Harmonisation, that defines a Common Protocol Template (CPT) and machine-readable Technical Specification for clinical trial protocols.
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