The Role of the Research Office Joint Research & Enterprise Office (JREO) St George’s University of London and St George’s University Hospitals NHS Foundation Trust MaryCate MacLennan R&D Performance & Delivery Manager

What does a Research Office do? FINANCES & LEGAL Identification of research funding opportunities Costings and pre-award support for grant applications Financial management and administration of research grants and contracts Costing of (commercial) clinical studies Commercial/IP implications Contracts Distribution of funds to all departments involved in the protocol ETHICS/GOVERNANCE & COMPLIANCE Providing guidance on the Ethics process Sponsorship of clinical research studies Host site approval for clinical research studies Clinical and Research Governance on site (including study initiation, audit and monitoring, safety reporting, and study close-out) Co-ordinating external audits and regulatory inspections STRATEGY Partially responsible for delivering the Research Strategies Monitoring and reporting on research activity Training and guidance for researchers Supporting teams to think about future resourcing, plans, ambitions Connecting researchers/support departments Joint Research & Enterprise Office Training

What are the regulations* Research Governance Framework (2005) Data Protection Act (1998) Human Tissue Act (2004) NHS Code Of Confidentiality Mental Capacity Act (2008) Medicines for Human Use (Clinical Trials ) Regulations 2004 *list not exhaustive Joint Research & Enterprise Office Training

SGUL CouncilTrust Board Strategy, Planning & Resources Finance Senate Executive Management group Quality & Risk Finance & Performance Commercial Patient Safety Joint Executive Group Research Strategy Committee Joint Clinical Research Committee Joint Research Governance Committee Strategy Delivery / ManagementRisk, Compliance, Assurance Research Facilities JREO Troika Risk Management Audit

Structure Joint Research & Enterprise Office Training

Who do we deal with? JREO Support Departments Ethics Committees Investigators Regulators e.g. MHRA, FDA Funders Research Team Members SponsorsNHS Trusts Higher Education Organisations StudentsCROs Members of the Public inc patients Other departments eg Audit Office Joint Research & Enterprise Office Training

How we interact internally within our JREO Finance Ask for Costings Inform when studies are open Inform when studies are closed Enterprise Send & sign CDAs Review Intellectual Property implications Pre Award Ask for certain costs to be included Advise as to whether ethics is needed Post Award Inform when studies are open Inform when studies are closed

Joint Research & Enterprise Office Training How we interact internally within our JREO Legal Review of non-model contracts Ask for MTAs to be completed Any other legal advice needed (NIHR) Performance Manager Ask for feasibility Inform of problems Keep data up to date

Joint Research & Enterprise Office Training What we have done in the last 2 years – key areas. Audits – 31 studies audited 2013 and % of all studies active at St Georges. (10% is the target) Had 2 MHRA inspections, 1 FDA inspection Trained 277 people on Good Clinical Practice. Trained about 161 people on our training courses Updated existing 19 SOPs and added a further 28. And created 19 WPD. Archived 154 studies* (364 boxes in total) Increased no of Clinical trials recruiting their 1 st patient within 70 days from 50% (31 st Dec 2013) to 80% (31 st Dec 2014) Increased recruitment on CRN recruitment Largest (in terms of recruitment – not studies) of commercial portfolio in South London Investment in research time for clinicians. Bring new clinical areas into research