Research Policy and Procedure Task Force

Report to RAFJean S. Kutner, MD, MSPH

Chief Medical Officer, University of Colorado HospitalFebruary 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

FindingCommon 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 processFindings• 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 MonitoringStatus• 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