The multiple steps involved in the transition to CTR

| by Naomi Krikman

There is a lot for sponsors to think about before they can even start transitioning their clinical trials to the Clinical Trial Regulation (CTR) and accessing the various portals.

First, there are practicalities of how they will manage their ongoing studies to ensure they are suitable to transition to CTR.

While this is something most large sponsors are well aware of, these steps can be a challenge for universities or smaller sponsors. However, after 30 January 2025, every study that’s ongoing or any new study will need to be conducted under the CTR, and therefore in the Clinical Trial Information System (CTIS).

Which trials are impacted?

Any studies approved under the Clinical Trial Directive and that still have at least one active site in the European Union or the European Economic Area as of the final transition date will need to transition. An active site is defined as one where a last patient visit has yet to occur or some activity defined in the protocol is still ongoing after the deadline.

In addition, clinical trials that have been temporarily halted – for example, for safety reasons – will need to transition to the CTR if they are restarted.

Managing the admin logistics

Some of the questions we commonly get asked concern setting up the EMA account in order to be able to access the CTIS and the portals sponsors need to register on, including the Organisation Management Service (OMS) and EudraVigilance.

• OMS – regardless of whether you are outside or within the EU, you must register your organisation for the OMS before transitioning your trial over to CTIS

• EudraVigilance – in order to add your studies to CTIS you need a EudraVigilance number, so you must have that set up before registering with CTIS

You will also need to ensure you have an administrator within the OMS as well as CTIS. Sponsors can choose whether to adopt an organisation-centric user management approach or a trial-centric approach to their CTIS administrator. The former would make more sense for those sponsors transitioning multiple studies, whereas for tiny organisations with single studies, a trial-centric approach may be more appropriate.

Resource-intensive process

From our experience, sponsors often overlook the time and the resources that need to be dedicated to the setup on CTIS and other portals. It’s important that you carefully identify a resource who will take responsibility for managing and maintaining all these various accounts and who will have access to these.

While you can outsource some of these responsibilities – for example, have your clinical research organisation (CRO) take responsibility for managing the data in CTIS – as the sponsor you remain responsible for managing the access and rights of all users across all clinical trials in CTIS.

Furthermore, it’s important to consider the limitations that outsourcing to a CRO brings. Once your contract with your CRO finishes, which will likely be before you have submitted your clinical trial study reports or clinical trials summaries, you will suddenly be in a position where the person or persons who were accessing the system on your behalf are no longer available. That means you will need to plan for the end of the study and how the CTIS administration will be handled going forward.

The priority, therefore, is to carefully consider all the steps you will need to have in place to get started on CTIS, including the portals you need to register for, the people who need to be involved and any backup needed to manage the processes.

“Sponsors often overlook the time and the resources that need to be dedicated to the setup on CTIS and other portals.”