The International Council for Harmonisation (ICH) has released an updated version of the Good Clinical Practice (GCP) guidelines — ICH E6(R3). The new version emphasizes the following key areas:
- Quality by Design:Proactive identification and management of key risks to participant safety and data reliability.
- Data Governance:A new section dedicated to data integrity and traceability across all stages of the data life cycle.
- Flexibility:Adapting the guidelines to new study types and sources of data.
The new guidelines will come into effect on July 23, 2025, giving sponsors and investigators time to align their processes with the new requirements.
Key changes include:
1. New Guideline Structure:
The guidelines will be divided into three main sections:
General Principles: 11 detailed GCP principles replacing the previous 13, with a focus on flexibility and proportionality in clinical research approaches.
Annex 1: Specific guidelines for traditional interventional clinical trials.
Annex 2: Additional guidance for non-traditional trial designs, such as decentralized studies and those utilizing real-world data (RWD).
2. Strengthening the Risk-Based Approach
Zwiększony nacisk na identyfikację i zarządzanie krytycznymi czynnikami wpływającymi na jakość badań (Critical to Quality Factors), co ma na celu zapobieganie błędom mogącym podważyć wiarygodność wyników badań. Wprowadzenie koncepcji „Acceptable Ranges” zamiast sztywnych limitów tolerancji jakości (Quality Tolerance Limits), co pozwala na większą elastyczność dostosowanie do specyfiki badania.
3. Data Governance
The new section dedicated to data management highlights the importance of data integrity and quality, especially in the context of the growing use of digital technologies and remote data collection methods.
4. Facilitating Innovative Approaches to Clinical Trials
The guidelines take into account modern methods of conducting studies, such as decentralized, pragmatic, and real-world data (RWD)–based trials.
They provide recommendations for the ethical and efficient conduct of these innovative study designs.
5. Increasing Patient Engagement and Diversity in Clinical Trials
Sponsors are encouraged to clearly define inclusion and exclusion criteria, taking into account population diversity.
This aims to improve the generalizability and relevance of clinical trial results.
6.Simplifying Adverse Event Reporting Requirements
The updated guidelines remove the requirement for individual submission of all suspected unexpected serious adverse reactions (SUSARs) to ethics committees.
This change is intended to streamline reporting processes and reduce administrative burden.
7. Clear Definition of Roles and Responsibilities
The revised guidance emphasizes the need for clear documentation and assignment of roles and responsibilities in clinical research.
Particular attention is given to oversight by sponsors and investigators, especially in the context of the increasing involvement of third-party service providers and technology vendors.
Sources:
ICH E6 R3 Guideline on GCP – Summary of Proposed Changes > ICH E6 R3 Guideline on GCP – Summary of Proposed Changes | Clinical Trials Toolkit
Summary
These updates aim to streamline research processes and ensure the highest ethical and quality standards in clinical trials. It is essential that all stakeholders remain aware of the upcoming changes and adequately prepare for their implementation.
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