After almost twenty years with EudraCT, it’s time to say goodbye to Europe’s old clinical trial database and embrace the new Clinical Trial Information System (CTIS). CTIS will be the single-entry point for submitting, assessing, authorizing, supervising, and reporting a clinical trial in all Member States of the EU (Figure 1). It will be 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 new CTIS is the implementation of the European Union Clinical Trial Regulation, also known as Clinical Trial Regulation (Regulation (EU) No 536/2014) EU-CTR (read about some of the transparency and disclosure requirements of EU-CTR in this blog). Any time regulatory mandates change, sponsors can expect a steep learning curve and an increased workload. However, in the long run, implementation of CTIS is intended to simplify and improve the clinical trial reporting process. During the transition period, it’s important that sponsors understand the main changes associated with CTIS.
What is the timeline for compliance with the transition to CTIS?
CTIS went live in January of 2022 (Figure 2). For a year, sponsors can submit clinical trial documentation under either the new CTIS or the outgoing EudraCT. This period provides sponsors time to learn about the new system and develop a transition strategy.
Starting on January 31st, 2023, all new Clinical Trial Applications must be submitted through CTIS. And, by January 31st, 2025, all ongoing clinical trials must be transitioned to CTIS. So, even for trials initiated under the old system, there will be a backlog of effort as sponsors shift to the new database.
Source: https://www.ema.europa.eu/en/documents/newsletter/clinical-trials-information-system-ctis-highlights-august-2021_en.pdf
Adapting to a Role-Based System
CTIS offers a choice for how companies set up their account, between “organization-centric” and “trial-centric”. The organization-centric approach is meant for larger sponsors who are running frequent, concurrent clinical trials. The trial-centric approach is best for smaller sponsors who run fewer, more intermittent trials. The chosen approach determines user permissions in the portal.
With the organization-centric approach, a sponsor selects one high-level internal administrator, who creates and assigns roles for every trial (i.e., “clinical trial administrator,” “Part 1 Preparer,” “Part 2 submitter,” etc.) (Figure 3). Assigning these roles can be an administrative burden, but a role-based system allows uniform oversight and security across trials. For the trial-centric approach, each distinct trial can be created and managed by a different administrator. This may be a more agile process, but trial-centric companies should have stringent SOPs to ensure there are no duplication of efforts or inconsistency in approach across trials.
Sources are https://www.ema.europa.eu/en/documents/other/quick-guide-clinical-study-reports-submission-ctis-training-programme-module-13_en.pdf and https://www.ema.europa.eu/en/documents/presentation/presentation-trial-centric-organisation-centric-approach-ctis-sme-academia-clinical-trials_en.pdf
With either approach, a third-party vendor or contract research organization (CRO) cannot fully manage the CTIS for the sponsor. However, strategically assigning roles to service providers can help reduce the administrative burden on your internal team.
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 assessment for the trial.
Upon trial initiation, sponsors request their desired RMS through CTIS. So, sponsors should research and request an RMS that will be 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
Before CTIS, trials were initiated, amended, and completed using Annex forms submitted to multiple scientific and ethical review committees. Within CTIS, all milestones will be centralized and documented in the database.
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 to 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.
As you start to develop a transition plan for using the CTIS database for European trials, don’t hesitate to reach out to our experts for support. 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 collaborate with you to develop internal SOPs for your future process. Click below to learn more and to contact us.
