Navigating ICH E6 (R3) changes for GCP excellence with a digitalised QMS process

In the realm of clinical research, adhering to Good Clinical Practice (GCP) through the ICH E6 guidelines has become an essential part for global compliance. Those contemplating the integration of a modern, digital Quality Management System (QMS) or updating an existing one for clinical research must be aware of the changes introduced in the third revision (R3) for Data Governance. These adjustments should be implemented before the finalisation of Annex 2 in the summer of 2024.

At Rephine, our expertise lies in guiding you through these adaptations, ensuring data integrity in your systems, anticipating challenges in regulatory compliance, and refining areas of your QMS development to align with GCP.

To facilitate your readiness for digitalisation updates within your practices while maintaining high GCP standards in accordance with the new ICH E6 guideline, we’ve crafted this concise guide to keep you ahead of the changes and be confident in your processes.

What is ICH E6, and how does adherence to its guidelines influence clinical trials?

ICH E6 establishes a global benchmark for GCP, addressing ethical and scientific dimensions of trials.

It promotes a universal approach across ICH regions, ensuring mutual acceptance of clinical data by regulatory authorities.

Adherence to ICH E6 creates a comprehensive framework for trials, fostering global consistency, ethical conduct, scientific rigour, and a culture of quality, ultimately ensuring patient safety and regulatory compliance.

Why is the ICH E6 (R3) draft an essential adaptation?

The R3 draft, released for public consultation in May 2023 and finalising by the end of this year, aims to adapt, harmonise, and modernise accepted best practices since its previous adaptation in 2016.

ICH E6 (R3) enhances clarity and readability, emphasising the integration of a quality culture into clinical trials and drug development.

This draft aims to empower clinical teams, enhancing trial efficiency,
and upholding data integrity and patient safety throughout the trial lifecycle.

What key area has been refined in ICH E6 (R3) related to digitalisation?

Significant changes have been made to the Data Governance chapter, with a restructuring of sections to enhance guidance on data integrity, traceability, and security. The chapter contains the following sectors:

4.1 – Safeguard Blinding in Data Governance

4.2 – Data Life Cycle Elements

4.3 – Computerised Systems

4.4 – Security of Computerised Systems

4.5 – Validation of Computerised Systems

4.6 – System Failure

4.7 – Technical Support

4.8 – User Management

What does the new Data Governance structure mean for computerised processes?

The updated Data Governance structure guides investigators and sponsors in managing data integrity, security, and traceability throughout clinical trials. Emphasising the use of computerised systems, the chapter highlights digitalisation benefits for precise reporting, verification, and interpretation of trial-related information, supported by robust procedures across the entire data lifecycle.

Within Data Life Cycle Elements (4.2), a specific focus on Data Capture (4.2.1) and Relevant Metadata Including Audit Trails (4.2.2) ensures that crucial logs of acquired data, including relevant metadata from any source, should be controlled for accurate analysis. These detailed logs are essential for preserving the integrity of critical data, controlling risks, and ensuring well-documented acquisition. 

For computerised systems, maintaining records is more straightforward due to their inherent purpose and capacity to handle data efficiently. In contrast, adhering to paper-based processes may lead to inefficiencies in managing metadata and audit trails, posing concerns such as human error or compromised data confidentiality. This makes these approaches less suitable for meeting the GCP standards outlined in the ICH E6(R3) draft. A computerised or digitised system not only ensures compliance but also provides a more effective and streamlined approach to managing all data in clinical trials.

Embracing digitalisation offers robust solutions for enhancing data protection, ensuring reliable trial results, enforcing clearer decision making, and facilitating future adaptations.

Here are our 4 key advantages to implementing ICH E6 (R3) Data Governance through a digitised QMS platform


Elevated Data Governance in Blinded Trials

Integrating guidelines from the Data Governance chapter (4.1) assures the integrity of blinding in trial systems. By implementing a QMS system based clinical trial lifecycles, can encompass design, user management, and data access, with a focus on preventing unintentional unblinding and documenting the impact of planned or unplanned instances.


Optimised Management of the Data Life Cycle

Adhering to the updated Data Life Cycle Elements (4.2) establishes robust procedures for data capture with time stamping, metadata handling, data review, corrections, transfer, and finalisation pre-analysis. Having a digitalised QMS guarantees the reliability and quality of trial data through documented processes throughout its life cycle.


Secured and Validated Computerised Systems

Aligning with guidelines on Computerised Systems (4.3, 4.4, 4.5) ensures clear procedures, security controls, and risk-based validation processes. Implementing a QMS that can prioritise user training, system security, data backup, and validation enhances the security, reliability, and consistency of trial data.


Efficient Technical Support and User Management

Following recommendations for Technical Support and User Management (4.7, 4.8) establishes mechanisms for issue management and periodic reviews to address systemic concerns. Integral access controls on a QMS can limit system access to authorised users, ensuring user-friendliness without compromising security.


The integration of ICH E6 (R3) Data Governance through a computerised system or digitised QMS, enhances navigation in the evolving landscape of clinical research. Utilising a modernised system offers significant benefits, seamlessly implementing the full ICH E6 (R3) with enhanced usability, functionality, and adaptability to future improvements in clinical trials and research.

This approach ensures that your clinical trial processes adhere to global standards systematically, enhancing trial efficiency and maintaining the highest levels of data integrity and patient safety throughout the trial lifecycle.

Partnering with Rephine's
QMS Team for efficient digitalisation

Our QMS team is ready to assist companies seeking an efficient QMS while aligning with GCP and ICH E6 guidelines.

Whether you’re aiming to enhance your clinical trial management with a tailored QMS digitalisation transformation or updating your existing digital QMS, our team of experts is here to help. We work on identifying your priorities and areas for improvement in data integrity, security, and functionality.

Explore more about our QMS services and get in touch with our experts by visiting our QMS Advisory page.

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