GCP is an international quality standard that governments can transpose into regulations that decide how clinical trials involving human subjects must be managed. This blog post is a brief introduction to the world of GCP and the video below, which is from our online course Introduction to Clinical Investigation and ISO 14155, deals with the topic as well.
Good clinical practice in the medical device industry
Understanding the GCP principles very well allows for a successful setup and management of clinical studies and collecting data that can stand up to regulatory scrutiny across the globe.
Good clinical practice is defined as
“an ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. It provides public assurance that the rights, safety, and well-being of subjects are protected and clinical data is credible.”
ICH E 6 (R2)
This GCP guideline ensures the ethical and scientific conduct of the study. It should also ensure the protection of human rights for the subjects and volunteers participating in the study. The documentation undergoes rigorous control and includes a clinical study protocol.
It is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data. The protocol also outlines steps for protecting subjects and obtaining quality data.
Clinical study records
GCP required documentation also includes how to set up and maintain documents related to the general records concerning the clinical study, records of how the study staff was trained, the qualification of the clinical site and its facilities, and quality assurance, monitoring, and auditing.
In the context of GCP, one can often see the ICH acronym. It stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The mission of the ICH is to promote public health by achieving greater harmonisation of global drug development. This is done by developing technical guidelines and requirements that can be used by regulatory authorities and the pharmaceutical industry. Harmonisation leads to a more rational use of humans, animals, and other resources, and aims to eliminate unnecessary delays in the development of new therapies.
GCP follows the ICH and enforces tight guidelines on the ethical aspects of clinical research. The ICH GCP document is a unified standard for several regions and countries worldwide, including Europe, Brazil, Canada, China, Japan, and the United States, on how to generate clinical data.
The ISO 14155 standard
The ISO 14155 standard was specifically developed for clinical investigations of medical devices. It is considered to be an excellent tool in helping implement GCP when conducting clinical investigations for medical devices.
The first edition of this ISO standard was published in 2003, the second revision of it in 2011, and the third, and current version of the standard was published in July 2020. Our course is based on the 2020 version of the standard.
The ISO 14155 standard is excellent guidance that should be carefully read and understood since it will almost guarantee that clinical studies with high regulatory compliance and scientific credibility will be set up and conducted.
Similar to ICH-GCP, the ISO 14155 is an international quality standard that governments can transpose into regulations for how to manage clinical investigations with medical devices in human subjects. Both standards also cover the protection of human rights for the subjects in the clinical investigation.
This ISO 14155 standard gives good and detailed instructions on how to set up and perform scientifically authentic clinical studies, focusing on the safety and performance of medical devices while helping the manufacturer understand how to properly document the clinical outcomes and everything else related to the study.
The requirements of ISO 14155 are:
- Create a well-structured and complete clinical investigation plan, the CIP (Annex A)
- Maintain a good organisation of important study documents (records)
- Train the study staff
- Qualify the clinical site and facilities
- Maintain quality assurance
- Perform monitoring and auditing
In conclusion, the purpose and fundamental principles of GCP and ISO 14155 are the same and even overlap, but the difference is in the fact that the ICH-GCP was written for pharmaceutical trials and ISO 14155 was written for medical device investigations.
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Would you like to know more about Clinical Investigation?
Take a look at our online Clinical Investigation for Medical Devices and ISO 14155 course that focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the clinical performance or effectiveness and safety of medical devices.
The course covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents. This practical course is suitable for anyone working in clinical research and medical device development, such as regulatory affairs associates, QA engineers, and clinical research specialists.
Maria Nyåkern, Ph.D., is a consultant, entrepreneur, and B2B service provider in the medical device industry; she is the founder of AKRN Scientific Consulting, a CRO specializing in medical devices and minimally invasive cardiovascular therapies.
Maria is also a valued and respected trainer on clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard. She has vast ‘ hands-on’ experience, having set up and managed dozens of clinical investigations, and tens of thousands of patients, for different medical devices and indications for many of the top ten medical device manufacturers in the industry.