EU CTIS: Europe’s New Clinical Trial Information System

EudraCT has been Europe’s clinical trial database for almost twenty years. But, now it’s the time to say goodbye to EudraCT and hello to the new Clinical Trial Information System (CTIS). CTIS will be the single entry point for submitting, assessing, authorizing, supervising, and reporting clinical trials in all EU Member States (Figure 1).

It is used by academia, commercial and non-commercial organizations, marketing authorization applicants, Member States’ national competent authorities and ethics committees, sponsors, the EMA, the European Commission, and the public to see clinical trial information. The transition to CTIS is ongoing with the last day to transition being 1월 31, 2024.

Needed Revisions of the CTIS System Rules Related to EU CTR Regulation

The new CTIS is the implementation of the European Union Clinical Trial Regulation. This regulation is also known as Clinical Trial Regulation (Regulation (EU) No 536/2014) EU-CTR. You can read about some of the transparency and disclosure requirements of EU-CTR in this blog. The implementation of CTIS was intended to simplify and improve the clinical trial reporting process for investigational medicinal products.

Since CTIS 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.

The EU conducted a survey to gain insight into the problem. The survey’s feedback indicated that the CTIS rules needed to improve the users’ experience and access to information. Thus on 10월 5, 2023, the European Medicines Agency (EMA) revised transparency rules for publishing information on clinical trials submitted through CTIS.

What’s the timeline for clinical trial sponsors to transition to CTIS?

CTIS went live in January 2022 (Figure 2). For a year, sponsors could have submitted clinical trial documentation through either CTIS or EudraCT. This period provided sponsors time to learn about the new system and develop a transition strategy.

On January 31^st, 2023, sponsors must submit all new Clinical Trial Applications through CTIS. By January 31^st, 2025, all ongoing clinical trials transition to CTIS. So, even for studies initiated under EudraCT, there will be a backlog of effort as sponsors shift to CTIS.

Sponsors should consider that completing the Member State procedure can take up to three months. Submit the applications before the transition period ends on 1월 31, 2025!

When possible, member states have agreed on an expedited procedure for transitioning trials to the CTR. For further information, read the CTCG Best Practice Guide.  However, if the transitioning process hasn’t started by November 2024, these projects will be treated as an emergency.

Adapting to a Role-Based System

Biopharmaceutical companies can set up their CTIS accounts as “organization-centric” or “trial-centric.” Large sponsors who conduct frequent, concurrent clinical trials should use the organization-centric approach. Smaller sponsors who conduct fewer, more intermittent trials should choose the trial-centric approach. The chosen approach determines the portal’s user 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 3). 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.

Selecting a Reporting Member State

Within CTIS, 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.

Upon trial initiation, sponsors request their desired RMS through CTIS. So, sponsors should research and request an RMS that is the best fit for their regulatory strategy. Multinational coordination of the assessment process is a positive step in harmonizing EU-based clinical trials.

Centralizing Clinical Trial Submission Information for Regulatory Authorities

Before CTIS, trials were initiated, amended, and completed using Annex forms submitted to multiple scientific and ethical review committees. The CTIS database centralizes and documents all milestones.

Sponsors will also use CTIS for:

• 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, authorities, and the public. With this single source of truth, sponsors also face more pressure to fully understand and utilize CTIS.

__

Are you transitioning to using the CTIS database for European trials? Our experts can help you! We can partner with you for clinical trial registration and results postings. Our team of experts can:

• manage the CTIS process for you,
• provide gap analysis on your current compliance, and
• Help you develop internal SOPs for your future process.

Read our white paper to learn more about EU-CTR and its requirements.

Sources:

EMA Adopts Revised CTIS Transparency Rules // Cooley // Global Law Firm

‘Revised CTIS transparency rules (europa.eu)

Guidance and Q&As – EMA (euclinicaltrials.eu)

CTIS Sponsor Handbook 2023_v.3.03_DRAFT (europa.eu)

Emily McShane originally wrote this blog on 9월 29, 2022. Michele Andrush updated it on 4월 18, 2024.