1. Managing Sponsorship Research Services University of Oxford

2. Range of CTRG remit Sponsorship * Compliance oversight – initial and ongoing Advice and support * Templates and Standard Operating Procedures * Good Clinical Practice Training *Face to face *Online Insurance database for annual returns Oxford Tropical Medicines Research Ethics Committee (OXTREC)

3. University Clinical Research Portfolio

4. Applications

5. Challenges Diversity Size Knowledge & Resources Phase Risk level Classification Clinical trials vs experimental medicine Limited budget Within research funding e.g. database software, monitoring Within CTRG

6. Challenges Attitudes Resistance to change Resistance to regulations Resistance to regulators Resistance of some balanced by the enthusiasm of others

7. Approval of Sponsorship Quality check prior to submission Specific safety issues Peer review Funding Patient and Public Involvement Insurance - referral where appropriate Database - annual insurance returns

8. Delegation of Responsibilities * Sponsor to Chief Investigator Chief Investigator Sponsor

9. Clinical Trial Planning Protocol development Arrangements * Funding * IMP * Contracts * Safety reporting * Data management * Monitoring * Risk assessment * Insurance * SOPs * Training

10. Ongoing Oversight Safety Reporting Monitoring Audit: systems, trials Review of annual reports Amendments Complaints, concerns, untoward events

11. Risk-adapted Approach to Monitoring Risk assessments Develop as a tool for sponsor and trials units –Central monitoring –Focussed monitoring

12. Safety Reporting Delegated through risk assessment No safety monitoring committee –Trial Safety Group (University & OUH) Safety monitoring committee in place –Update CTRG with safety concerns –Development Safety Update Report

13. Trial Safety Group Parallel systems with Oxford University Hospitals NHS Trust SAEs reported to CTRG for review SAEs reviewed weekly by medical monitor (3 days for possible SUSARs) Reviewed quarterly by Trial Safety Group

14. Safety Reporting Guidance Compliant SAE form Protocol template containing safety section Core SOP Development Safety Update Report template

15. Training On-line Interactive GCP course –Developed by representatives of Trusts and Universities from across UK –Subject to periodic update (www.admin.ox.ac.uk/researchsupport/ctrg /gcponline/)

16. Training Face to face Full GCP Training Core module: CTIMPS Core module: Research studies Trial Design Preparation for Submissions All subject to ongoing development (www.admin.ox.ac.uk/researchsupport/ctrg/gcp oxford/)

17. Website Provides Advice and information Document templates Core SOPs Training information and registration (www.admin.ox.ac.uk/researchsupport/ctrg/)

18. Template Documents Protocol Templates * Clinical Trial * Clinical Research Study Independent Peer Review Template Example Case Report Form Log of Delegation of Responsibilities and Signatures Training Form Trial Master File Index Subject Identification and Code list Research Master File Index Serious Adverse Events Reporting Form Serious Adverse Events Reporting Form Completion Guidelines Safety Reporting Requirements in Clinical Trials Development Safety Update Report Template Final Report Template

19. Core Standard Operating Procedures Generation, Issue and Control of SOPs Protocol Development Safety Reporting for CTIMPs Training for Clinical Research Archiving of Essential Documents Trial Master File & Investigator Site File Preparation of Participant Information Sheets and Informed consent forms Serious Breach of Good Clinical Practice or the Trial Protocol Managing Complaints Arising from Clinical Research Urgent Safety Measures Under development Regulatory Approvals; Monitoring

20. Challenges Change and evolution of research environment GafREC Guidance Reorganisation of NIHR Networks HRA assessment EU Clinical Trials Regulation

21. Summary Sponsorship is not an insignificant responsibility, regardless of risk A risk adapted approach is essential Responsibility is ongoing and continuous Complaints are usually constructive Researchers are not natural criminals