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CTR Resources & Services. Wendy M Kohrt, PhD Associate Director, CTR R&S. Outline. New Governance Model. Funding. Scientific Protocol Review. Program Income System and Tracking. MicroGrants Program. Governance. R&S Management Committee. CTR Resources & Services Kohrt.
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CTR Resources & Services Wendy M Kohrt, PhD Associate Director, CTR R&S
Outline • New Governance Model • Funding • Scientific Protocol Review • Program Income System and Tracking • MicroGrants Program
Governance R&S Management Committee CTR Resources & Services Kohrt Study Implementation Population-based Translational Research Programs Study Design and Analysis Lab Analysis and Technology CTRC Network Eckel Child and Maternal Health Hay BERD Carlson CTRC Core Labs Accurso, Maier Community Engagement Nease Research Data Management and Integration Kahn NeTT Geraci Practical Trials and Dissemination/Implementation Morrato RED = Program Income System
Specific AimsCCTSI 2.0 Overarching Aim for the R&S Program: • Develop and implement a Program Income System and an evaluative process for cost-effective allocation of resources that support planning, conduct, analysis, and dissemination of research results. Additional Aims are focused on specific components of the R&S Program.
Outline • New Governance Model • Funding
Funding • Most components of the R&S Program will have budget decreases from Year 1 to Year 5 that reflect the declines in the CTSA budget • The intent is to cover the resulting budget deficits with Program Income and institutional support We do not have enough….
UCH CTRC Budget • By Year 5, revenue will have to be approximately $1.1M to support current level of activity • Based on current number of active UCH protocols (162), this is $6,791 per protocol
CTRC Core Lab Budget • By Year 5, revenue will have to be approximately $550,000 to support the UCH lab and $500,000 to support the CHCO lab • In 2013, the UCH and CHCO lab generated $115,000 and $85,000
Outline • New Governance Model • Funding • Scientific Protocol Review
Scientific Protocol Review • The CCTSI Scientific Advisory and Review Committee (SARC) meets the 1st and 3rd Mondays of the month • Applications are due 2 weeks in advance of the meeting • Feasibility review (by CTRC units, including administrative core) occurs before the meeting • Unfunded and underfunded protocols are not reviewed • Protocol may undergo full SARC review or E-review
SARC review: • Protocol is reviewed by a SARC chair, 2 scientific reviewers, and biostatistician • PI (or representative) is encouraged to attend the meeting • Stipulations and suggestions for revisions are generally sent to the PI in <1 week
E-review: • Multi-site trials that have undergone peer review and include detailed statistical analysis plan and DSMP • SARC chair and relevant CTRC units review the protocol within 1 week • Protocol is approved or rejected (no stipulations or suggestions)
After Protocol is Approved by SARC: • CTRC Navigator will assist with preparation of COMIRB documents • Navigator does final review and submission of COMIRB documents • This eliminates the COMIRB pre-review process (~3 weeks) and the protocol goes on the next available meeting agenda
Upcoming Changes: • More streamlined submission process – single portal of entry for all clinical protocols • All protocols will undergo scientific review, not just CTRC protocols • SARC membership will be expanded
Outline • New Governance Model • Funding • Scientific Protocol Review • Program Income System and Tracking
Program Income System and Tracking • CTR R&S components that are expected to generate revenue will operate as university service centers • Charge masters have been (are being) developed • A new core management system will (iLab Solutions): • Allow investigators to order services via web interface • Facilitate invoicing of services directly in PeopleSoft • Distribute invoices to users via e-mail • Enable cores to manage list of services and pricing • Facilitate centralized reporting of utilization
Core Management System • Will be utilized by CCTSI and UCCCC Cores (and possibly SOM) • Meeting on 9 December 2013 for Core Directors and Managers was very well attended • Most Core Directors are enthusiastic about the new system • Several offered to be in the first wave of implementation • Tracking utilization
Outline • New Governance Model • Funding • Scientific Protocol Review • Program Income System and Tracking • MicroGrants Program
MicroGrants Program The implementation of a fee-for-service model for the CTRC Network may result in decreased utilization, especially by junior investigators. The intent of the MicroGrants Program is to prevent this. The MGs can be used to pay for CTRC services • Nursing, nutrition, core lab, ECG, vascular imaging, exercise testing, DXA, UCH/CHCO clinical charges, etc • Cannot be used for outside invoices (e.g., specialized supplies, Core labs not supported by the CCTSI) • Separate program for Biostatistical support (BERDSeeds)
MicroGrants - eligibility and application • Junior faculty (assistant professor, instructor), fellows, postdocs • Applications from Senior faculty may be considered under some circumstances • Only PIs using UCH or CHCO CTRCs may apply • Application consists of checking a box on the CTRC Utilization Form
CTRC MicroGrants Program Duration of support • Up to 3 years Maximum amount of awards • $5,000/y through June 30, 2014 • $7,000/y through June 30, 2015 • $10,000/y through June 30, 2018 Unspent funds cannot be carried forward without permission Awards for 2nd and 3rd years will be dependent on demonstration of progress
Questions for EAC • How has utilization of R&S changed in response to the transition to fee-for-service at your institutions? • Is it problematic if the fee structure for a service differs by institution? • Do you have experience with a Core Management System and the potential challenges of bringing it online?
