Meet the Quality Assurance (QA) team
What is Quality Assurance (QA)?
The UHS QA Team are responsible for providing oversight of the whole research process. This involves patient safety, data quality and research integrity.
Quality Assurance can be split into Quality Assurance (QA) and Quality Control (QC). These are defined by Good Clinical Practice (GCP) as:
- QA: All planned and systematic actions established to ensure the trial is performed, and the data are generated, documented (recorded) and reported in compliance with GCP and the applicable regulatory requirements.
- QC: Operational technique, and activities undertaken within the QA system to verify that the requirements for quality of the trial-related activities have been fulfilled.
How does your team support research in our university-hospital partnership?
Our team supports research, to ensure participants are safe and their data is kept securely. We do this via System, Process, Investigator and Documentation audits.
We can help with general queries regarding GCP, study set up and delivery, and answer governance or regulatory questions.
We review Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs). We manage monitoring visits and regulatory inspections.
We consider 12 Week exemptions and review Standard Operating Procedures (SOPs). We oversee the archiving process and provide Lab Reference Ranges to sponsors.
We are an escalation point for concerns or issues staff have regarding UHS studies.
Who is in the QA team?
We, as a team, cover the whole infrastructure of research:
- Dr Mikayala King – Research and Development Governance, Quality Assurance and Sponsorship Manager
- Sharon Davies-Dear – Deputy Research and Development Quality Assurance Manager
- Luke Atwill & Gemma Clarke – Quality Assurance Officers
- Hope Howard – Senior QA lead for ATIMPS
- Kim Lee – Senior QA Lead NIHR Wellcome Trust Clinical Research Facility
- Lucy Tarr – CRF Quality Assurance Officer
- Susan Wellstead - Clinical Research Specialist in Education and QA
How can staff get in touch?
You can email us at Researchsafety@uhs.nhs.uk.