EU CTIS: 欧州の新しい臨床試験情報システム

The CTIS system is part of the European Union Clinical Trial Regulation. This regulation is also known as Clinical Trial Regulation (Regulation (EU) No 536/2014) or EU-CTR. The CTIS submission process was designed to simplify and improve the clinical trial reporting process for investigational medicinal products, addressing transparency and disclosure requirements outlined in EU CTR approval timelines. The European Medicines Agency (EMA) maintains CTIS and the public website, together with the EU Member States, EEA countries and European Commission.

Since CTIS EU launched in 2022, deferral serviceability has proven to be complex from an information management and data security perspective. When deferrals were applied, it caused confusion among drug manufacturers.

One of the key changes under the updated rules is the removal of the deferral mechanism, which previously allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect commercially confidential information.

The updated rules strike a balance between transparency of information and protection of Commercially Confidential Information (CCI). They benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early. They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data.

The new version of the CTIS public portal displays data and documents on clinical trial applications submitted on or after 18 June 2024, in line with the timelines defined in the revised transparency rules. Moreover, the total number of trials that are publicly available will increase substantially.

By 2025年1月31日, all ongoing clinical trials transitioned to CTIS, even those originally initiated under EudraCT. Sponsors were responsible for ensuring a smooth shift to CTIS EU while managing compliance with new regulatory requirements.

Now that the transition is complete, all EU clinical trials must adhere to the EU CTIS. Sponsors must conduct submissions, updates, and regulatory communications exclusively through CTIS EU.

CTIS is a role-based system that enables users to perform different actions depending on the permissions attached to the roles assigned to them by a user from their organization with administrator permissions.

With the organization-centric approach, a sponsor selects one high-level internal administrator. This person creates and assigns roles for every clinical trial. Examples of these roles include “clinical trial administrator,” “Part 1 preparer,” “Part 2 submitter,” etc. (Figure 2). Assigning these roles can be burdensome, but a role-based system allows uniform oversight and security across trials.

For the trial-centric approach, different administrators can create and manage each trial. This may be a more agile process. However, trial-centric companies should have stringent SOPs to prevent duplication of efforts or inconsistency in approach across trials.

With either approach, a third-party vendor or contract research organization (CRO) can’t fully manage a sponsor’s CTIS. However, strategically assigning roles to service providers can help reduce your team’s administrative burden.

Within CTIS EU, sponsors can now request a Reporting Member State (RMS) to review clinical trial data submissions. Rather than sponsors collating assessments and responses from multiple countries, the designated RMS will coordinate trial assessments.

Now that CTIS is fully implemented, sponsors must ensure they select the RMS that best aligns with their regulatory strategy. This multinational coordination simplifies the approval process and allows for greater harmonization across EU-based clinical trials.

Before the EU CTIS, trials were initiated, amended, and completed using Annex forms submitted to multiple scientific and ethical review committees. The CTIS now centralizes all trial milestones and documentation, including:

• Submitting annual safety reports
• Adding new member states to ongoing trials
• Receiving agency feedback and assessment information
• Responding directly to agency requests for information
• Uploading redacted and anonymized trial details for the general public to view

Having more activities centralized in a single database is simpler for sponsors, regulatory authorities, and the public. With this single source of truth, sponsors also face more pressure to fully understand and utilize the CTIS.

Our experts can help! We provide CTIS services to support clinical trial registration and results postings. Our team can:

• Manage the CTIS process for your organization
• Conduct a gap analysis on your current compliance
• Develop internal SOPs for ongoing regulatory adherence