Quality Assurance

Quality Assurance

The ACCORD Quality Assurance (QA) group provides regulatory support and resources for research teams and independent oversight of trial-related activities.

Resources

Resources for researchers include access to ACCORD Standard Operating Procedures (SOPs) and policies. 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 a study specific risk assessment conducted by the Sponsor. The ACCORD QA group is also responsible for auditing hosted studies on behalf of Lothian Health Board, 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 on behalf of the Sponsor for GCP inspections and for notification and management of Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Breach reporting.

Training

The QA team can help provide GCP training, GCP refresher training and SOP 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).

Research Governance Framework for Health and Community Care (Scotland 2006 2nd edition) concerns setting standards to improve research quality and safeguard the public.  The framework details the responsibilities of key people involved in research and outlines the process for achieving governance.

Medical Device clinical investigations are subject to the Medical Device Regulations 2002, as amended (SI 2002/618).

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

● Data Protection Act 1998
● Adults with Incapacity (Scotland) Act 2000
● Human Tissue (Scotland) Act 2006