Preparing for the CTIS: How the EU CTR Impacts Clinical Trials
The Clinical Trials Information System (CTIS) is established under the European Union's Clinical Trials Regulation (EU CTR). It impacts data management in clinical trials conducted within the European Union (EU) and European Economic Area (EEA).
By January 31, 2025, all ongoing clinical trials approved under the previous Clinical Trials Directive must comply with the new regulation and be recorded in the CTIS. As the deadline looms, some sponsors running clinical trials in the EU and EEA face compliance challenges.
Here’s what to know about the upcoming deadline, how to prepare, and how CTIS impacts current and future clinical trials.
The Advantages of CTIS
According to the EMA’s Sponsor Handbook, CTIS is intended to be the “single-entry point for clinical trials information in the European Union (EU) and in the European Economic Area (EEA).”
Previously, sponsors had to interact with multiple national systems, but now they only need to submit once for all EU member states.
About the Upcoming Deadline
By January 30, 2025, all ongoing clinical trials in the EU must be transferred to the CTIS. This deadline marks the end of the three-year transition period that started when the CTR took effect.
Sponsors with trials running under the previous directive that will continue beyond this deadline must submit a transition application.
The EU recommends submitting transition applications by October 16, 2024 to ensure enough time for review and approval before the final deadline.
Clinical trials that have yet to transition and receive authorization under the EU CTR by the deadline will be non-compliant and cannot proceed.
How to Prepare for CTIS
The CTIS simplifies cross-border trials. However, it also introduces new demands for sponsors, CROs, and study teams regarding regulatory timelines and public access to information.
Sponsors preparing for clinical trials under EU CTR must take specific steps regarding informed consent, data collection, management, integration, and submission to ensure compliance with CTIS.
Adopt standardized data collection methods
Data managers need to ensure that all data is collected according to the standardized formats and protocols required by CTIS.
Standardization involves adopting internationally recognized data standards, such as the Clinical Data Interchange Standards Consortium (CDISC), to ensure consistency and compatibility with regulatory requirements.
Ensure data privacy and informed consent
Study teams need to make sure that data collection processes respect GDPR and other privacy regulations.
Informed consent collected from trial participants needs to cover:
If there are gaps in informed consent based on new CTIS requirements, study teams may need to revise the informed consent form and potentially re-consent participants.
Uphold data quality and integrity
Data managers need to establish robust quality control mechanisms.
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Collected data must be:
They also need to implement regular audits and validation procedures to maintain data integrity throughout the trial lifecycle.
Align with CTIS submission formats
Sponsors must ensure that all clinical trial data is formatted according to the CTIS requirements before submission.
For example, submissions must include specific structured data elements, such as protocol information, safety data, and results. The use of controlled vocabularies and templates will be mandatory.
Establish a submission management process
Study teams need to establish a formal process for managing submissions through CTIS.
Internal workflows to formalize include:
This approach ensures that all data is submitted on time and according to regulatory timelines.
Prepare for real-time updates
Sponsors need to prepare for continuous data submissions and updates rather than a one-time submission process.
This requirement requires having real-time data access and the ability to respond quickly to regulator queries.
Address data anonymization requirements
Since CTIS makes certain trial data publicly accessible, sponsors must ensure that patient data is fully anonymized or redacted before submission.
Sponsors and CROs should prepare systems and protocols for data anonymization to comply with both CTIS and GDPR requirements.
Leveraging EDC for a Competitive Advantage
In order to comply with CTIS requirements, sponsors and CROs should consider moving toward centralized data management platforms. Such systems can consolidate data from multiple trial sites, including those in different countries.
This strategy maintains data consistency and ensures all trial data is easily accessible for submission through CTIS.
Not all systems will necessarily be compatible with CTIS or may use outdated technology that cannot easily interface with CTIS. Lack of compatibility can result in incomplete data transfers, requiring manual intervention to fill gaps, or may necessitate costly upgrades or replacements of legacy systems.
The right Electronic Data Capture (EDC) system ensures data accuracy, traceability, and compliance with Good Clinical Practice (GCP). A good system will also support integration with CTIS for direct data transfers.
Learn more about how Medrio CDMS/EDC can support your studies, or schedule a demo with our team.