Sarah Faghihi Research Compliance Decision Support Analyst Office of Research Administration

Sarah FaghihiResearch Compliance Decision Support Analyst

Office of Research AdministrationFaith Pottschmidt, JD

Director, Clinical Trials Contracting, CTSI

Identify Customer Needso Timely Negotiationso Reduce Legal Riskso Ensure Compliance – Federal, State and local regulations;

University policiesDesign for Efficiency, Accuracy and Reality o Shift priority of the workload o Clinical Need/Condition/Subject Populationo Study phase and protocol procedures impact on contract termso 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)

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

Month Amends CDA's CTAs Misc In Progress

Jul-10 16 18 47 6 87Aug-10 19 19 34 5 77Sep-10 9 21 34 6 70Oct-10 9 24 41 12 86Nov-10 15 21 44 10 90Dec-10 12 30 33 10 85Jan-11 15 32 41 4 92Feb-11 14 35 33 7 89Mar-11 16 32 34 5 87

Volumes of Documents at the CTC

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

Phase 2 – CRO; no Work OrderMaximum Subject Enrollment per Contract:

30Potential of Full Value of Contract:

$308,213Date of First Consent:

5/25/2010Actual Consented Subjects as of Nov 2010:

11

60

0

0

49

5

6

37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts

0 10 20 30 40 50 60

•

•

Calendar Days

Days from Negotiation Start to Study Activation03/05/10 05/04/10

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

[----------Intake and Negotiation Phase----------] [--------Signature and Activation Phase---------]

0 10 20 30 40 50

30

8

8

4

9

1

• 0

58 Days: Median Turnaround Reported for Fiscal Year 2010 New Full Board Approvals

CalendarDays

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

LEGENDORA PI

03/23/10 04/22/10Total

[--------------------------Pre-Review Phase-------------------------] [----------------Post-Review Phase-------------]

7/1/09Fiscal Year 2010 Begins

9/9 - 9/17CDA Review: 8 Days

3/5 - 5/4CTA Review: 60 Days

3/23 - 4/22IRB Review: 30 Days

6/30/10Fiscal Year 2010 Ends

Study A: ORA Turnaround Timeline

The timeline below depicts time spent in ORA across the fiscal year, which runs from July 1 to June 30. CDA Review is the time between CDA submission to fully signed, legally binding CDA. CTA Review is the time between CTA submission (contract, protocol, study budget) and study activation (signed contract, IRB approval, COI clearance and account number set up.) IRB Review is the time between submission of the IRB New study Application (Document Review and Approval form, Summary Safeguard, Informed Consent templates, Wavier for Emergency Research form, protocol template, Investigative new Drug/Device form, Recruitment Checklist and HIPPA Authorization templates) and approval of study by a convened IRB board. Durations are based on calendar days.

9/9 - 9/17ORA Review of CDA: 8 Days

3/5 - 5/4ORA Approval of Protocol and Contract: 60 Days

9/17 - 3/5Time Lapse 1: 169 Days


5/25First Consented Subject

9/9 - 5/25Total Time Between CDA Submission to First Consented Subject: 258 Days 6/30/10

Fiscal Year 2010 Ends7/1/09

Fiscal Year 2010 Begins

Study A: ORA Turnaround Timeline with Lapses

This timeline depicts the overall time that it took from CDA submission to first consented subject across the fiscal year. The time lapses on this timeline represent time that the ORA office had no documents to review or negotiate. Time Lapse 1 is the time between CDA completion and submission of either the protocol or contract (whichever occurred first) and Time Lapse 2 is the time between study activation (available upon signed contract, IRB approval, COI clearance and account number set up) and first obtained subject consent for study participation. Durations are based on calendar days.

Phase 1 – Work Order; no CROMaximum Subject Enrollment per Contract:




5

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


0 10 20 30 40 50 60

•

Study B: ORA Contract Timeline Detail Based on CTSA Milestones

11

1

13

1

0

CalendarDays

Days from Negotiation Start to Study Activation04/06/1003/11/10

[---------Intake and Negotiation Phase-----------] [----------Signature and Activation Phase-------]

0 10 20 30 40 50

33

7

11

4

3

6

Total

2


Study B: ORA IRB Timeline Detail Based on CTSA Milestones








CalendarDays

01/29/10 03/03/10

[---------------------------Pre-Review Phase------------------------] [---------------Post-Review Phase--------------]

LEGENDORA PI


10/20 - 11/3CDA Review: 14 Days




Study B: ORA Turnaround Timeline


10/20 - 11/3ORA Review of CDA: 14 Days




10/20 - 5/18Total Time Between CDA Submission to First Consented Subject: 210 Days



Study B: ORA Turnaround Timeline with Lapses


3/3 - 3/11

1/29 - 3/3ORA Approval of Protocol: 33 Days

Lapse from IRB Submission to Contract Submission: 8 Days

3/11 - 4/6ORA Approval of Contract: 26 Days

Phase 1/2 – No Work Order or CROMaximum Subject Enrollment per Contract:




6

0

21

12

8

22

03/16/10


0 10 20 30 40 50 60

•

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

05/18/10Date from Negotiation Start to Date of Study Activation

CalendarDays

63Total

[---------Intake and Negotiation Phase-----------] [---------Signature and Activation Phase--------]

0 10 20 30 40 50

56

6

16

11

10

1

Total

12


Study C: ORA IRB Timeline Detail Based on CTSA Milestones








CalendarDays

03/02/10 04/27/10

[--------------------------Pre-Review Phase-------------------------] [---------------Post-Review Phase--------------]

LEGENDORA PI

Study C: ORA Turnaround Timeline


7/28 - 7/29CDA Review: 1 Day





Study C: ORA Turnaround Timeline with Lapses


7/28 - 7/29ORA Review of CDA: 1 Day



3/2 - 5/18ORA Approval of Protocol and Contract: 77 Days


7/28 - 5/27Total Time Between CDA Submission to First Consented Subject: 303 Days



09/9/9 - 09/9/17CDA Review: 8 Days

10/3/5 - 10/5/4CTA Review: 60 Days

10/3/23 - 10/4/22IRB Review: 30 Days

10/20/09 - 11/3/09CDA Review: 14 Days

3/11/10 - 4/6/10CTA Review: 26 Days

1/29/10 - 3/3/10IRB Review: 33 Days

7/28/09 - 7/29/09CDA Review: 1 Day

3/16/10 - 5/18/10CTA Review: 63 Days

3/2/10 - 4/27/10IRB Review: 56 Days

STUDY A

STUDY B

STUDY C

Concurrent

Consecutive

Overlapping

Sarah Faghihi(317) 274-2123 phone(317) 274-0264 [email protected]

Faith Pottschmidt(317) 278-4509 phone(317) 274-5444 [email protected]

Sarah Faghihi Research Compliance Decision Support Analyst Office of Research Administration

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