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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,

The QA team can be contacted at

Guideline on 12 week exemption
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