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Quality Assurance

The Quality Assurance and Regulatory unit provides regulatory support and resources for research teams and independent oversight of trial-related activities.

Resources

Resources for researchers include access to HRB Clinical Research Facility Galway’s (CRFG) Standard Operating Procedures (SOPs) and the Quality Management System. These documents are designed to provide clear written instructions and guidance to help researchers run their trial, ensuring compliance with applicable regulations.

Audit

Research studies, including facilities, may be audited by the QA team, depending on the risk of the study. The QA and Reg. group is also responsible for auditing studies on behalf of the Sponsor or Principal Investigator, should the need arise. Audits are conducted in accordance with the trial protocol, written procedures, Good Clinical Practice (GCP) and applicable regulatory requirements.

Inspection

The QA team also provides the interface with regulatory agencies (Health Products Regulatory Authority (HPRA)) on behalf of the Sponsor for GCP inspections and for follow and query resolution etc.

Training

The QA team assist with and participate in GCP training, GCP refresher training and required QMS training for individuals involved in clinical trials.

Regulations

Good Clinical Practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides public assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trial are credible and accurate.

International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (E6 (R2) ICH GCP) describes the responsibilities and expectations of all participants in the conduct of clinical trials, including Investigators, Monitors, Sponsors and Independent Ethics Committees (IEC).

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

Clinical Trials of Investigational Medicinal Products (CTIMPs) are subject to the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended (SI 2004/1031).

Clinical Trials of Investigational Medicinal Products are legislated using Directive 2001/20/EC - Implemented nationally into SI 190 of 2004, May 2004. Amended SI 878 of 2004, December 2004

GCP Directive 2005/28/EC – is implemented nationally into SI 374 of 2006, July 2006

Medical Device clinical investigations are subject to the Medical Device Directive and EN540. Clinical Investigation of Medical Devices for human subjects in the CRFG are run adherent to ISO 14155:2011.

Additional legislation that may need to be considered includes, but is not limited to;