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Quality and Regulatory affairs

Contact: Dr. Ruben Keane

Director of Quality and Regulatory Affairs

The HRB CRF-C Quality and Regulatory Department helps to ensure that academic funded patient focused research undertaken under the supervision of the HRB CRF-C is conducted to the highest standards. The Quality and Regulatory Department currently consists of the Director of Quality and Regulatory Affairs, a Pharmacovigilance Officer, a Monitor and a Quality Executive Assistant.

Our staff are available to assist Investigators and study staff by:

Quality

  • Monitoring:  A dedicated, trained Monitor is available to carry out a full range of monitoring
    activities including site initiation, ongoing clinical activity monitoring, drug accountability and site close
    out for Health Products Regulatory Authority (HPRA) regulated and non-regulated trials.
  • GCP Training: ICH-Good Clinical Practice (GCP) training is provided for Investigators and study site
    personnel
  • Other Training: Other training services are avaialable to both the Principal Investigators and study site
    personnel as requested: e.g. Pharmacovigilance, Study Documentation etc.
  • Audits / Quality Reviews: Sponsors and Investigators can request quality reviews and audits of studies to
    ensure compliance with national and international legislation and guidelines.
  • Pre Study Audit: Review of study documentation (Investigator Site file) before site initiation.

Regulatory Affairs

  • Study Planning: Providing advice on prospective studies /trials to PI and study site personnel at study set
    up.
  • Regulatory Planning: Interacting with HPRA to seek advice on behalf of PI re prospective study/ trial.
  • HPRA Approval: Submitting Clinical Trial Applications to HPRA on behalf of PI.
  • Ethics Committee Approval: Submitting Application to Research Ethics Committees  (REC) on behalf of PI
    for Clinical Trials and studies.
  • Amendments: Submitting study/ trial amendments to HPRA and REC.

The HRB CRF-C Staff can assist you will these elements of the application process.
Please contact Ruben Keane

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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.