Contact information for clinical trial queries
Assessment of applications:
Scientific assessment of applications:
clinicaltrials@hpra.ie / ctreg@hpra.ie
Ethical assessment of applications:
Pre-submission advice or scientific advice:
National advice:
clinicaltrials@hpra.ie / ctreg@hpra.ie
Advice is available free of charge for non-commercial/academic sponsors. Please contact us in advance of submitting a clinical trial to CTIS.
To request scientific advice from multiple competent authorities at the same time, apply through the
Simultaneous National Scientific Advice Pilot (SNSA).
For scientific advice on early-stage development of innovative medicines for clinical trials (Phase I/II) from more than one national competent authority at the same time.
SNSA queries:
SNSA@pei.de or innovationoffice@hpra.ie
Coordinated Pre-CTA advice is also available via the CTCG Pre-CTA advice pilot for regulatory and technical aspects of clinical trials:
Guidance for applicants Pre-CTA advice pilot_finalOpens in new window
Non-commercial/academic sponsors – request for HPRA protocol template:
Compliance and GCP (Good Clinical Practice):
Medical devices to be used in clinical trials:
Clinical trials using medicinal products containing genetically-modified organisms
Environmental Protection Agency webpage: