Good Clinical Practice (GCP) per ICH E6(R3) — Principles & Responsibilities

Global Regulatory Framework for Clinical Research

Clinical research is one of the most heavily regulated activities in healthcare. Understanding the regulatory landscape is essential for CRCs, as non-compliance can result in warning letters, clinical holds, site disqualification, and even criminal penalties.

Key Regulatory Bodies

• ICH (International Council for Harmonisation): Brings together regulatory authorities and pharmaceutical industry to create harmonized guidelines. ICH-GCP (E6) is the foundational document for clinical trial conduct worldwide.
• FDA (U.S. Food and Drug Administration): Regulates clinical trials in the United States under 21 CFR Parts 11 (electronic records), 50 (informed consent), 56 (IRBs), 312 (IND for drugs), and 812 (IDE for devices).
• EMA (European Medicines Agency): Coordinates drug evaluation and regulatory activities across EU member states. Implements the EU Clinical Trials Regulation (CTR) 536/2014.
• INVIMA (Colombia): Instituto Nacional de Vigilancia de Medicamentos y Alimentos — regulates clinical trials per Resolution 2378 of 2008.
• COFEPRIS (Mexico): Comisión Federal para la Protección contra Riesgos Sanitarios — regulates clinical research per the General Health Law and NOM-012-SSA3-2012.
• ANVISA (Brazil): Agência Nacional de Vigilância Sanitária — oversees clinical trials under RDC 9/2015.

Key Regulatory Documents

• ICH-GCP E6(R3): The latest revision of GCP guidelines, emphasizing risk-based approaches, quality by design, and sponsor oversight proportionate to risks.
• 21 CFR Part 11: FDA requirements for electronic records and electronic signatures — critical for EDC systems.
• EU CTR 536/2014: Streamlined regulation for clinical trials across EU member states, with a centralized submission portal (CTIS).