Complying with the Clinical Trials Regulation: Guidance for sponsors
As part of the new Regulation, sponsors have new requirements to comply with. Sponsors should use the resources listed below to comply with the Regulation, which includes using CTIS.
Transition period ends 31 January 2025
There has been a transition period for clinical trial sponsors to fully comply with the new regulation. This transition period ends on 31 January 2025. This means that all clinical trials approved under the previous Directive must now be recorded in CTIS.
Support for implementing the CTR
Sponsors can consult the resources published by the HPRA, the HMA and the European Commission. For CTIS resources, see the CTIS section below.
HPRA guide to conducting clinical trials in Ireland
The HPRA has compiled regulatory requirements for sponsors into a guidance document. Sponsors should use this document to help them comply with requirements for topics including:
- safety reporting
- supervision
- archiving
- appeals
- good clinical practice (GCP) inspections
HMA resources
The HMA's Clinical Trials Coordination Group has published guidance documents and templates, such as cover letter templates for initial applications and substantial modifications. You can view and download these documents on the HMA CTCG resources page.
European Commission resources
Eudralex Volume 10 contains guidance documents for sponsors. A number of documents in Volume 10 were updated to bring them in line with the CTR. Additionally, new documents were published to cover new aspects introduced by the CTR. View the resources on the Eudralex Volume 10 page.
Extra support for non-commercial sponsors (ACT EU)
The ACT EU initiative aims to address problems that make it challenging for non-commercial sponsors, such as academic sponsors, to run clinical trials, especially across multiple countries. ACT EU will propose practical and harmonised solutions to help these sponsors conduct trials more easily throughout the EU.
For more information, visit the ACT EU website.
How to use CTIS
The EMA has created many training resources to help sponsors use CTIS. You can find the complete list on the EMA’s CTIS training and support webpage.
Sponsors should pay particular attention to the following training resources.
Sponsor handbook
The CTIS handbook is for both commercial and non-commercial sponsors. It covers priority topics identified by sponsors and includes links to further supporting materials.
CTIS online training modules
Sponsors can view the list of EMA online training modules to find:
- a full catalogue of available training modules, organised by clinical trial lifecycle stage
- the latest new or updated training materials
- technical system requirements for the best experience with using CTIS
Technical support
If you need technical assistance, you can contact the CTIS Service Desk to log a support ticket.