The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the HRB CRF is conducted to the highest standards. The HRB CRF-UCC operates in accordance with a fully regulatory compliant Quality Management System and provides the full suite of Quality and Regulatory services required to support world class patient focused research. The Quality and Regulatory Department consists of:

• Director of Quality and Regulatory Affairs,
• Two study monitors,
• Senior Pharmacovigilance officer
• Quality officer.

Pharmacovigilance/ Drug Safety:

Our dedicated Pharmacovigilance staff can provide pharmacovigilance services for your Clinical Trial/ Clinical Investigation. Services include:

• Provision of a dedicated pharmacovigilance email, phone and fax number for reporting Serious Adverse Events (SAEs)
• Training of site staff in reporting SAEs to study Sponsor
• Receipt and processing of SAEs / Serious Adverse Reactions (SARs) using a validated safety database
• Review of SAEs, validation, quality checks, queries to site, narrative writing
• Submission of Suspected Unexpected Serious Adverse Reactions (SUSARs) via EudraVigilance database to HPRA and other competent authorities, within mandated timelines.
• Preparation of tables and listings for annual Development Safety Update Report (DSUR)

For further information about HRB CRF-UCC Pharmacovigilanceservice, please contact Dr. Ruben Keane, Director of Quality and Regulatory Affairs.