RDF19 Poster Detail
|The Value of a Quality Assurance Co-ordinator within an R&D Department|
2019 marks the 21st anniversary of the birth of the R&D Directorate at the Royal Wolverhampton Trust. Quality Assurance has been at the heart of the Directorate from the very beginning providing support and guidance to researchers from around the Trust and organisations across the research community. As well as overseeing the training and education requirements for researchers experienced and new.
Research is governed by a wealth of statutory and regulatory requirements which are often confusing for researchers but are essential to ensuring patient safety and high quality delivery of research. The quality assurance function at RWT uses a variety of mechanisms including audit, monitoring, patient experience, SOP management and training, review of serious incidents, co-ordinating root cause analysis and action planning, archiving, equipment, risk management.
Preparation for potential MHRA inspections, sponsor Internal Audits and queries in relation to NHS policies e.g., GDPR, Information Governance, Health Records Management, etc. Liaising with regulatory authorities and seeking advice from National Agencies e.g., MHRA.
The role provides benefits to sponsors as when monitors visit they can be assured that the quality of the data captured is audited by the Quality Assurance Co-ordinator
The Quality Assurance Co-ordinator is a source of independent advice to R&D Senior Management and Clinical Team.
Challenges or difficulties that may arise e.g., with other Trust support services are addressed by effective partnership working between the Quality Assurance Co-ordinator and Trust colleagues. Adherence to policies and procedures, regular review of departmental risks.
During a time of increased pressure on R&D budgets financial investment in this role is considered essential by both the R&D Clinical Director and R&D Directorate Manager at RWT. The role has on numerous occasions proved to be invaluable in providing research governance assurance to the Trust.
|The Royal Wolverhampton NHS Trust|