Trials that were authorised under the Clinical Trials Directive 2001/20/EC through EudraCT and are to be transitioned to CTIS are called Transitional trials.

Clinical trials authorised under the CT Directive regime can remain in EudraCT and continue to run under the requirements of the CT Directive until the end of the 3-year transition period (i.e. 30 January 2025), unless a new EU/EEA member state is added to the trial (this is considered a new trial application for this member state, and needs to be done through CTIS).

1 February 2025 – all ongoing CTs (Transitional) need to be re- submitted via CTIS for CT Regulations. EudraCT continues to operate for reporting CT Directives and global end of trials. Global end of the trial and trial summary results should be uploaded via EudraCT.

Sponsors must transition a trial from EudraCT to CTIS if at least one of the following conditions is fulfilled:

• the trial authorised under the CT directive is going to be submitted to an additional EU/EEA member state(s).

• the EudraCT trial completion date is expected to be after 30 January 2025.

In addition, only trials that meet the following criteria can be transitioned:

• Interventional clinical trials in humans.

• Involve at least one site in the EU/EEA where the trial is still ongoing.

• Not on hold , and no notification has been submitted regarding whether the trial has ended in the EU/EEA

In order to transition a trial from EudraCT to CTIS, an Initial CTA checkbox needs to be marked as a ‘Transitional trial’ and then click on the ‘Create’ button to generate draft Transitional trial before submition. If this checkbox is selected, users will be able to provide specific information about the trial being transitioned from EudraCT. In this way, users will be able to populate the structured data and documents in the CTA entirely in CTIS. There is no automated data population between EudraCT and CTIS.

Once the draft Transitional trial application has been created, users can start filling the required fields of the sections ‘Form’, ‘MSCs’, ‘Part I’ and ‘Part II’.  In order to populate a field, users can click on the ‘Padlock’ button in each sub-section and fill in the details.

Users can populate the rest of the CTA sections and check that all information has been filled correctly by clicking on the ‘Check’ button. The system will highlight the sections where mandatory data or documents are missing. The draft Transitional trial cannot be submitted if any mandatory fields or documents are not filled in or uploaded.

If the initial application has not yet been submitted and is still in draft form, sponsors can edit the transition trial section and select the “transition trial” checkbox, even if it was not selected during the creation of the new CT.

EMA has launched Organisation Management Service (OMS) to support regulatory activities throughout EU. OMS manages one of the four domains: substance, product, organisation, and referential (SPOR). If users do not find an organization after searching in OMS or CTIS, they may proceed to register it before submitting the transition application. Although previous registration of organizations in OMS is not mandatory, it is highly recommended, as organizations created locally in CTIS are not validated by the EMA.

To create a new organization in CTIS, users can click the ‘New Organisation’ button. This functionality is available only for registering the following organizations:

• Part I Sponsor section – Third-party organizations

• Part II – Trial sites

• Serious Breach notifications – Details of the site where the serious breach occurred

• Third Country Inspectorate Inspection – Third country inspection site

• MS Inspections – Inspected site

Organizations registered through OMS adhere to a data quality standard, reducing the likelihood of receiving RFIs from assessing authorities regarding inaccurate data.

IMP registration on XEVMPD (Extended Eudra Vigilance Medical Product Dictionary) is mandatory. If not registered, the sponsor will not be able to populate IMP information in the CTA.

MSCs may choose to authorise the trials within or in less than 60 days. However, MSCs can create RFIs on the transitional application (leading to a maximum period of 106 days, or further in the case of some types of investigational medicinal products). Therefore, sponsors are advised to submit their Transitional trials to CTIS early enough before the end of the transition period.

Sponsor users can submit trial and Recruitment periods notifications through the ‘Notifications’ tab on a clinical trial page once the Transitional trial has been authorised by the MSCs.

CTIS allows the sponsor users to submit the trial results after the authorisation of the Transitional trial in the ‘Trial results’ tab of a clinical trial page. The sponsor can submit the summary of results and the layperson summary within one year from the end of a CT (in all EEA MSCs or globally, if applicable), and within 6 months in case of paediatric trials or if the CT is part of a paediatric investigation plan.

MS users need to update in EudraCT the latest status of a transitioned trial to CTIS, which is only possible once the Transitional trial is authorised in CTIS. Each MSC is expected to perform this update on the EudraCT platform:

• Access the EudraCT platform and click on the ‘EudraCT Tools & Login’ section and login with their EMA credentials.

• Users click on the ‘Find’ tab and search for a trial by using its EudraCT number in the search bar. Once the results are displayed, they click on the ‘IoC’ button on the right-hand side.

•Once users click on ‘Ioc’, they can choose the status of the trial. For Transitional trials uploaded and authorised through CTIS, they need to select ‘Trial now transitioned’.

Once CT is marked as ‘Trial now transitioned’ in EudraCT by the MS, it is expected that sponsors will follow up on the trial on CTIS, including the submission of results. For this reason, it is essential that the relevant MS report the correct status of transitioned trials on the EudraCT database.

Author: Galina Fujimori Petrikova