Sponsorship and management

Research Sponsor

Under the UK Policy Framework for Health and Social Care Research, all health and social care research projects require a sponsor. This is the 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 Sponsorship Policy and SOP 400 Joint Arrangements for Research Authorisation of Research Sponsorship. Please contact R&D if you would like to apply for sponsorship.

Research management and governance

Our research management and governance are overseen by the Joint Research Governance Committee. This committee provides oversight of studies sponsored by the Trust or University of East Anglia (UEA) in line with the UK Policy Framework for Health and Social Care Research. The committee has members from across the Trust, the University and the Quadram Institute Bioscience and meets quarterly. It reports to the Research Oversight Board.

How to obtain approval for research

We advise you to contact the Research and Development (R&D) office as early as possible. A member of the R&D team will arrange 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

Amendments to research must be notified to the Research & Development office, to check that they do not affect the original terms of approval for the study. A member of the R&D team will review the amendments and issue a confirmation of continuing Capacity and Capability.

Monitoring and Audit

Individual research studies may be subject to monitoring and audit from the sponsor during the life 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 UEA Standard Operating Procedures.

Ongoing Reporting

Depending on the approval received, you may be asked to complete progress reports.  More information about progress reports is available on the Health Research Authority website.

Whether you are running a study being sponsored or hosted by NNUH, all safety reports should be notified/copied to the R&D office at rdsae@nnuh.nhs.uk. You can find more information regarding safety reporting on the HRA website.

At the end of study please notify the R&D office so that the reporting requirements can be completed. Once these are concluded, SOP 900 describes the process to be followed to ensure that essential study documents, working files, electronic data and records pertaining to the conduct of clinical research at NNUH and UEA are archived at the end of a study in accordance with ICH GCP.

Good Clinical Practice

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.

 Please refer to SOP 002 Good Clinical Practice (GCP) Training