Research Management in the Trust
Research management and governance in the Trust is currently overseen by the Joint Research Governance Committee.
The Joint Research Governance Committee is responsible for the governance of research activities within the Trust in line with the UK Policy Framework for Health and Social Care Research and provides advice on healthcare research to the University of East Anglia.
- The Committee has members from across the Trust and the University and meets quarterly. It currently reports to the Research Oversight Board.
Individual research studies taking place in the Trust must obtain Trust approval, local NHS confirmation of Capacity and Capability, a favourable opinion from an NHS Research Ethics Committee and Health Research Authority.
If you are seeking Trust approval for your research we advise that you contact the Research and Development office as early as possible in the process. When a new study comes into the office for approval, the relevant research facilitator will arrange to have a short meeting with you to undertake a risk assessment exercise for your study which allows any potential barriers to approval to be identified and dealt with as soon as possible.
Amendments to research must also be notified to the Research and Development office, in order to check that these do not affect the original terms of approval for the study. The research facilitators will review the amendments and issue confirmation of continuing Capacity and Capability.
Individual research studies may be subject to monitoring and audit from the Sponsor during the timeline of the study. Further information on the procedures for individual research studies to follow to ensure compliance with Good Clinical Practice are detailed in the Joint Trust and University of East Anglia Standard Operating Procedures.
Under the UK Framework for Health and Social Care Research all health and social care research projects require a sponsor. The sponsor is the individual, organisation or Partnership that takes on overall responsibility for proportionate, effective arrangements being in place to fund, set up, run and report a research project. The sponsor has overall responsibility for the research and is normally expected to be the employer of the chief investigator in the case of non-commercial research. Where you would like the Trust to be the Study Sponsor please refer to the following documents Sponsorship Policy document and Sponsorship SOP.
Good Clinical Practice
“Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.” EU Directive 2001/20/EC. Article 1, Clause 2
Good Clinical Practice is fundamental to safeguarding the well-being of participants in research studies and all researchers conducting a research study at the Trust will need to submit evidence that he/she has completed a recent GCP training course. Details of classroom based training .Online training is also available through the Local Clinical Research Network.