Good clinical practice (GCP)
GCP is an international quality standard that governments can transpose into regulations that decide how clinical trials involving human subjects must be managed.
Good clinical practice in the medical device industry
It is important to understand the GCP principles very well since it will allow you to successfully set up and manage clinical studies and collect 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 clinical study documentation undergoes rigorous control and includes a clinical study protocol, or clinical investigation plan (CIP). This 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.
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 the current version of the standard was published in July 2020.
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, 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 organization 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.
Would you like to know more about Clinical Investigations?
We can support you with setting up clinical investigations according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents. Moreover, our clinical expert team can help you to design your clinical investigation successfully according to the device type and clinical development stage.
If you want to learn more, you can check Introduction to Clinical Investigation and ISO 14155 which 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.
Subject Matter Expert
Maria Nyåkern, Ph.D., Medical Device Executive LinkedIn