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.
Steps to prepare for CTIS include:
- Adopt standardized data collection methods
- Ensure data privacy and informed consent
- Uphold data quality and integrity
- Align with CTIS submission formats
- Establish a submission management process
- Prepare for real-time updates
- Address data anonymization requirements
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.
To learn more about data standardization methods and CDISC, explore this eBook on designing a clinical trial database.
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:
- Data sharing
- Increased transparency requirements under CTR
- Potential public accessibility of certain data
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.
Interested in implementing eConsent to improve informed consent processes? Explore this eConsent implementation best practices blog.
Uphold data quality and integrity
Data managers need to establish robust quality control mechanisms.
Collected data must be:
- Accurate
- Complete
- Free of inconsistencies or duplications
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:
- Document preparation
- Quality checks
- Submission tracking
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.
How CTIS Impacts Data Management in Clinical Trials
The new centralized online platform affects data management for clinical trials conducted within the EU and EEA.
CTIS impacts clinical trial data management by:
- Promoting transparency and public access
- Standardizing formats and protocols
- Improving data quality and integrity
Curious how other successful organizations train internal teams for data standardization? Learn what Roche Diagnostics recommends in this clinical trial data standardization blog.
Transparency and public access
CTIS is designed to promote transparency in clinical trials. This system makes certain data, including trial results and information on safety issues, accessible to the public.
💡Data managers need to anonymize and redact sensitive data properly before submission to meet these transparency requirements while ensuring patient confidentiality.
Standardized formats and protocols
CTIS enforces standardized data submission formats for data. This approach makes it easier for regulators and sponsors to manage and assess clinical trial data uniformly across multiple member states.
💡Data managers need to adapt to these standard formats to ensure compatibility and compliance with the CTIS framework.
Data quality and integrity
Sponsors are required to ensure that submitted data is accurate, complete, and adheres to GCP guidelines. The CTIS platform facilitates real-time monitoring and validation of data, improving overall data quality and integrity.
💡Data managers need to use rigorous data validation processes and quality control to meet CTIS 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.
Medrio CDMS/EDC improves data quality and regulatory readiness through:
- Data quality and edit checks
- Validation environment and three-tier build environment
- Audit trails
- Built-in monitoring workflows
- Configurable roles and permissions (down to the variable level)
It also supports efficient data exports. Flexible export options within the live instance of customers’ studies promote on-demand data access and exports of real time study data when they are needed.
CTIS impacts data management in clinical trials by promoting centralized, standardized and transparent data handling. These requirements call for enhanced compliance and quality control measures. Sponsors can prepare for future submissions through CTIS by choosing a robust EDC to support their needs.
Learn more about how Medrio CDMS/EDC can support your studies, or schedule a demo with our team.
Frequently Asked Questions (FAQ)
The EU Clinical Trial Information System (CTIS) is a centralized online platform introduced by the European Medicines Agency (EMA) under the European Union’s Clinical Trials Regulation (EU-CTR 536/2014). It serves as the single entry point for the submission, assessment, and supervision of clinical trials conducted in the European Union (EU) and European Economic Area (EEA).
Yes, CTIS is replacing the EudraCT database. EudraCT was the primary system for managing clinical trial data under the old Clinical Trials Directive (2001/20/EC), but it is being phased out as part of the transition to the new Clinical Trials Regulation (EU-CTR).
Countries not affected by the EU Clinical Trials Regulation (EU-CTR) include Norway, Iceland, and Liechtenstein. While these countries are part of the European Economic Area (EEA), they are not directly part of the European Union (EU) and have different regulatory frameworks. Additionally, the United Kingdom also does not fall under EU CTR due to Brexit.
EU CTD (Clinical Trials Directive) refers to the Clinical Trials Directive (2001/20/EC), the old framework for regulating clinical trials in the EU. It focused on ensuring the safety and ethical standards of trials but was criticized for creating fragmented national systems. EU-CTR (Clinical Trials Regulation) refers to the EU Clinical Trials Regulation (EU 536/2014), which replaced the EU CTD. It harmonizes the application, assessment, and supervision processes for trials across EU member states, providing a centralized system (CTIS) for submissions.