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 May 2018 to include information on Good Clinical Practice (GCP) Inspections, and other updates.  A track changes version of the guide is attached.
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 2019

Clinical Trial cut off and meeting dates 2018
Clinical Trial cut off and meeting dates 2017
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

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

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