Clinical Trial Applications

Making an Application

You can find information on making an application in the Guide to Clinical Trial Applications.
 
The guide was revised in October 2019 to include updated information on end of trial declarations. A tracked changes version of the guide is also available to download.

The Clinical Trials Sub-committee meets regularly to review all applications. This committee is a subcommittee of the Advisory Committee for Human Medicines.  

Applications are approved by the Management Committee of the HPRA which meets every week.


Clinical trials meeting dates

A list of cut-off dates for the submission of clinical trial applications and Clinical Trial Sub-committee cut-off dates are available below. 
 
Clinical Trial cut off and meeting dates 2020
 (Please note that the dates in this document were updated in March 2020). 

View the terms of reference and rules of procedure of the Clinical Trials Sub-committee.
 

Clinical Trials with Academic Sponsors

The HPRA does not charge a fee for clinical trials conducted by academic sponsors where there is no financial support for the conduct of the trial. Any request for a fee waiver should be clearly stated in the cover letter. 

A protocol template is available for academic sponsors on request to clinicaltrials@hpra.ie.
 

Further Information

You can find information on the definitions relevant to clinical trials in Volume 10 of the Notice to Applicants.
 
You can find guidance on applications to ethics committees on the Department of Health website. Information on clinical trials using medicinal products containing genetically-modified organisms is available from the Environmental Protection Agency website.

Payment of Fees Instructions

Clinical Trials Seminar for Academic Sponsors and Investigators – Responses to Participants Queries

Rimcazole Clinical Trial at Shandon Clinic – IMB Report 03 October 2011