Impact assessment is the first, critical step to updated ICH GCP compliance

The release of the final ICH Good Clinical Practice (GCP) E6(R3) guideline marks a significant milestone in the evolution of global clinical research standards.

With its sweeping structural and content changes, E6(R3) introduces a more adaptive and proportionate framework for clinical trial design and conduct.

However, the complexity and breadth of these updates present a formidable challenge for sponsors and stakeholders. At the heart of successful implementation lies a foundational step: a comprehensive impact assessment.

An impact assessment is not merely a regulatory checkbox exercise. It is the cornerstone of strategic compliance. The E6(R3) guideline emphasises a proportionate, risk-based approach across all aspects of clinical trial operations, from data integrity and participant protection to technology use and system readiness.

To align with this vision, organisations must begin with a detailed impact assessment, which serves as a diagnostic tool to identify gaps between current practices and the new requirements.

The scale of the GCP updates requires significant depth and rigour to achieve an effective impact assessment.

The R2 and R3 guidelines, including both draft and final versions, must be compared line by line before evaluating each change from multiple operational perspectives, including systems, processes, personnel, budgets and more.

In an impact assessment, each identified impact is rated for severity and likelihood, with corresponding mitigation strategies documented. This level of granularity ensures that no aspect of the organisation is overlooked and that implementation plans are both targeted and efficient.

During the comprehensive review, five main areas of impact called for focused attention:

1. Risk-based quality management
2. Expanded role of technology
3. Investigator responsibilities and qualifications
4. Participant protection
5. Collaboration and data-sharing.

Beyond internal alignment, a cross-functional impact assessment also facilitates transparent collaboration between sponsors and service providers – now inclusive of CROs under GCP’s updated stakeholder categories.

CROs with a detailed impact assessment and implementation strategy can foster a shared understanding of the changes and harmonise compliance efforts with sponsor partners.

This kind of partnership model is essential for agile, study-specific adaptations, especially during the transition period when ongoing studies may require protocol amendments to meet R3 standards.

The impact assessment is the first critical step in implementing E6(R3) compliance. It provides the clarity, structure and foresight needed to navigate the complexities of the new guideline. However, it’s not a one-time exercise.

As global implementation of E6(R3) progresses, organisations must maintain dynamic oversight and regularly update their action plans. Proactive reviews and strategic updates to SOPs and processes ensure continuity without disruption to sponsor programmes.

By investing in a robust impact assessment at the front and fostering cross-functional collaboration, sponsors and service providers can achieve compliance and strengthen the integrity and innovation of their clinical research programmes.