Clinical Trial Management & Governance

Trial/Project Management

 

  • Protocol writing
  • Costings for grant applications
  • HRA/ethics/IRAS submissions
  • Sponsor oversight
  • Risk assessments
  • Close collaboration with chief investigator, data manager, study statistician and trial co-ordination staff
  • Trial Management Group and Investigator meeting support
  • Multicentre site setup, monitoring and close out
  • Pharmacovigilance
  • Archiving
  • Working in accordance with CTU SOPs

 

Research Governance

 

The Research Governance Framework is made up of regulations, principles and standards of good practice designed to achieve and continuously improve research quality. It applies to everyone connected to clinical research, whether as a chief investigator, care professional, researcher, their employer(s) or support staff. Clinical research is any health-related research that involves humans, their tissue and/or data. More information can be found here:http://beta.hra.nhs.uk/planning-and-improving-research/policies-standard... 

Research governance is essential in order to:

  • safeguard participants in research
  • protect researchers/investigators (by providing a clear framework within which to work)
  • enhance ethical and scientific quality
  • mitigate risk
  • monitor practice and performance
  • promote good practice and ensure that lessons are learned

For all trials sponsored by the Univeristy of Surrey, we work in tandem with the Research Integrity and Governance Office (RIGO), which provides support to researchers in order to safeguard compliance, good practice and policies.

RIGO is the central point of contact for all external enquiries about research governance and ethics at the University of Surrey: 

https://www.surrey.ac.uk/research/our-approach/governance

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