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 ensures that research undertaken within the CRF is conducted to the highest regulatory standards and is delivered in accordance to ICH-GCP and is available to assist investigators with their research by:
- Providing advice on development of research protocols and other essential documents
- Assisting with Research Ethics and Health Products Regulatory Authority (HPRA) submissions
- Providing ICH GCP and other regulatory training for study staff
- Conducting audits of ongoing studies to ensure compliance with national and international legislation and guidelines.
TOOLS EMPLOYED
Three procedural tools were developed and introduced:
- Protocol Amendment Checklist: Ensured end-to-end tracking of approvals, training, and document updates.
- Site Initiation Visit Investigator Site File Checklist: Standardised ISF review to confirm site readiness.
- Informed Consent Documentation Form: Captured consent version, type, and date given to ensure regulatory accuracy.
The Quality and Regulatory Affairs Manager is available to provide advice throughout the set-up, conduct and reporting phases of your research project.