Complying with the Clinical Trials Regulation: Guidance for sponsors

This page provides resources to help sponsors comply with the Clinical Trials Regulation (CTR) and use the Clinical Trials Information System (CTIS). This includes both national and EU‑level guidance, as well as information about paying fees to the HPRA.

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 (CTCG) has published guidance documents and templates for sponsors, such as cover letter templates for initial applications and substantial modifications.  You can view and download these documents on the HMA CTCG resources page.  In particular, sponsors should be aware of CTCG guidance for applying the Article 11 workaround when intending to submit Part-I only initial applications in some member states.

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. 

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 Clinical Trials Information System (CTIS) is the shared EU portal for clinical trial applications. All clinical trials carried out in the EU/EEA must be submitted to CTIS.

The EMA has created many training resources to help sponsors use CTIS which can be found on the CTIS training and support webpage.

Sponsors should pay particular attention to the following resources:

• Guidance on CTIS account and user set-up for sponsors
• Links to further supporting materials and training videos

The Sponsor FAQ answers the most common questions raised by sponsors about using CTIS. It complements the sponsor handbook and is regularly updated as new issues arise.

CTIS live training

For issues not covered by the Sponsor handbook and FAQ please visit the EMA CTIS Support webpage.

The EMA regularly publishes lists of known CTIS issues and workarounds.

If you need technical assistance, you can contact the CTIS Service Desk to log a support ticket.

CTIS news and events

Clinical trial fees information

Visit the fees page to:

• Download the HPRA guide to fees to identify the correct fee code
• Download and complete the fee application form
• View details for making a bank transfer

There are no fees for non-commercial/academic trials.