-
Courses
Courses
Choosing a course is one of the most important decisions you'll ever make! View our courses and see what our students and lecturers have to say about the courses you are interested in at the links below.
-
University Life
University Life
Each year more than 4,000 choose University of Galway as their University of choice. Find out what life at University of Galway is all about here.
-
About University of Galway
About University of Galway
Since 1845, University of Galway has been sharing the highest quality teaching and research with Ireland and the world. Find out what makes our University so special – from our distinguished history to the latest news and campus developments.
-
Colleges & Schools
Colleges & Schools
University of Galway has earned international recognition as a research-led university with a commitment to top quality teaching across a range of key areas of expertise.
-
Research & Innovation
Research & Innovation
University of Galway’s vibrant research community take on some of the most pressing challenges of our times.
-
Business & Industry
Guiding Breakthrough Research at University of Galway
We explore and facilitate commercial opportunities for the research community at University of Galway, as well as facilitating industry partnership.
-
Alumni & Friends
Alumni & Friends
There are 128,000 University of Galway alumni worldwide. Stay connected to your alumni community! Join our social networks and update your details online.
-
Community Engagement
Community Engagement
At University of Galway, we believe that the best learning takes place when you apply what you learn in a real world context. That's why many of our courses include work placements or community projects.
Researcher Access
Important Documents For Researchers
The CRDO supports researchers and to help researchers navigate through the setting up and management of clinical research, resources and advice are available in this area of the website.
1. SOPS
GCP guidelines states there should be procedures in place to ensure that clinical trials are conducted, documented and data generated in compliance with the protocol, GCP and the applicable regulatory requirements.
SOP's will be uploaded to the website soon
2. Policies (e.g. Quality Policy)
Policies will be up uploaded to the website soon
3. Data Protection
Data Protection is the means by which the privacy rights of individuals are safeguarded in relation to the collecting and processing of their personal data. DPIAs are important tools for negating risk, and for demonstrating compliance with the GDPR
A Data Protection Impact Assessment (DPIA) describes a process designed to identify risks arising out of the processing of personal data and to minimise these risks as far and as early as possible.
A DPIA is required to be completed and approved by the applicable DPO/DDPO for each clinical study, prior to the study being approved or opened for recruitment. See links below for HSE and NUIG DPIA/PIA templates.
The HSE and NUIG approved DPIAs for clinical research data that adheres to the clinical research quality system are located here on Sharepoint. Please refer to the governing SOP on how to use these documents.
https://www.dataprotection.ie/
4. HPRA Approval
The Health Products Regulatory Authority (HPRA), is Ireland’s competent authority and the state body responsible for regulating medicines, medical devices and other health products.
The decision tree in Annex 1 can be used to identify whether a trial is an interventional/regulated clinical trial in the sense of the directive/regulations:
Please refer to Page 17 of this document
HPRA Publications & Forms are available here
5. EC/NREC Approval
All clinical trial/Investigations must also be pre-approved by an Ethics Committee. Please click here for submission deadline dates, meeting dates and contact details of the Galway Clinical Research Ethics Committee.
All interventional, regulated clinical trials and investigations must be pre-approved by the National Research Ethics Committee. Please click here for all details/forms and submission dates.