Quality and Regulatory Affairs
Contact: Máire McCarthy
The HRB CRF-UCC Quality and Regulatory Department helps to ensure that academic funded patient focused research undertaken under the supervision of the HRB CRF-UCC 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 available 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-UCC Staff can assist you will these elements of the application process.
Please contact Máire McCarthy