Hub Research Capacity Participant & Clinical Interactions Wendy M Kohrt, PhD Associate Director

CCTSI Organizational Structure

PCI Specific Aims 2018-2023 Aim 4. Implement OnCore to manage and track all human subject protocols with more than minimal risk 4.1 Centralize management of protocol documents for coordinated reviews by the Scientific Advisory and Review Committee (SARC), Colorado Multiple Institutional Review Board (COMIRB), and other entities 4.2 Assess protocol resource needs and feasibility through the standardized development of the protocol calendar of events and budget

PCI Specific Aims 2018-2023 Aim 5. Develop the PCI Management Program that will provide oversight of centralized clinical research facilities and expand resources to improve the quality, efficiency, and safety of clinical research 5.1 Promote the use of centralized research facilities staffed by trained research nurses and technicians and expand mobile research capabilities within CHCO and UCH 5.2 Manage specialized clinical research resources that require unique facilities, equipment, and/or trained personnel to ensure the quality of data collection and efficiency and safety of operation 5.3 Expand the pool of centrally-managed research/trials personnel under a fee-for-service model, including research coordinators, budget specialists, and regulatory specialists

PCI Specific Aims 2018-2023 Aim 6. Ensure the high quality and scientific impact of the clinical research portfolio through rigorous review of scientific merit, monitoring of protocol benchmarks of success, and tracking of dissemination of results 6.1 Ensure high scientific merit of all protocols involving more than minimal risk to human subjects through peer review by SARC, populated by investigators from the CCTSI affiliates with broad scientific expertise 6.2 Utilize OnCore to monitor protocol-specific benchmarks of success (participant accrual/retention, adherence to the protocol, safety) and ClinicalTrials.gov to monitor updates and dissemination of results

Accomplishments Aim 4 Implement OnCore to manage and track human subject protocols Gradual changes have been adopted to move toward centralized management of protocol documents for coordinated protocol reviews by multiple entities New adult clinical protocols are now required to use OnCore and develop calendars of events and budgets for all services provided through the CTRC Network and hospitals CHCO is in the processing of changing to OnCore as the CRMS – all new protocols using OnCore – Jan. 2019

Accomplishments Aim 5 Develop the PCI Management Program that will provide centralized clinical research facilities and expand resources to improve the quality, efficiency, and safety of clinical research UCH and CHCO CTRCs each added 1.0 FTE of nursing support to increase mobile services and expand the availability of clinical research support. Installed Harvard Scheduler to streamline CTRC scheduling; a 1.0 FTE Scheduler Manager was hired and a 1.0 FTE General Scheduler will be hired. The Clinical Research Support Team (CReST; launched in April 2017) at UCH added 2 research coordinators (total of 6) and 1 on-site study monitor (new position); CReST supports 109 adult protocols from 15 departments and divisions. CHCO (Research Institute) has a separate pool of research coordinators (n=60), budget specialists, and regulatory specialists that are available to support pediatric protocols.

Accomplishments Aim 6 Ensure the high quality and scientific impact of clinical research through rigorous review of scientific merit, monitoring of protocol benchmarks of success, and tracking of dissemination of results SARC reviews all clinical research protocols at CU-AMC (and all CU-Boulder and NJH CTRC protocols) for scientific merit and helps junior investigators design high quality protocols. Initiated a new policy to engage all recipients of CTRC MicroGrants in SARC protocol reviews under the guidance of a SARC Chair. This approach increases the number of reviewers, provides training in grant review, and increases the breadth of expertise on SARC. Have not yet started using OnCore to monitor protocol-specific benchmarks of success (participant accrual/retention, adherence to the protocol, safety)

CTRC Active Protocols

New Protocols

CTRC Outpatient Visits

CTRC Inpatient Days and Visits

Oxygen Saturation (SpO2) Swan-Ganz catheter Transcranial Doppler Gas Exchange (VO2) BP by arterial line Oxygen Saturation (SpO2)

Core Lab Assays

Protocols Supported by Core Labs

Nutrition Core Activity

CTRC Revenue % values are percent of operating costs

Clinical Research Support Team

MicroGrants Program UCH CHCO Budget Awarded Spent Awards # Y1 $150,000   UCH CHCO Budget Awarded Spent Awards # Y1 $150,000 $79,968 $8,947 6 $300,000 $28,167 $1,128 2 Y2 $175,000 $470,276 $35,957 24 $182,704 $41,294 14 Y3 $200,000 $164,000 $253,593 12 $121,500 $66,761 13 Y4 $225,000 $168,300 $230,284 10 $168,700 $67,765 Y5 $250,000 $225,700 $135,215 $217,700 $207,385 Y6 $177,000 $126,050 9 $204,000 $45,206 Total $1.25M $1.29M $0.8M 75 $1.75M $0.9M $0.4M 61

CTRC User Satisfaction

CTRC User Satisfaction

CTRC User Satisfaction

CTRC User Satisfaction

CTRC User Satisfaction

CTRC User Satisfaction

PCI Governance Structure Director Wendy Kohrt Director of Operations Janine Higgins CTRC Administrator Pamila Allen UCH CTRC Medical Director Thomas Campbell Nurse Manager Diane Branham Perinatal CTRC Medical Director Chris Baker Nurse Manager Lisa Lewis NJH CTRC Medical Director Donald Leung Nurse Manager Susan Leung CHCO CTRC Medical Director Philip Zeitler Nurse Manager Lisa Lewis CU-B CTRC Medical Director Brian Stauffer Nurse Manager Debra Cody

National CTSA Consortium Involvement Participation in CTSA Consortium Working Groups Higgins, Lockie, Proctor – Common Metrics Initiative Kohrt – Methods & Processes DTF Hammack – GCP training CTSA-related collaborations Kohrt – UC Irvine Institute for Clinical and Translational Science Clinical Research Expert Committee for Terminology Harmonization in Exercise Medicine and Science (THEMES) MoTrPAC – NIH Common Fund initiative on Molecular Transducers of Physical Activity Consortium; utilizing Trial Innovation Network for single IRB; Colorado is a Clinical Center

Response to EAC Critiques “Metrics for success might include a balanced scorecard of academic productivity, finance and satisfaction of faculty, staff and research participants. A difficult question is whether the metrics should be kept on all studies or only those that touch the CCTSI.” Currently, these metrics are requested only from CCTSI members and participants in projects conducted on the CTRCs.

Response to EAC Critiques “One issue is capacity planning for study coordinators hired centrally. Management requires focus on both professionalism (promotions and salary) and an effort allocation system that promotes sharing of coordinator effort across projects.” CReST expansion space in current (and future) facilities is limited; leadership is aware of the situation Career advancement guidelines are in development Effort certification is completed through iLabs to capture activity on multiple projects In 2 years of operation, CReST has never turned down a request for service, including coverage for gaps or transitions in support, and can support a full range of services (project coordination, budget development, regulatory oversight, etc.)

Questions for EAC Research teams are complaining about duplication of effort with the use of OnCore. Some information recorded in OnCore must also be recorded in Epic, study-specific CRFs for the sponsor, and/or the research database. Do your institutions require that investigators use a CTMS? Are there any carrots to encourage (or sticks to discourage) participation? Do your institutions use a CTMS to identify struggling studies? If yes, does the CTSA provide study-specific rescue plans?