Updated HPRA Guide to the Clinical Trials Regulation

The HPRA has published an updated guidance document for sponsors conducting clinical trials in Ireland. The guide has been updated to reflect the full implementation of the Clinical Trials Regulation (CTR), and to align with current European and national guidance and best practices. 

It outlines HPRA supports for sponsors, including regulatory advice to determine if a study falls within the scope of the CTR, and the option for pre-submission meetings for non-commercial sponsors. 

Other updates have been made in the following areas: 

• Requirements and timelines for submitting notifications and trial results 
• Procedures for partial application submissions (Part I only) under Article 11 of the CTR 
• Guidance for clinical trials involving medical devices 
• Requirements for manufacture, import, and labelling of IMPs and AxMPs 
• Risk-adapted approaches to safety recording and reporting 
• Procedures for GCP inspections 
• Guidance on clinical trials with decentralised elements
  

Download the guide: Guide to clinical trials conducted under the CTR in Ireland

See our clinical trials webpage for resources on complying with the CTR: Complying with the Clinical Trials Regulation | Guidance for sponsors