CTSA Workshop Meeting June 21, 2010

1. CTSA WorkshopMeetingJune 21, 2010

2. CRM Contracts Group Mission • Study contract management processes across the CTSA Consortium • Provide metrics to document how CTSA members are doing • Recommend process improvements and best practices

3. The Contracts Group developed: • A list of agreed-upon terms to be utilized across the CTSA Consortium to enable an accurate metrics comparison in contracts management • Studies to obtain metrics on contract management timelines and review variables which impact those timelines

4. Pilot Contracts Study: • Consortium-wide collection of contract negotiation time frames including dates that: • Contract was received by negotiating office • First comments were sent to sponsor • Negotiation was finalized • Institution signed the contract • Contract was fully executed

5. Also collected contract characteristics: • Use of master agreement • Previously negotiated terms • CRO negotiated contract • Phase of study • Lessons learned were incorporated in the design of the Contracts Study currently underway

6. Pilot Study proved Consortium-wide data collection and harmonization of terms is possible and provided a large sampling of contract management data Status: data collection and analysis complete

7. Pilot Study Data Analysis All completed contracts 30 CTSA sites participated - 500 Completed Contracts 68.6 - Mean days to completion for all contracts 0 - Minimum day to completion 278 - Maximum days to completion Site Performance 25.5 - Shortest mean days to completion at a site 106.2 - Longest mean days to completion at a site 2 - Least number of contracts at a site 28 - Most number of contracts at a site 17 - Mean number of contracts at the sites

8. Pilot Study Data Analysis, cont. Major Lesson Learned – When sites have parallel processes for IRB, budget and contract, execution of the contract is held until the other processes are complete, so the measurement of the date the contract arrives at the negotiation office to the date of finalization of negotiations provides a better view into the performance of the contract negotiation process 38.2 - Mean days to negotiation finalization for all contracts

9. Pilot Study Data Analysis, cont. 130 - Contracts using master agreements 54.2 - Mean days to completion (14.4 days less than all contracts) 19.9 days less than contracts with no master agreement (n=360) 131 - Contracts negotiated by CROs 77.8 - Mean days to completion (9.2 days more than all contracts) 13.3 days more than contracts with no CRO negotiated by CROs (n=365) 407 - Contracts for multicenter studies 71.2 - Mean days to completion (2.6 days more than all contracts) 14.6 days more than contracts for single-site studies (n=74)

10. Current Contracts Study • Same data points as collected as in Pilot Study plus addition of date that: • PI received protocol • Protocol submitted to IRB • IRB approved protocol Additional contract characteristic: • Cancer treatment study

11. Collection of process maps to illustrate contracting, IRB and budgeting processes at each site, in order to relate metrics to processes Also inquired into resource deployment (how many personnel perform which functions)

12. Status of Current Contracts Study: • Data collection on-going • Projected completion of data collection: Q4 2010 • Projected article submission: Q1 2011

13. Thank you Adam P. Rifkind, Esq. Associate Director, Corporate Contracts Office of Research Services University of Pennsylvania Libby D. Salberg, J.D. Director, Office of Grants & Contracts Management Vanderbilt University Medical Center