📘 Regulations: Good Clinical Practice (GCP) and Clinical Trials

Good Clinical Practice (GCP) is an international ethical and scientific standard for designing, conducting, monitoring, recording, auditing, analyzing, and reporting clinical trials that involve human subjects. These regulations ensure that:

• Rights, safety, and well-being of trial participants are protected.

• Clinical trial data are credible and accurate.

• Sponsors and investigators meet their legal and scientific responsibilities.

🌐 Key Regulatory Frameworks and Guidelines

1. ICH-GCP (E6[R2]) – International standard used across the EU, US, Japan, and other ICH member countries.

2. FDA Regulations (21 CFR Parts 11, 50, 54, 56, 312) – U.S. laws governing clinical trials.

3. EU Clinical Trial Regulation (EU CTR 536/2014) – Unified system for conducting clinical trials across EU countries.

4. UK Clinical Trial Regulations – Post-Brexit adaptation of EU rules, overseen by MHRA.

5. WHO Guidelines for GCP – Used by non-ICH countries and global health research bodies.

6. National Ethical Guidelines (e.g., ICMR in India) – Local requirements for ethics and human subject protection.

⚖️ Core GCP Principles

• Informed consent

• Protocol compliance

• Investigator qualifications

• Ethics committee (IRB/IEC) oversight

• Quality assurance and monitoring

• Recordkeeping and data integrity

🔎 Enforcement and Oversight

• Regulatory inspections (FDA, EMA, MHRA, etc.)

• Audits by sponsors or CROs

• Ethics committee reviews

• Investigator accountability

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