1. Sarah Faghihi Research Compliance Decision Support Analyst Office of Research Administration Faith Pottschmidt, JD Director, Clinical Trials Contracting, CTSI

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

3.  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. 9 MonthAmendsCDA'sCTAsMisc In Progress Jul-10161847687 Aug-1019 34577 Sep-1092134670 Oct-10924411286 Nov-101521441090 Dec-101230331085 Jan-11153241492 Feb-11143533789 Mar-11163234587 Volumes of Documents at the CTC

10.  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. 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 60 0 0 49 5 6 37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts 0102030405060 Calendar Days Days from Negotiation Start to Study Activation 03/05/1005/04/10 Days from Negotiation Start to First Comments Provided to Sponsor Days from First Comments Provided to Sponsor to Negotiation Complete Days from Negotiation Complete to Institution Execution Days from Institution Execution to Full Execution Days from Full Execution to Study Activation Total Date Negotiations Started Date First Comments Provided to Sponsor Date Negotiations Completed Date of Institution Execution Date of Full Execution Date of Study Activation [----------Intake and Negotiation Phase----------][--------Signature and Activation Phase---------]

13. Study A: ORA IRB Timeline Detail Based on CTSA Milestones 01020304050 Date Application Received Date Pre- Review Change Requests Sent to PI Date PI Resubmits Pre-Review Changes Date of First Full IRB Review Date Post- Review Change Requests Sent to PI Date PI Resubmits Post-Review Changes Date of Final IRB Approval 30 8 8 4 9 1 0 58 Days: Median Turnaround Reported for Fiscal Year 2010 New Full Board Approvals Calendar Days Days from Application Received to Final IRB Approval Days from Application Received to Pre-Review Change Requests Sent to PI Days from Pre-Review Change Requests Sent to PI to PI Resubmits Pre-Review Changes Days from PI Resubmits Pre-Review Changes to First Full IRB Review Days from First Full IRB Review to Post-Review Change Requests Sent to PI Days from Post-Review Change Requests Sent to PI to PI Resubmits Post-Review Changes Days from PI Resubmits Post-Review Changes to Final IRB Approval LEGEND ORA PI 03/23/1004/22/10 Total [--------------------------Pre-Review Phase-------------------------][----------------Post-Review Phase-------------]

16. 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. 26 Days from Institution Execution to Full Execution Days from Negotiation Complete to Institution Execution Days from First Comments Provided to Negotiation Complete Days from Negotiation Start to First Comments Provided Days from Full Execution to Study Activation Total 37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts 0102030405060 Study B: ORA Contract Timeline Detail Based on CTSA Milestones 11 1 13 1 0 Calendar Days Days from Negotiation Start to Study Activation 04/06/1003/11/10 Date Negotiations Started Date First Comments Provided to Sponsor Date Negotiations Completed Date of Institution Execution Date of Full Execution Date of Study Activation [---------Intake and Negotiation Phase-----------][----------Signature and Activation Phase-------]

18. 01020304050 33 7 11 4 3 6 Total 2 58 Days: Median Turnaround Reported for Fiscal Year 2010 New Full Board Approvals Study B: ORA IRB Timeline Detail Based on CTSA Milestones Days from Application Received to Final IRB Approval Days from Application Received to Pre-Review Change Requests Sent to PI Days from Pre-Review Change Requests Sent to PI to PI Resubmits Pre-Review Changes Days from PI Resubmits Pre-Review Changes to First Full IRB Review Days from First Full IRB Review to Post-Review Change Requests Sent to PI Days from Post-Review Change Requests Sent to PI to PI Resubmits Post-Review Changes Days from PI Resubmits Post-Review Changes to Final IRB Approval Calendar Days 01/29/1003/03/10 Date Application Received Date Pre- Review Change Requests Sent to PI Date PI Resubmits Pre-Review Changes Date of First Full IRB Review Date Post- Review Change Requests Sent to PI Date PI Resubmits Post-Review Changes Date of Final IRB Approval [---------------------------Pre-Review Phase------------------------][---------------Post-Review Phase--------------] LEGEND ORA PI

21. 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. 0 21 12 8 22 03/16/10 37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts 0102030405060 Study C: ORA Contract Timeline Detail Based on CTSA Milestones Date from Negotiation Start to Date First Comments Provided to Sponsor Date First Comments Provided to Sponsor to Date Negotiation Complete Date Negotiation Complete to Date of Institution Execution Date of Institution Execution to Date of Full Execution Date of Full Execution to Date of Study Activation 05/18/10 Date from Negotiation Start to Date of Study Activation Calendar Days 63 Total Date Negotiations Started Date First Comments Provided to Sponsor Date Negotiations Completed Date of Institution Execution Date of Full Execution Date of Study Activation [---------Intake and Negotiation Phase-----------][---------Signature and Activation Phase--------]

23. 01020304050 56 6 16 11 10 1 Total 12 58 Days: Median Turnaround Reported for Fiscal Year 2010 New Full Board Approvals Study C: ORA IRB Timeline Detail Based on CTSA Milestones Days from Application Received to Final IRB Approval Days from Application Received to Pre-Review Change Requests Sent to PI Days from Pre-Review Change Requests Sent to PI to PI Resubmits Pre-Review Changes Days from PI Resubmits Pre-Review Changes to First Full IRB Review Days from First Full IRB Review to Post-Review Change Requests Sent to PI Days from Post-Review Change Requests Sent to PI to PI Resubmits Post-Review Changes Days from PI Resubmits Post-Review Changes to Final IRB Approval Calendar Days 03/02/1004/27/10 Date Application Received Date Pre- Review Change Requests Sent to PI Date PI Resubmits Pre-Review Changes Date of First Full IRB Review Date Post- Review Change Requests Sent to PI Date PI Resubmits Post-Review Changes Date of Final IRB Approval [--------------------------Pre-Review Phase-------------------------][---------------Post-Review Phase--------------] LEGEND ORA PI

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

28. 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