Managing Sponsorship

Research Services

University of Oxford

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)

University Clinical Research Portfolio

Applications

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

Challenges

Attitudes

• Resistance to change

• Resistance to regulations

• Resistance to regulators

Resistance of some balanced by the enthusiasm of others

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

Delegation of Responsibilities

*

Sponsor to Chief Investigator

Chief Investigator

Sponsor

Clinical Trial Planning

• Protocol development

• Arrangements* Funding* IMP * Contracts* Safety reporting* Data management

* Monitoring* Risk assessment* Insurance* SOPs* Training

Ongoing Oversight

• Safety Reporting• Monitoring• Audit: systems, trials• Review of annual reports• Amendments• Complaints, concerns, untoward events

Risk-adapted Approach to Monitoring

• Risk assessments• Develop as a tool for sponsor and trials units

– Central monitoring– Focussed monitoring

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

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

Safety Reporting Guidance

• Compliant SAE form

• Protocol template containing safety section

• Core SOP

• Development Safety Update Report template

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/)

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/gcpoxford/)

Website

Provides• Advice and information• Document templates• Core SOPs• Training information and registration

(www.admin.ox.ac.uk/researchsupport/ctrg/)

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

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

Challenges

Change and evolution of research environment

• GafREC Guidance• Reorganisation of NIHR Networks• HRA assessment• EU Clinical Trials Regulation

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