Quality and Regulatory Affairs

The CRF operates under a robust quality system which has undergone two successful Health Product Regulatory Authority Inspections.

The Quality and Regulatory Affairs Manager (QRAM) ensures that research undertaken within the CRF is conducted to the highest regulatory standards and is delivered in accordance to ICH-GCP.

Our QRAM is available to assist investigators with their research by:

• Providing advice on development of research protocols, standard operating procedures etc
• Assisting with Research Ethics and Health Products Regulatory Authority (HPRA) submissions
• Providing ICH GCP and other regulatory training for study staff
• Conducting audits and monitoring of ongoing studies to ensure compliance with national and international legislation and guidelines.

The Quality and Regulatory Affairs Manager is available to provide advice throughout the set-up, conduct and reporting phases of your research project.