Starting today, July 24, the Training Environment of the Clinical Trials Information System (CTIS), run by the European Medicines Agency (EMA), enters a new phase. The Agency’s goal is clear: bring the training experience closer to that of Production, strengthening the security and traceability of user accounts.
For sponsors, CROs, and professionals who rely on this environment to train their teams before operating in CTIS Production, these changes are far from a minor technical detail. They directly affect access, account management, and how training trials are handled. At PVpharm, we’ve been closely following this transition for months so we can support our clients without disruptions, and that’s why we want to summarize the key points here.
An Access Model More Aligned with Production
Until now, the Training Environment worked with its own logic, based on fictive accounts that made testing easier but didn’t reflect how CTIS Production actually works. With today’s update, the EMA takes a decisive step toward a unified model:
- Login: users now access the Training Environment in exactly the same way as CTIS Production.
- Multifactor authentication (MFA): it is now mandatory in the Training Environment as well, reinforcing access security.
- The updated CTIS Training Environment uses personal, traceable accounts instead of generic fictive accounts.
It is important to note that, following this transition, users should expect to start working with newly created, personal and traceable accounts, and existing training data may no longer be available.
How to Request Access: The New “Training Access Role”
Whether you already had an account in the Training Environment or you’re accessing it for the first time, the procedure changes and now goes through EAM Test (register-test.ema.europa.eu).
- New users:
- Register in EAM Production (register.ema.europa.eu), following the same process used to access CTIS Production.
- Keep in mind that the new training role can only be requested one day after completing that registration.
- Existing Production users: Can reuse their Production account to access the Training Environment, provided they first request the new role.
In both cases, the final step is the same:
- Log in to the EAM Test portal and open the menu from the icon in the upper left corner of the landing page.
- Go to the “Add Access” tab and use the search field to find the role “CTIS Training Environment Access.”
- Add the role, review the request, and confirm it.
Without this specific role, access to the Training Environment won’t be possible, so we recommend teams plan ahead rather than leave it until the last minute, especially before training sessions or when onboarding new profiles.
Specific Steps for Sponsor Users
The EMA has defined a dedicated path for sponsor users, and it’s worth keeping in mind:
- EAM Production account: the starting point is always the Production account, not a training-specific account.
- Required access: must be requested by following the updated guidance and section 6.2.3 of the Sponsor Handbook.
- Sponsor workspace: sponsor users work exclusively with sponsor accounts within the sponsor workspace of the Training Environment.
- CT-centric account approach: access to functionalities is organized around the training trials created by each user, who acts as the administrator of those trials.
- Interaction with Member States: if a sponsor needs to simulate interaction with national authorities, this must be arranged separately, by contacting the relevant national contact points for clinical trials directly.
New Annual Safety Report (ASR) Module in CTIS
Alongside these access changes, the EMA is introducing a new Annual Safety Report (ASR) module in CTIS, representing an important step in the digital management of annual safety reports. This is a significant update for safety and pharmacovigilance teams managing clinical trials, as it changes the usual workflow for handling ASRs within the system.
Given the scope of this change, the EMA is stepping up specific training on the new module, and we recommend all sponsors carefully review the available guidance before ASR submission moves exclusively to this new functionality.
Why Getting Ready Now Matters
This redesign is not just a facelift: it represents a real change in how access works and how teams operate within the CTIS Training Environment. Organizations that don’t adapt their internal access management processes in time may find their training teams blocked, face delays onboarding new users, or struggle to properly prepare for ASR submission.
At PVpharm, we support sponsors, CROs, and regulatory affairs departments with end-to-end CTIS management: from setting up access and roles to training teams and providing operational support for trial submissions and safety reporting. Staying on top of every EMA update is part of our daily work, so you can focus on what really matters: your clinical trials.
Need help adapting your processes to the new CTIS Training Environment or preparing for the ASR module? Contact us and we’ll help you make the transition smoothly.
