The European clinical trials landscape is undergoing a significant transformation with the transition from EudraCT to the Clinical Trials Information System (CTIS). This shift, driven by the European Union’s Clinical Trials Regulation (CTR), is set to enhance both the efficiency and transparency of clinical trials across member states.
For Sponsors operating clinical trials in Europe, this transition presents new challenges and opportunities, specifically regarding data transparency, redaction, and anonymization. With an upcoming effective date of January 31, 2025, Sponsors need to act now.
Transitioning from EudraCT to CTIS
EudraCT has long served as a cornerstone for managing clinical trials in Europe, but its features for transparency were somewhat limited. On the other hand, the new CTIS introduces advanced areas that are aimed at bridging these transparency gaps.
One of the most significant improvements is CTIS’ centralized platform, which integrates clinical trial submissions and assessments while also enhancing transparency. This means that clinical trial data will be much more accessible to stakeholders (i.e., researchers, regulators, and the public), and it builds greater trust and accountability in clinical research.
Several key documents need to be redacted or anonymized before being made publicly accessible through CTIS, including:
- Clinical Study Reports (CSRs)
- Informed Consent Forms (ICFs)
- Investigator’s Brochure (IB)
- Protocol and Protocol Amendments
- Summary of Clinical Trial Results for Laypersons
- Safety Reports
- Responses to Regulatory Authority Queries
- Inspection Reports
Sponsors must carefully review these documents to ensure that all sensitive information is adequately redacted before submission and public release.
One major aspect of this transition from EudraCT to CTIS involves new clinical study protocols for redaction and anonymization. CTIS mandates rigorous redaction processes to protect sensitive information. Sponsors must ensure that personally protected information (PPI) data, company confidential information (CCI), and other sensitive elements are appropriately redacted or anonymized before submission, as these documents will now be posted to the public.
According to a RAPS.org news report, the “EMA has advised Sponsors to submit their applications to the CTIS portal as soon as possible and noted at a recent meeting that Sponsors have moved only 20% of clinical trials to the new platform.”
Impact on Clinical Trial Sponsors
The transition from EudraCT to CTIS brings several implications for clinical trial sponsors. While the new system promotes greater transparency, it also requires Sponsors to navigate the complexities of redacting and anonymizing clinical trial documents and data. This may lead to additional administrative tasks and necessitate enhanced data management strategies.
Compliance with CTIS’s transparency standards is essential for avoiding regulatory issues. Sponsors will need to familiarize themselves with the new guidelines for data submission and ensure that all clinical trial-related documents meet the system’s requirements. This might involve significant operational adjustments, including training staff on the new system’s functionalities and updating internal processes.
To comply with the new CTIS requirements, Sponsors will need to adopt robust redaction and/or anonymization practices, or hire a third-party partner, like TrialAssure, to support
Zach Weingarden, Director Production Solutions at TrialAssure, shares that “Anonymization is often preferred over redaction because it allows for the sharing of valuable data without compromising privacy or confidentiality. While redaction involves obscuring specific sensitive information, which can limit the usefulness of the data, anonymization adjusts personal identifiers in a way that helps prevent the identification of individuals yet preserves the data’s integrity and utility for analysis. This makes anonymized data more versatile, enabling information access and use by external parties without exposing personal details or confidential business information.”
The CTIS deadline is near
The transition from EudraCT to CTIS has been a phased process, with a gradual rollout across member states over the last few years.
However, according to the European Medicines Agency (EMA), “The transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation (CTR) is open to sponsors from the day of the entry into application of the CTR, on 31 January 2022, until the end of the 3-year transitional period, on 30 January 2025, without the need to discontinue a clinical trial or put a trial on hold.”
Sponsors should ensure that both ongoing and new trials are managed through CTIS by this date. Additionally, the European Medicines Agency (EMA) and other regulatory bodies will continue to provide updates and guidance throughout the transition period, so staying informed about any changes or additional requirements is crucial.
“With about five months left on the CTIS deadline, many Sponsors do not realize that they only have two months left to make the transition. This is because it normally takes two to three months to transition from EUDRA CT to CTIS,” said Himanshu Kumar Singh, Senior Manager at TrialAssure.
Singh continued, “After this October, all Sponsors should have clear anonymization processes and plans in place to avoid delays with the EMA.”
Review revised CTIS rules from the EMA here.
Learn more about anonymization technology solutions to address the new CTIS requirements.
