Learn more about Quality Assurance (QA)
Quality Assurance (QA) is defined in ICH-GCP as “all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded) and reported in compliance with Good Clinical Practice and the applicable regulatory requirements”.
Quality Control (QC) is defined as the” Operational technique and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.”
The QA team are responsible for providing oversight of the whole research process involving patient safety, data quality and research integrity. This includes reviewing and processing of SAE’s, SUSARS in particular those occurring in UHS sponsored studies, study/12 weeks exemptions, reviewing and authorising Standard Operating Procedures (SOPS), Maintaining and overseeing the Archiving process, providing Lab Reference Ranges to sponsors, assisting with monitoring visits and managing regulatory inspections including MHRA, HTA, HSE and conducting audits.
Examples of the types of audits we can conduct
- System audits – looking at the functionality of complete systems
- Process audits – looking at the performance of specific processes within the system
- Investigator site audits – trial-specific assessment of trial activities in the clinical setting
- Documentation audits – review of trial-specific or system documentation
We can also help with general queries regarding GCP, study set up and delivery alongside being able to answer governance/regulatory questions. We are an escalation point for any concerns or issues that research or clinical staff may have regarding research studies that are being conducted at UHS. Any incidents are logged onto the Trusts Electronic Reporting System that are linked to research are also flagged to the QA team,
Our team
- Dr Mikayala King – Research and Development Quality Assurance Manager
- Sharon Davies-Dear – Deputy Research and Development Quality Assurance Manager
- Luke Atwill – Research and Development Quality Assurance Officer
- Christy George – Research and Development Quality Assurance Officer
- Kim Lee – Senior QA Lead for the NIHR Southampton Clinical Research Facility (CRF)
- Joao Crespo – Quality Assurance and Administration Officer for the CRF
- Sue Wellstead – Clinical research Specialist in Education and QA
The QA team can be contacted at researchsafety@uhs.nhs.uk