CTIMPs
Sponsorship of Clinical Trials of Investigational Medicinal Products (CTIMPs) is managed by the Joint University of Leeds/ Leeds Teaching Hospitals sponsor QA office, led by Louise Harris.
The Sponsor QA Office supports the University of Leeds (UoL) and Leeds Teaching Hospitals NHS Trust (LTHT) in fulfilling their responsibilities as research sponsors.
The team ensures that all sponsored health and social care research meets regulatory requirements, including Good Clinical Practice (GCP) and UK Clinical Trials legislation.
Key responsibilities include:
- Assess study risk and define appropriate sponsor oversight
- Review and advise on protocol development to ensure regulatory and sponsor requirements are met
- Monitor compliance with GCP, regulatory requirements, and approved protocols to ensure patient safety and data integrity
- Support audits, inspections, and regulatory compliance
- Provide practical advice, training, and guidance throughout the trial life cycle
- Act as a key contact point for sponsor-related queries across UoL and LTHT
- Acting as a liaison between UoL and LTHT on sponsor-related matters
The office plays a vital role in maintaining high standards of research quality, safety, and governance.
Further information including CTIMP policies, procedures and documents can be accessed via the following links:
Research Guidance & SOPs (UoL Staff)
Research Guidance & SOPs (LTHT Staff)
Contact us:
For CTIMP sponsorship enquires please contact our Clinical Trials Monitoring team on: [email protected]