Sarah Faghihi Research Compliance Decision Support Analyst Office of Research Administration

1. Tracking the Clinical Trial Process:From Confidentiality Agreement (CDA) to First Subject Enrollment Sarah Faghihi Research Compliance Decision Support Analyst Office of Research Administration Faith Pottschmidt, JD Director, Clinical Trials Contracting, CTSI

2. CTC Process Review and Redesign Identify Customer Needs • Timely Negotiations • Reduce Legal Risks • Ensure Compliance – Federal, State and local regulations; University policies Design for Efficiency, Accuracy and Reality • Shift priority of the workload • Clinical Need/Condition/Subject Population • Study phase and protocol procedures impact on contract terms • Type of contract submission (HUD or Work Order) • Align personnel skills to the specific tasks (negotiating contracts vs. account setup and maintenance) • Consider cradle to grave processes (amendments)

3. Tools used in New Process • Workflow Illustration for training purposes – both internal and external uses. • SharePoint for data capture, management of daily workload, logging activity, sharing information within office, and evaluating staff performance. • Work Files setup consistently for maintaining electronic versions. • Forms for Takeout that track the many checkbox functions are completed in the correct order.

9. Volumes of Documents at the CTC

10. Metric Project Example: CDA to Enrollment • Data capture made it possible for ORA to perform a snapshot analysis of industry sponsored clinical trials • Goal: illustrate the length of time between CDA submission and first consented subject • Data Source: SharePoint query for contracts activated during Fiscal Year 2010 (Jul 09 – Jun 10) that had corresponding CDA’s • Design: Chose 3 studies based on contractual relationship • Sponsor – Institution • Sponsor – Institution Under Master • Sponsor – CRO – Institution

11. STUDY A Phase 2 – CRO; no Work Order Maximum Subject Enrollment per Contract: 30 Potential of Full Value of Contract: $308,213 Date of First Consent: 5/25/2010 Actual Consented Subjects as of Nov 2010: 11

12. Study A: ORA Contract Timeline Detail Based on CTSA Milestones [----------Intake and Negotiation Phase----------] [--------Signature and Activation Phase---------] 37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts Calendar Days Total 03/05/10 05/04/10 60 Days from Negotiation Start to Study Activation 5 Days from Negotiation Start to First Comments Provided to Sponsor 49 Days from First Comments Provided to Sponsor to Negotiation Complete 0 • Days from Negotiation Complete to Institution Execution 0 • Days from Institution Execution to Full Execution 6 Days from Full Execution to Study Activation

13. Study A: ORA IRB Timeline Detail Based on CTSA Milestones [--------------------------Pre-Review Phase-------------------------] [----------------Post-Review Phase-------------] Calendar Days Total 03/23/10 04/22/10 30 58 Days: Median Turnaround Reported for Fiscal Year 2010 New Full Board Approvals Days from Application Received to Final IRB Approval 9 Days from Application Received to Pre-Review Change Requests Sent to PI 4 Days from Pre-Review Change Requests Sent to PI to PI Resubmits Pre-Review Changes 8 LEGEND ORA PI Days from PI Resubmits Pre-Review Changes to First Full IRB Review 8 Days from First Full IRB Review to Post-Review Change Requests Sent to PI 1 Days from Post-Review Change Requests Sent to PI to PI Resubmits Post-Review Changes • 0 Days from PI Resubmits Post-Review Changes to Final IRB Approval

16. STUDY B Phase 1 – Work Order; no CRO Maximum Subject Enrollment per Contract: 7 Potential of Full Value of Contract: $117,078 Date of First Consent: 5/18/2010 Actual Consented Subjects as of Nov 2010: 5

17. Study B: ORA Contract Timeline Detail Based on CTSA Milestones [---------Intake and Negotiation Phase-----------] [----------Signature and Activation Phase-------] 37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts Calendar Days Total 03/11/10 04/06/10 26 Days from Negotiation Start to Study Activation 1 Days from Negotiation Start to First Comments Provided 0 • Days from First Comments Provided to Negotiation Complete 13 Days from Negotiation Complete to Institution Execution 11 Days from Institution Execution to Full Execution 1 Days from Full Execution to Study Activation

18. Study B: ORA IRB Timeline Detail Based on CTSA Milestones [---------------------------Pre-Review Phase------------------------] [---------------Post-Review Phase--------------] Calendar Days 58 Days: Median Turnaround Reported for Fiscal Year 2010 New Full Board Approvals Total 01/29/10 03/03/10 33 Days from Application Received to Final IRB Approval 3 Days from Application Received to Pre-Review Change Requests Sent to PI 4 Days from Pre-Review Change Requests Sent to PI to PI Resubmits Pre-Review Changes LEGEND ORA PI 11 Days from PI Resubmits Pre-Review Changes to First Full IRB Review 7 Days from First Full IRB Review to Post-Review Change Requests Sent to PI 6 Days from Post-Review Change Requests Sent to PI to PI Resubmits Post-Review Changes 2 Days from PI Resubmits Post-Review Changes to Final IRB Approval

21. STUDY C Phase 1/2 – No Work Order or CRO Maximum Subject Enrollment per Contract: 20 Potential of Full Value of Contract: $78,285 Date of First Consent: 5/27/2010 Actual Consented Subjects as of Nov 2010: 6

22. Study C: ORA Contract Timeline Detail Based on CTSA Milestones [---------Intake and Negotiation Phase-----------] [---------Signature and Activation Phase--------] 37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts Calendar Days Total 03/16/10 05/18/10 63 Date from Negotiation Start to Date of Study Activation 8 Date from Negotiation Start to Date First Comments Provided to Sponsor 12 Date First Comments Provided to Sponsor to Date Negotiation Complete 21 Date Negotiation Complete to Date of Institution Execution 0 • Date of Institution Execution to Date of Full Execution 22 Date of Full Execution to Date of Study Activation

23. Study C: ORA IRB Timeline Detail Based on CTSA Milestones [--------------------------Pre-Review Phase-------------------------] [---------------Post-Review Phase--------------] Calendar Days Total 03/02/10 04/27/10 56 58 Days: Median Turnaround Reported for Fiscal Year 2010 New Full Board Approvals Days from Application Received to Final IRB Approval 10 Days from Application Received to Pre-Review Change Requests Sent to PI 11 Days from Pre-Review Change Requests Sent to PI to PI Resubmits Pre-Review Changes 16 LEGEND ORA PI Days from PI Resubmits Pre-Review Changes to First Full IRB Review 6 Days from First Full IRB Review to Post-Review Change Requests Sent to PI 1 Days from Post-Review Change Requests Sent to PI to PI Resubmits Post-Review Changes 12 Days from PI Resubmits Post-Review Changes to Final IRB Approval

26. Illustration of Secondary Findings – Concurrent, Consecutive and Overlapping Submissions Concurrent Consecutive Overlapping

27. Questions? Thank You

28. Contacts: Sarah Faghihi (317) 274-2123 phone (317) 274-0264 fax safaghih@iupui.edu Faith Pottschmidt (317) 278-4509 phone (317) 274-5444 fax fpottsch@iupui.edu