Ensuring Your Organization is Prepared for the Implementation of the EU Clinical Trial Regulation

Experts share how organizations can prepare to execute their clinical trials under the EU Clinical Trial Regulation.

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities. The updated regulation is now the mandatory regulatory framework for which new applications for interventional and low interventional clinical trials in the EU must be assessed and authorized. Ongoing trials must transition to the EU CTR by Jan. 30, 2025.

Managing the preparation and submission of a clinical trial application means being compliant with the requirements of the EU CTR, as well as ensuring that staff, systems and processes are effective. Planning and executing initial trial submissions and transitioning existing active trials will require cross-functional team input to set the strategy. Changes to an organization’s infrastructure include:

• Day-to-day activities of employees
• Modifications to clinical trial management systems, standard operating procedures (SOPs) and work instructions (WI)
• Cross-functional training
• Clinical trial operations (e.g., outsourcing models, user management of the Clinical Trial Information System, transparency, management of modifications and regulatory intelligence gathering)

Implementing these changes may prove to be challenging initially and will require workarounds, as the European Medicines Agency (EMA), industry and national member states adapt with the evolution of the EU CTR landscape. However, a structured two-phase approach and cross-functional action plan to implement and manage the changes is recommended to fully prepare organizations to deliver their trials under the EU CTR. (The two phases can run in series, with some Phase 2 work initiated prior to the final completion of Phase 1.)

Phase 1 : EU CTR impact analysis

• Develop a project charter to document goals, scope, constraints and boundaries, risks, and milestones.
• Determine impacted functions and agree on selecting representatives from each function as part of a cross-functional EU CTR workstream.
• Facilitate the creation of a process map, including current state and future state processes.
• Analyze the impact of the EU CTR on employees across the impacted functions, current systems and processes.
• Use a gap analysis as a basis to generate an implementation map. (e.g., identify functions that require training, SOPs or WIs to be produced or updated, or systems and processes that require changes).

Phase 2: Implementation

• Implement the solutions to the gaps identified in Phase 1. This will include the implementation of cross-functional training, a change management plan, authoring of SOPs and updates to system functionalities.

Five keys to success your company should implement prior to the EU Clinical Trial Regulation

The top recommended solutions to ensure readiness for the EU CTR include:

1. Implementation of a cross-functional workstream:

• Creating an executive steering committee to serve as an escalation pathway; a cross-functional core workstream consisting of sub-workstream leads to allow alignment on decisions made; and sub-workstreams to drive the activities and meet the set milestones.

2. Effective training and change management strategy:

• Developing a strong comprehensive training program.
• Implementing a change management strategy.
• One-to-one hypercare support from subject matter experts to allow for robust adaptation to the changes.

3. Determining transparency requirements:

• Allowing information to become publicly available except for quality related information (Investigational Medicinal Product Dossiers) and financial arrangements.
• Planning a strategy to balance transparency requirements with business interests.
• Ensuring high quality trial documentation, minimizing the inclusion of commercially confidential information (CCI) and personal protected data where possible.
• Being prepared to identify CCI and personal protected data for redaction to prevent disclosure.

4. Systems and process readiness:

• Creating and/or updating SOPs and work instructions, defining your organization’s new roles and responsibilities mandated by the new regulation.

5. Maintenance of regulatory intelligence:

• Staying abreast of the evolving regulatory landscape.

The EU CTR brings major changes in the way organizations need to be structured and how clinical research will be planned, conducted and documented. Following this phased implementation approach will ensure your organization can continue to manage clinical research in the EU.

The Regulatory Intelligence Policy and Advocacy group at the PPD clinical research business of Thermo Fisher Scientific serve as a liaison between our local affiliates and subject matter experts to ensure that we can provide the most current regulatory intelligence as the EU CTR landscape evolves.

Get your organization ready for changes that the EU CTR is bringing.