Menu

Regulatory Affairs

Contact: Dr. Ruben Keane

Director of Quality and Regulatory Affairs

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-C 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

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

Quality and Regulatory Affairs:

Our experienced regulatory staff can carry out preparation and submission of Clinical trial applications (Initial CTA and amendments) and Research Ethics Committee applications for IMP Trials, medical device investigations and other interventional or observational studies.   Our Director of Quality and Regulatory Affairs can provide advice on regulatory requirements of prospective studies and Interact with HPRA on behalf of Investigator/ Sponsor.

Clinical Research Ethics Committee of the Cork Teaching Hospitals – SUBMISSION AND MEETING DATES 2018 & 2019

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

ENQUIRE

Coronavirus (COVID-19)

In light of the Covid-19 situation, in advance of attending for a scheduled patient visit, please confirm the visit with your research nurse.