GCP is an international quality standard that governments can use to create legislation that controls how clinical trials involving human beings must be conducted.
In the medical device sector, good clinical practice is essential.
Understanding GCP principles thoroughly enables the effective creation and administration of clinical investigations, as well as the collection of data that can withstand global regulatory scrutiny.
This GCP guideline guarantees that the study is conducted in an ethical and scientific manner. It should also defend the human rights of the subjects and volunteers taking part in the study. The paperwork is subjected to stringent scrutiny and contains a clinical trial procedure.
It is a document that describes the research objectives, methodology, techniques, assessment kinds, data collecting dates, and statistical considerations for data analysis. The protocol also describes how to protect people and collect high-quality data.
Clinical study data
GCP documentation also covers how to set up and maintain general clinical study records, records of how the study personnel was educated, qualification of the clinical site and its facilities, and quality assurance, monitoring, and auditing.
The ICH abbreviation is frequently seen in the context of GCP. It is an acronym that stands for the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The ICH’s objective is to enhance public health by promoting greater global drug development standardization. This is accomplished by providing technical standards and criteria that regulatory agencies and the pharmaceutical sector may employ.
GCP adheres to the ICH and imposes stringent criteria on clinical research ethics. The ICH GCP document provides a single standard for numerous areas and nations throughout the world on how to generate clinical data, including Europe, Brazil, Canada, China, Japan, and the United States.
ISO 14155 is an international standard
The ISO 14155 standard was created primarily for clinical evaluations of medical devices. It is regarded as a great instrument for assisting in the implementation of GCP while conducting clinical trials for medical devices.
The first edition of this ISO standard was issued in 2003, the second revision in 2011, and the third and most recent revision in July 2020. Our training is based on the standard’s 2020 revision.
The ISO 14155 standard is great guidance that should be carefully studied and understood since it nearly guarantees the establishment and conduct of clinical trials with high regulatory compliance and scientific credibility.
The ISO 14155, like the ICH-GCP, is an international quality standard that countries can use to create legislation for how to administer clinical trials involving medical devices in human beings. Both guidelines address the protection of human rights for clinical research subjects.
This ISO 14155 standard provides good and detailed instructions on how to set up and conduct scientifically authentic clinical studies, with a focus on the safety and performance of medical devices, while also assisting the manufacturer in understanding how to properly document clinical outcomes and everything else related to the study.
ISO 14155 specifies the following requirements:
- Make a well-structured and comprehensive clinical investigation plan (CIP) (Annex A)
- Keep key study documents well organized (records)
- Qualify the clinical location and facilities by training the study staff.
- Maintain quality control.
- Conduct monitoring and auditing
Finally, the goal and core concepts of GCP and ISO 14155 are similar and even overlap, but the distinction is that the ICH-GCP was designed for pharmaceutical trials, whereas ISO 14155 was written for medical device inquiries.
