This site provides information and guidance of interest to researchers who lead or support clinical trials which are sponsored by the University. The University sponsors a wide range of clinical trials. The only type of clincal trial which the University will not sponsor are clinical trials of investigational medicinal products (IMP-trials).
Clinical trials are a special type of health care research project and, as such, the University's healthcare research governance process applies to clinical trials, as it does all types of health care research.
This web page explains the University's approach to how it assures the quality of clinical trials that it sponsors - it's a partnership with academic departments and the Chief/Principal Investigators of the clinical trials.
The University is responsible for the clinical trials which it sponsors and, therefore, needs to be confident that those trials have robust systems and practices in place for protecting participants who have been recruited and for ensuring the validity of data. Accordingly, the University seeks to quality assure (QA) University-sponsored trials.
The University's QA approach is guided by pragmatism and proportionality and by a spirit of cooperation with the researchers who lead and support the trials.
The University's definition of a clinical trial:
Clinical trials are research studies designed to answer specific questions about intervention(s) in human participants, whose purpose is to investigate the effectiveness of the intervention(s) & wherever possible to improve health outcomes. A clinical trial may be diagnostic, preventative or reactive in relation to a disease, may be invasive or non-invasive & may or may not involve a therapy.
What is the QA approach about?
The University needs to be confident that University-sponsored clinical trials have in place present and effective systems and practices for:
- a. Safeguarding the dignity, rights, safety & well-being of participants recruited; and for
- b. Ensuring the validity of the data collected, analysed, recorded & reported.
The University also wishes to identify good practices in how University-sponsored clinical trials are managed and for these practices to be shared between trials operating across the Faculty.
The QA approach involves an initial risk assessment of the clinical trial, followed by the implementation of a risk-appropriate procedure (conducted by an independed clinical trial assessment team). Further information on the approach is contained in the right-hand box 'The quality assurance (QA) approach'.
If you cannot find the information you need from this site and/or wish to speak to someone for further information then please contact Mrs Lindsay Unwin in the Quality and Governance team of Research and Innovation Services (email: email@example.com / ext. 21443).
Introduction to the quality assurance approach
- Types of clinical trial
- Clinical trials that the University will and will not sponsor
- The University's approach to University-sponsored clinical trials
The quality assurance (QA) approach
- Definition of QA in this context
- Flow diagram explanation of the QA approach
- Narrative explanation of the QA approach