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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
5/4 - 5/25Time Lapse 2: 21 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:
7Potential of Full Value of Contract:
$117,078Date of First Consent:
5/18/2010Actual Consented Subjects as of Nov 2010:
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
37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts
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
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
CalendarDays
01/29/10 03/03/10
[---------------------------Pre-Review Phase------------------------] [---------------Post-Review Phase--------------]
LEGENDORA PI
1/29 - 3/3IRB Review: 33 Days
10/20 - 11/3CDA Review: 14 Days
3/11 - 4/6CTA Review: 26 Days
6/30/10Fiscal Year 2010 Ends
7/1/09Fiscal Year 2010 Begins
Study B: 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.
10/20 - 11/3ORA Review of CDA: 14 Days
11/3 - 1/29Time Lapse 1: 87 Days
4/6 - 5/18Time Lapse 2: 42 Days
5/18First Consented Subject
10/20 - 5/18Total Time Between CDA Submission to First Consented Subject: 210 Days
6/30/10Fiscal Year 2010 Ends
7/1/09Fiscal Year 2010 Begins
Study B: 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.
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:
20Potential of Full Value of Contract:
$78,285Date of First Consent:
5/27/2010Actual Consented Subjects as of Nov 2010:
6
0
21
12
8
22
03/16/10
37 Days: Median Turnaround Reported for Fiscal Year 2010 New Clinical Trial Contracts
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
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
CalendarDays
03/02/10 04/27/10
[--------------------------Pre-Review Phase-------------------------] [---------------Post-Review Phase--------------]
LEGENDORA PI
Study C: 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.
7/28 - 7/29CDA Review: 1 Day
7/1/09Fiscal Year 2010 Begins
3/16 - 5/18CTA Review: 63 Days
6/30/10Fiscal Year 2010 Ends
3/2 - 4/27IRB Review: 56 Days
Study C: 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.
7/28 - 7/29ORA Review of CDA: 1 Day
5/18 - 5/27Time Lapse 2: 9 Days
6/30/10Fiscal Year 2010 Ends
3/2 - 5/18ORA Approval of Protocol and Contract: 77 Days
7/29 - 3/2Time Lapse 1: 216 Days
7/28 - 5/27Total Time Between CDA Submission to First Consented Subject: 303 Days
5/27First Consented Subject
7/1/09Fiscal Year 2010 Begins
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 faxsafaghih@iupui.edu
Faith Pottschmidt(317) 278-4509 phone(317) 274-5444 faxfpottsch@iupui.edu
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