Getting R&D Approval
This guidance is structured around the various stages of a research project:
- Project Planning
- Gaining Approval
- Project Implementation/Data Collection
- Analysis of Results
- Dissemination of Findings
The Research Governance Framework specifies the duties and responsibilities of all individuals and organisations involved in research.
Standard Operating Procedures outlined in the Documents library are used to manage research in the Trust.
Is it research?
Research is often confused with service evaluation and audit. Generally Service Evaluation and Audit do not require Research Ethics approval. NRES has provide guidance on how to define research on their website: http://www.nres.npsa.nhs.uk/
SAE Reporting & Pharmacoviligance
Researchers conducting CTIMPs including device trials should contact the research Governance Manager for advice on how SAE Reporting is processed and managed through the Trust. The R&D Office SOP on SAE Reporting and Pharmacoviligance plus template SAE report forms, process flow chart and guidance can be found in the Document Library.