The Research Department is here to support researchers during study set up, Hampshire Hospitals Foundation Trust confirmation of capacity and capability and throughout the lifetime of the study.
Whether you are setting up your own study, or participating in an existing multi-centre trial, we welcome being contacted early on in your research plans to help with any queries or issues there may be.
Training - Good Clinical Practice (GCP)
"Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.”
The principles of GCP state that each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s) (2.8, E6 Guideline for Good Clinical Practice). It is a key requirement for anyone involved in the conduct of clinical that they complete Good Clinical Practice (GCP) training and as such it is mandatory for any member of staff involved in Clinical Research.
Attending GCP training
Members of staff who are new to Clinical Research need to complete the Introduction to GCP training course. Although there is no requirement to attend the face-to-face course it is recommended for those new to research to do so as they would benefit from the group discussions which take place in a face-to-face session. New members are also able to undertake the on-line training - Introduction to GCP training course.
An update is then required every 2 years for staff members still actively participating in research. This GCP Refresher course can either be via a half day face-to-face course in the Trust or via an online course.
The face to face courses occur in both Winchester and Basingstoke and are a good opportunity to network with colleagues involved in Research across the Trust to share knowledge and experience in Research within our organisation.
If you would like to access the GCP e-learning courses or book on to a face-to-face GCP course please log in to NIHR Learn.
If you would like information about NIHR Learn and details about how to access it, please visit the NIHR Learn help site.
The following link gives our own step-by-step instructions for registering on a GCP course: GCP Registering Instructions
Research Curriculum Vitae (CV)
As well as being GCP-trained, all members of a Research Team are required to produce a research CV. Again, this is required to be updated every 2 years.
Please click here for a Research CV template and guidance on how to complete it.
Study set up
The Health Research Authority Approval brings together the assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee (REC) so that there is only one application to submit. The HRA website is a valuable and useful resource when planning and preparing your study.
- Is your project research?
- Planning your research
- Research Ethics Committees overview
- Preparing study documentation
- For detailed guidance go to the Integrated Research Application System (IRAS)
- Transparency responsibilities
Every research project requires a Sponsor and their role is to take overall responsibility for the management of the study. This is normally a University, pharmaceutical company or an NHS Trust.
If you would like Hampshire Hospitals NHS Foundation Trust to review your study for Sponsorship please contact the Research Department (Research.Team@hhft.nhs.uk).
Gaining Hampshire Hospital Foundation Trust's Confirmation of Capacity and Capability to open a study
All research taking place in the NHS requires Trust approval before it can commence. The Research Department issues this approval following feasibility and review of the study documents.
For Documents Required for Research Department Submission click here.
The Research Department encourages commercial research within Hampshire Hospital Foundation Trust and is keen to develop and expand our commercial involvement across the specialties.
Please contact Research.Team@hhft.nhs.uk for more information.
HRA decision tool: Is this Research?
How the Trust uses Patients’ information Link to HHFT web page]