Clinical trials and research studies must follow strict regulations and guidelines. Medical research must adhere to ethical standards that respect the rights, safety and well-being of participants. All studies must have Research Ethics Committee approval before commencing. Clinical Trials involving a medicinal product must also receive Regulatory approval from the Health Products Regulatory Authority prior to commencing. In addition, all research performed within the Clinical Research Facility is reviewed and approved by the CRF Operational Management. The CRF Scientific Advisory Committee may also review a study if required. A full time Quality and Regulatory Affairs Manager is employed within the CRF. They ensure study activities are consistent with those outlined in the study protocol and in compliance with current legislation and guidelines, and that participants’ rights, safety and well-being are maintained while taking part in the study.