What Is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is an internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants. It ensures the protection of participants’ rights, safety, and well-being, aligning with principles such as those in the Declaration of Helsinki. GCP also ensures the integrity and reliability of trial data, fostering public trust in medical research and regulatory decisions. Compliance is essential for trials supporting drug and treatment approvals globally.
There are a number of recognized standards, regulations, and guidelines governing GCP, the most predominant being ICH E6, which is published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”). The US FDA’s requirements fall under 21 CFR Part 11, 21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, and 21 CFR Part 312, amongst others.
What Is Covered In ICH E6?
The sections of the ICH E6 (R2) / ICH E6 (R3) Guideline:
- 1. Institutional Review Board / Independent Ethics Committee
- 2. Investigator
- 3. Sponsor
- 4. Data Governance – Investigator and Sponsor
- Appendices:
- —- A. Investigator’s Brochure
- —- B. Clinical Trial Protocols and Protocol Amendments
- —- C. Essential Records for the Conduct of a Clinical Trial
What Is Covered In 21 CFR Parts 11, 50, 54, etc?
- 21 CFR Part 11 – Electronic Records; Electronic Signatures – Scope and Application
- 21 CFR Part 50 – Protection of Human Subjects
- 21 CFR Part 54 – Financial Disclosure by Clinical Investigators
- 21 CFR Part 56 – Institutional Review Boards
- 21 CFR Part 312 – Investigational New Drug Application
Who Must Comply with GCP?
Good Clinical Practice (GCP) compliance is required for all parties involved in clinical trials. This includes clinical investigators, sponsors, contract research organizations (CROs), institutional review boards (IRBs), independent ethics committees (IECs), and study personnel. GCP ensures that trials are conducted ethically, the rights and safety of participants are protected, and the data generated is credible and reliable. Compliance is critical for clinical trials intended to support regulatory submissions and approvals worldwide.
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What Type Of Auditing Does GCP Require?
There are a number of different types of audits that can occur to ensure:
- Pre-study audits: Focus on an organization’s ability to conduct the trial.
- Mid-study audits: Review the progress of the trial.
- Post-study audits: Review the data collected.
- Clinical investigator site audits: Assess compliance with the study protocol, GCP guidelines, and regulatory requirements.
- Contract research organization audits: Audit CROs for pre-qualification consideration and post-capability CRO study management.
- Monitoring audits: Focus on the activities of monitors and trial management, including the processes and effectiveness of monitoring participants and results.
Quality Auditing provided ARAMARK with excellent service, highly qualified auditors and an exceptional and comprehensive audit report.
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