Health Products Regulatory Authority (HPRA) updated the guidance document for clinical trials conducted in Ireland on February 03, 2022. This includes the guidelines specified in the new EU Clinical Trial Regulation (Regulation No 536/2014), adopted on 16 April 2014, and became applicable on 31 January 2022.
Key guidelines include :
- Sponsors conducting clinical trials in Ireland under CTR should submit an application in CTIS
- Sponsors should submit the results of the clinical trials within one year from the end of the trial via CTIS
- Along with clinical trial results, a summary written for lay persons should be submitted
Detailed guidance can be accessed here