Understanding Good Clinical Practice and How to Become GCP Compliant

Good Clinical Practice (GCP) is a globally-renowned ethical and scientific standard that dictates how organizations may design, perform, monitor, and report on clinical trials. The concept got its foundation from the Declaration of Helsinki, a pillar of modern human research ethics.

Governments around the world use this international standard as a framework for designing their medical regulations, particularly regarding:

• The treatment of clinical trial participants
• Ensuring that the results of the trial are scientifically sound and well-documented
• Quality assurance of any drugs or medicinal product the trials help develop

Good clinical practice regulations cover multiple aspects of the clinical trial, ranging from documentation and recordkeeping to facility maintenance, staff training, the use of digital data, and a system of inspections to verify compliance.

And because the World Health Organization formally endorses ICH-GCP guidelines, medical groups worldwide now have a consistent framework to guide their clinical trials and save themselves from redundancies in the development process.

ICH-GCP is a form of good clinical practice from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This standard focuses on 13 primary principles regarding clinical trials.

• A focus on ethics. Clinical trial design must always have ethical principles in mind according to GCP and other regulatory requirements. Check out our course Ethics in Research
• Balancing risk and benefit. All clinical trials come with risks. GCP expects organizations to balance perceived risk with expected benefit when conducting trials.
• The rights of human subjects. The safety of the trial participants takes precedence over other interests.
• Informed medical decisions. In the same vein, any medical decisions or care subjects receive must be from a qualified physician.
• Informed consent. Clinical trial participants must have given full consent before participating in the study.
• Subject confidentiality. Protect the records pertaining to subject identity and medical history carefully.
• Preliminary data on medical products. A trial that tests an investigational medical product must start with the proper clinical and non-clinical information on that product.
• Scientific integrity. A focus on scientifically sound protocols with proper documentation is paramount.
• Using approved protocols. An Institutional review board (IRB) or independent ethics committee (IEC) must approve of the protocol with which the trial complies.
• Staff certification. Staff involved in the medical trial must have the necessary training and experience.
• Data handling. Have proper recording and data storage protocols for handling the information the clinical trial produces. Information is necessary to verify and report on the clinical trial accurately.
• Quality assurance. Have a sufficiently robust quality assurance system to protect the trial’s integrity.
• Good manufacturing practice. Produce and handle investigational products according to GMP standards.

Medical companies aren’t the only participants in a clinical trial study. The clinical trial process involves many stakeholders, all of whom GCP compliance covers.

• The clinical trial sponsor is the organization that conducts the clinical trial. It provides funding and management.
• The investigator is the leader of the team responsible for undergoing the actual trial processes.
• Pharmacists are on-site to maintain and store investigational products (namely test drugs).
• Patients are the human research participants .
• Regulatory authorities from governments around the world review clinical data and conduct inspections to verify GCP compliance.
• Committees also exist to review the ethical treatment of test subjects.

GCP is a general term for ethical standards that apply to conducting clinical trials, but there may be different interpretations of the concept. The FDA’s GCP framework might be slightly different from the World Health Organization’s, for instance.

The aforementioned International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or ICH, bridges the gap between the pharmaceutical industry and regulatory authorities for designing and controlling medical studies. The ICH promotes public health through its global standards known as ICH-GCP.

But while ICH-GCP primarily handles the American, European, and Japanese regions, another standard exists from the World Health Organization known as WHO-GCP published in 1995.

Both the WHO and ICH variations experienced similar development cycles by similar experts, but they differ in format and content. ICH is primarily a regulatory standard, while WHO is more of an informative resource, especially for countries without currently existing regulatory standards.

Knowledge of good clinical practice is mandatory for safe and scientifically sound clinical trials. Any organization in drug development and research and anyone involved in clinical trials must understand GCP guidelines and follow their primary principles.

Learn everything you need to know about GCP compliance through CfPIE’s course: GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials.

Register today to equip your clinical trial staff with the experience they need to meet international standards.