1. © Imperial College LondonPage 1 Controls Assurance and Institutional Risk Management Gary Roper Research Governance Manager

2. © Imperial College LondonPage 2 Overview Institutional Controls Assurance Gap Analysis Working Document Change Implementation Project specific risk assessment Summary

3. © Imperial College LondonPage 3 Controls Assurance Staging and gap analysis process Simple way to separate provision and needs Allows clear goal setting Provides documentation to support compliance Provides core assessment for change management.

4. © Imperial College LondonPage 4 Gap Analysis Working Document CT Toolkit template from ‘Managing a portfolio of trials 3’ document. Based on UCL system. Originally complemented NHS system – now superseded. Identified Compliance Measures

5. © Imperial College LondonPage 5 Gap Analysis Working Document Levels of Responsibility Designation of Responsibility Financial Probity Reviews and Approvals Written Agreements Honorary Contracts Compliance

6. © Imperial College LondonPage 6 Gap Analysis Working Document Event Reporting Sponsorship Fraud and Misconduct Records Management Training

7. © Imperial College LondonPage 7 Gap Analysis Working Document Best Practice Previous Actions Current Review Actions Required Comments A. Council level responsibility for research governance is clearly defined and there are clear lines of accountability throughout the University leading to Council. B. There is a designated person with responsibility for the management of all clinical research undertaken

8. © Imperial College LondonPage 8 Change Implementation

9. © Imperial College LondonPage 9 Project Specific Risk Assessment Incorporated as part of sponsorship assessment and approval system. Allows review of potential risk to the Institution. Is used as a marker for monitoring and audit provision. Useful as an additional stage of project review.

10. © Imperial College LondonPage 10 Project Specific Risk Assessment HazardImpactLikelihoodScore Potential for adverse publicity/controversy Approvals process not adhered to Facilities not able to met project needs Financial costings not fully met Inadequate arrangements with collaborators Lack of training/experience Potential for adverse reactions Project management not clearly defined IP and/or publication process not defined Provision for vulnerable subjects

11. © Imperial College LondonPage 11 Project Specific Risk Assessment Grading score 1 (minimal) to 5 (catastrophic). Impact x Likelihood = hazard score. Mean hazard score provided overall project risk between 1 and 25. The greater the number the greater the risk.

12. © Imperial College LondonPage 12 Summary Controls Assurance and project risk assessment are two extremes of the same compliance process. Analysis essential for service provision and development. Both exercises provide valuable data to complement monitoring and audit requirements.