Research Policy and Procedure Task Force Report to RAF Jean S. Kutner, MD, MSPH Chief Medical Officer, University of Colorado Hospital February 12, 2015

History Formed on November 28, 2015 at request of John Harney with the following goals and charge: – Goal: Promote research as a system priority, meeting needs of efficiency as well as regulatory and fiscal responsibility. – Charge: Make short, intermediate and longer term recommendations for achieving the goal, including: responsible individuals/groups, expected outcomes, longer term committee and composition and charge. First meeting 12/15/2014 Met 4 times between 12/15/14 and 1/28/15

Members Jean Kutner Barbara Carveth Tom Purcell Mark Kochevar Jamie Bachman Jennifer Holcomb Diane Branham Tim Lockie David Badesch Steve Van Nurden Alison Lakin Kim Meyers Marc Moss Elizabeth Collins Steve Hess

ISSUES ADDRESSED TO DATE

Acute issues: Trials pending Epic activation Finding Common reasons activation pending: Beacon build (Cancer Center) NCT# not entered LAPS – system-wide studies needing to be open in all 3 regions before accrual could begin in one Contract pending IRB pending Status Additional resources put towards completing Beacon builds Alison Lakin’s office tracking down and entering/helping PIs obtain NCT #’s Decision made that LAPS studies can begin accruing in the region where the study is activated.

Acute issues: UCH bottleneck = departmental review Finding Department managers/directors not included in reminders. No clear escalation plan. Three departments identified as resulting in the most number of delayed review/response. Status Department directors now included in communication regarding departmental review. Escalation to Barbara Carveth if delayed response from Department. Barbara Carveth meeting directly with the 3 problematic Departments. Steve Van Nurden and Alison Lakin joined Barbara in key meetings.

Acute issues: UCD bottleneck = contract execution Finding Of trials pending activation as of 1/28/15, 49 were pending contract execution Status Alison Lakin provided OGC with the list. Alison Lakin and Steve Van Nurden met with Amy Gannon on 1/28/15 to address.

Broader Issues: Complexity of the research protocol review process Findings Created flow diagrams that demonstrate each of the steps in the protocol approval process for 4 different types of studies. Identified “pain points” within the process. Identified that there is a lack of checks and balances across UCH/UCD to assure that protocols aren’t falling through the cracks.

Complexity of the research protocol review process across UCD and UCH Status Data demonstrated that bottlenecks are occurring at points across the entire research protocol review process.

Lack of key performance metrics and reporting across the entire protocol review process Finding With 2 separate platforms and databases, there is no easy way to see the status of individual protocols, or overall performance, across the entire process. Status UCH and UCD worked together to develop method for reporting of status of individual protocols as well as key performance indicators.

Performance Metrics and Monitoring Status Task Force agreed upon dashboard to track status for both individual protocols as well as for overall performance: – For activated protocols: time in IRB, OGC, RSS, time from approval to activation, total time in research review process. – For protocols awaiting activation: #, # days in the system. For the top 25% in terms of days in the system – in depth analysis of roadblocks with specific, identified action to address. UCH and UCD staff working on creating the dashboard. – Expected delivery 2/13/15. Goal = 60 days from protocol submission to study activation UCD and UCH working on a plan for ongoing checks and balances to monitor status of protocols in the process.

Communication Challenges Finding Investigators not aware of: – Changes in the processes – Why changes have been implemented UCH not able to post updates to its website, so all updates posted to UCD research website. Status Task Force created a subgroup on 1/28/15 charged with identifying: – Audiences – Messages – Means of communicating Engagement of RAF in facilitating communication with investigators

NEXT STEPS / DIRECTIONS

Enhancing Research = Top Institutional Priority Leadership Engagement Engagement of Don Elliman (CU) and Liz Concordia (UC Health) Jean Kutner (CMO) and John Harney (CEO) charged by Liz Concordia with enhancing research processes Action Items Approval for new Chief Clinical Research Officer position – Position description and org chart in development IT resource identification Developing recommendation for joint clinical trials office structure and function Task Force to continue to meet to provide oversight and direction

QUESTIONS AND DISCUSSION