The Ecosystem of Drug discovery and development
Oxford has outstanding capabilities at all stages of drug discovery and development. The Oxford EMCRF makes an important contribution in the early clinical translational sector.
Oxford EMCRF is supported by the Oxford NIHR BRC, a collaboration between the UoO and OUH Trust.
How is Oxford EMCRF Managed
Oxford EMCRF has levels of management and responsibility to oversee the strategic objectives as well as the deliverability and conduct of the research. An organisational chart providing generic details is provided below to demonstrate the governance structure in the CRF.
Strategic Oversight Committee (SOC)
The Oxford EMCRF Strategic Oversight Committee (SOC) directs the facility to set and meet long-term objectives. It develops the priorities for the Operational Management team to consider in their study deliverability and conduct. The SOC is responsible for facilitating funding applications that will support the facility’s infrastructure.
Scientific and Deliverability Review Committee (SDRC)
The role of the SDRC is to provide oversight for the selection and performance management of studies conducted by Oxford EMCRF. It will also provide advice through its Chair on all aspects of Oxford EMCRF operation including scientific and clinical priorities. The SDRC will review new business applications, conduct a proportionate risk assessment, and establish if studies can be effectively implemented in the facility.
CRF Management Committee
The CRF management committee is primarily responsible for the implementation of the strategy for the facility and maintenance of the quality system.
CRF Operational Team
The Operational Team are responsible for the day-to-day oversight of the operational policies and for utilising feedback channels to the Management Committee. The Operational Team are also responsible for the conduct of study-related activities.
Oxford EMCRF supports the delivery of these research projects to the highest standards of research and clinical governance, ensuring that quality and safety considerations are embedded throughout the facility, and promoting a culture of continual quality improvement. The facility has a documented and maintained quality management system in accordance with the requirements of ICH GCP Guidelines and all applicable regulatory requirements. Oxford EMCRF also aims to work to the best practice principles outlined by the NIHR CRF Network workstream and current MHRA Guidance for CRF accreditation. It takes a risk adaptive approach to assuring participant safety.
The Operational Policy is available here.
Patient & Public Involvement & Engagement
Oxford EMCRF will “engage to involve” patients and members of the public to help improve the quality of the research undertaken in the facility.
Oxford EMCRF stakeholders are multi-faceted. We work with varied clinical specialities and our work is overseen by both the University of Oxford and Oxford University Hospitals NHS Foundation Trust through the NIHR Biomedical Research Centre (BRC). The BRC cross -speciality collaboration within Oxford EMCRF provides an opportunity to share ideas and resources and work together to develop a wide-reaching patient and public involvement and engagement (PPIE) strategy.
PPIE in Oxford EMCRF will be undertaken in both an oversight capacity (as a representative on the SOC) and in working with research teams presenting with an “involvement gap”.
Engagement and outreach work will be conducted in collaboration with the research user groups’ own activities as well as Oxford EMCRF specific ones. The aim of engagement is to improve involvement through the research process in the facility.
Oxford EMCRF aims to support clinical researchers from the Medical Sciences Division at the University of Oxford and clinical researchers from the OUH Trust to conduct their research. Both new and established investigators are encouraged to undertake their experimental studies in Oxford EMCRF. The facility will also provide an opportunity for cross-theme/speciality collaborations, and the Oxford EMCRF will aim to facilitate these.
We also welcome researchers collaborating with industry and from the University Spin Out companies.
Figure adopted from Oxford NIHR BRC website: https://oxfordbrc.nihr.ac.uk/about-us-intro/
Principal Investigator Responsibility
Principal Investigators (PIs) are responsible for:
- Patient safety, the overall conduct of the study and for members of their research team
- Ensuring members of their research team have appropriate contracts with the host institution (research, honorary, substantive or letter of access)
- Ensuring their research team members have appropriate training
- Providing appropriate medical cover for their participants
A Nursing Network
Oxford EMCRF provides a unique opportunity to bring Research Nurses together from across the OUH Trust, the CRN and the University.
The range of nurses will be able to work together to support studies as required.
A facility like this provides:
- Access to experienced and skilled research nurses, across specialities
- Networking opportunities for all nurses in general across the OUH Trust and the University
- Training and development for both nurses who work in research or those who are pursuing a research path
Please note: RNs working within PI teams will manage their studies in Oxford EMCRF.
Oxford EMCRF will provide additional support as required.
- Newly refurbished unit in the old John Warin Ward, Old Road Campus
- Easily accessible to participants and researchers
- Close proximity to CCVTM; Clinical Biomanufacturing facility; Churchill Hospital