In today’s entry, we explain the importance of ICH GCP in clinical research. ICH-GCP (International Conference on Harmonization– Good Clinical Practice) is an internationally recognized standard of regulations that covers all scientific and ethical aspects of a clinical trial before, during and after a clinical trial. .
ICH-GCP – Meaning
Specifically, ICH GCP addresses the following topics:
- Clinical trial planning
- Conducting clinical trials
- Monitoring for quality assurance in clinical studies
- Auditing for legally compliant implementation
- Documentation of the study data
- Statistical and biometric evaluation of test results
- Assessment of adverse events associated with a study and drug side effects.
- Reporting on the entire course of the clinical trial
The ICH-GCP guidelines serve the purpose of ensuring patient safety and quality in clinical trials.
What does ICH mean?
The abbreviation ICH-GCP refers to the ICH Efficacy Guideline E6. It includes regulations for the development, approval and safety assessments of drugs. The regulations were drawn up in 1996 by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Go to ICH E6 R2 Guideline.
Since when are the ICH GCP guidelines valid?
The ICH-GCP guidelines came into force in 1996 and have been continuously developed since then. They are based on the Nuremberg Code, which was formulated after the Second World War following the Nuremberg Trials, and on the the Declaration of Helsinki which was first adopted at the 58th General Assembly of the World Medical Association (WMA) in 1964.
ICH-GCP paved the way for the ethical foundations of Good Clinical Practice in the European Union since 1989. Nevertheless, states continued to have their own clinical research guidelines with serious implications for patient safety. Moreover, the research results of the clinical trials were not comparable across countries. Until the adoption of the ICH-GCP guidelines in 1996, no uniform, international standards for clinical trials existed.
ICH GCP: current version and ICH GCP E6 R3 Guidelines
Since 2016, the revised ICH E6 R2 Guideline for Clinical Trials has applied. An update to the ICH E6 R3 Guideline is currently being developed. More information about the Guidelines, the status of the revision and the affiliated Member States can be found at the official ICH website at .
What is GCP – Good Clinical Practice?
GCP stands for Good Clinical Practice. GCP is a guide to international ethical and scientific quality standards in clinical trials. The GCP guideline applies to all persons involved in a study. In addition to patient safety, GCP ensures that data and results from clinical trials are valid and reproducible.
Goals of the ICH GCP Guideline
At the heart of the ICH GCP regulations are the rights of subjects and the protection of their integrity and identity. Personnel involved in studies have a fundamental obligation to perform tasks in a respectful, compliant, professional and efficient manner. Employees of contract research organizations and study sites, sponsors, ethics committees and regulatory authorities are subject to GCP regulations and must act in accordance with the principles of Good Clinical Practice. ICH-GCP also applies for investigators and study nurses, as well as employees in laboratories where blood and tissue samples are collected and analyzed. Pharmacies where drugs or investigational medications are stored, imaging centers, and radiology practices must also comply with GCP guidelines.
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Our training consultant provides helpful guidance on which course meets the requirements for your professional situation. The specifications of the German Medical Association for the curriculum for GCP training are taken into account by the training consultant.
What is a GCP course?
A GCP course teaches the ethical, legal, and administrative framework for clinical research. It includes the basics of the Declaration of Helsinki and ICH GCP, explains the tasks of an investigator and provides information on current legislation and guidelines. The recommendations on the details and content of the courses are given in the current Curriculum of the German Medical Association . Before working in clinical trials, it is essential to complete an ICH-GCP course. A valid GCP certificate is mandatory for participation in clinical trials. This ensures that all standards and ethical principles, sound science, and clear, detailed protocols are followed during the study. Here you will find Information on our GCP courses.