Good Clinical Practice (GCP) is an international, ethical, scientific, and quality standard for the conduct of trials that involve human participants. It ensures that the safety and well-being of trial participants are protected; that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the clinical trial results are reliable.
The new draft of ICH GCP E6 (R3) was released for public consultation in May 2023 and it sets up the new requirements for good clinical practices in modern-time clinical trials. For example, in the Investigator section relating to Informed Consent of the trial participants, there have been several important changes, such as adding the emphasis on the importance of the information being sufficiently clear to help the patients’ understanding, including new technologies that could be used such as remote aspects and electronic signatures. The Sponsor’ section was significantly changed. In the Agreements’ part the aspects of relationships between parties involved in clinical trial and delegating of activities are brought together. The section on Contract Research Organisations (CRO) has been removed, and the requirements are now contained in the Sponsor section under the “Service provider”, the new term that is now used.
The new guideline introduces the Quality Management System (QMS), emphasizing the QMS implementation to ensure the quality of clinical trials. This includes risk management, monitoring, and continuous improvement.
There are substantial changes regarding the Data Quality and Integrity, and the guideline emphasizes the merit of data quality and probity, and the requirement for systems to ensure them.
Full text can be reviewed at: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-e6-r3-guideline-good-clinical-practice-gcp-step-2b_en.pdf
Vladimir Seredyuk, GCT QA Director commented: New guidelines respond to the drug development industry’s innovations in clinical trial types and data sources. Following these standards will help the industry to create more efficient trials with enhanced patient safety, improved data quality, and regulatory compliance, resulting in safe, reliable, and effective medicines for patients.