Skip to main content

Quality

Quality Management System 

The CRSU supports the delivery of research projects to the highest standards of research and clinical governance, ensuring  

  • the rights, safety and well-being of trial subjects are the overarching concern  
  • quality and safety considerations are embedded throughout the Unit  
  • promoting a culture of continual assessment and quality improvement.  

The CRSU has documented and maintained a quality management system in accordance with the requirements of ICH Good Clinical Practice (ICH-GCP) Guidelines and all applicable regulatory requirements. The QMS provides the tools needed to implement quality control, quality assurance and quality improvement for clinical research. 

Policies and Procedures

Institutional Policies

UL Equality and Diversity Policy 

UL Data Protection Policy

Clinical Research Policy For UL Sponsored Regulated Trials

University of Limerick Research Integrity Policy 

UL Records and Retention Policy

CRSU Processes

Access to Supports

Policy/Procedure for Criteria for Stopping Trials

Suspension or premature termination of clinical trials

Green Light Checklist

Study Costing Checklist Guide

CRSU application for support

HSE Data Protection Policy

HSE Diversity Equality and Inclusion https://www.hse.ie/eng/staff/resources/diversity/

International Policies

Declaration of Helsinki

Good Clinical Practice (GCP) as outlined in ICH Harmonised Tripartite Guidelines for GC