Joint Clinical Trials Office (JCTO)
Informational Update
December 2013
Agenda
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Introduction
Clinical Study Evaluation Committee (CSEC)
Research Integrity
Business Operations
Clinical Trial Operations
Architecture for Research Computing in Health (ARCH)
Clinical Research Enrollment and Study Tracking (CREST)
system
• Website
• Contact Information
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Introduction
The Joint Clinical Trials office is a collaborative enterprise
between Weill Cornell Medical College and NewYorkPresbyterian Hospital to foster and advance clinical research.
• Launched in January 2013 to address the need to provide
support to investigators involved in clinical research.
• Actively engaged in optimizing operating efficiencies and
offering a diverse range of support services intended to
increase the number, quality and impact of our clinical trials.
• Provides infrastructure for investigators and study teams in
the areas of contracting, finance, research integrity, study
activation, training and development, social media, and
community outreach, all under one umbrella.
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Organizational Structure
WCMC
NYPH
Associate Dean,
Clinical Research
John Leonard
Assistant Dean,
Research Integrity
Associate Director, General
Clinical Trials Operations
Director, Cancer Clinical
Trials Operations
Director,
Business Operations
Mary Simmerling
Erica Love
Alicia Lewis
Aleta Gunsul
IRB
Data Safety/Monitoring
Conflicts of Interest
Regulatory
Investigator Support
Operations
Training
QA
Feasibility
Finance/Budgeting
Metrics
Contracts
Communications
Liaison
Information Technology
Billing Compliance
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Clinical Study Evaluation Committee (CSEC)
• Launched institution wide on August
15, 2013
• Mission
– To provide peer review of each protocol and
deliver feedback to investigators that will
improve the quality and impact of their
studies.
– The CSEC has two main functions:
• to review a study for scientific merit
• to review a study for feasibility
• Activity
– 2 General and 1 Cancer Committee
– 165 submissions received
– Average time to 1st review is 10-11 days
with 68% of studies approved at 1st review.
– Time to review expected to decrease with
launch of 3rd general committee in January
– 45% of submissions are unfunded
Result at 1st Review
5%
Approved
27%
68%
Approved with
Conditional Changes
Revisions Required
Result at 2nd Review
4%
3%
Approved
93%
Approved with
Conditional Changes
Revisions Required
• Common Findings
– Insufficient statistical plan
– Inadequate description of study design
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Clinical Study Evaluation Committee (CSEC)
Submissions by Department/Division
30
28
# of Submissions
25
20
15
14
10 10
10
5
9
9
9
8
7
6
6
5
5
5
4
4
4
3
3
2
2
2
2
2
2
1
1
1
1
1
1
0
Department/Division
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1
Research Integrity
• July 2013 – Implementation of 5 specialized IRBs
– Cancer (2)
– General (2)
– Expedited protocols (1)
• Changes in COI requirements and (dis)connection of the COI
and eIRB systems
• New initiatives for 2014
– Reduce deferral rates by working with researchers pre-IRB review
– Work closely with the new Director of Research Admin IT to make
improvements to the IT systems related to IRB and COI
Business Operations
• Group Overview
– Finance – 2 financial analysts and research finance manager
– Contracts – 3 dedicated contracts specialists and contracts administrator
• Current services
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–
–
–
–
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Contract negotiations
Budget review
Account and Plan Code creation
Revenue processing
Start-up fee and IRB renewal and amendment invoicing
Hospital research bill management
• Changes implemented
– Substantially decreased turnaround time of account and plan code creation
– Increased frequency of check and wire allocations for faster revenue recognition
• Future plans
– ClinCard for subject stipend and reimbursements
– Centralized tracking and reporting of revenue
– Decrease contract execution turnaround time
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Clinical Trial Operations
• Group Overview
– General
– Cancer
• Current Services
– Subject recruitment
– Assistance with navigating the study activation process
– Support for audit preparation and response
• Future plans
– Investigator and coordinator training programs
– Analysis of need for centralized clinical research core
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Architecture for Research Computing in Health (ARCH)
• Designs Research Data Repositories (RDR) to grow and support
multidisciplinary research.
– Empowers faculty, providers, and researchers by making data readily available to
facilitate clinical care, research, and educational activities
– Improves and standardizes data management practice, policy, and compliance
– Creates valuable reusable “Data Assets”
– Improves the impact and visibility of quality improvement, patient safety, education, and
research programs
– Facilitates collaborations and increase efficiency
– Helps generate new ideas and discoveries
– Helps secure funding and meets funding agency data management requirements
• What services does ARCH provide?
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–
–
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Assess RDR needs
Provide technology and software
Integrate data sources
Manage and curate data
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CREST and Subject Enrollment
• Implemented Clinical Research Enrollment & Study
Tracking (CREST) as of June 13, 2013
• Modified existing workflows for GE Case Module and
GE Protocol Dictionary to incorporate CREST
• Replaced GE Case Module and GE Protocol
Dictionary with CREST completely as of October 1,
2013
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Former Workflows with GE Case Module
OBC Runs
Report to Find
New Protocols
OBC Requests
Creation of
Protocol from
POBO
POBO Creates
Protocol in GE
Protocol
Dictionary
POBO Confirms
Protocol
Creation with
OBC
OBC Sends
Confirmation
Email to the
Department
Department
Links
Appointment to
the Subject’s
Case
No
OBC Checks if
Appropriate
Protocol Exists
Yes
Department
Submits
Subject
Enrollment
Jira Ticket
OBC Attaches
Case to Subject
in GE
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Changes to Workflows with GE Case Module
OBC Runs
Report to Find
New Protocols
OBC Requests
Creation of
Protocol from
POBO
POBO Creates
Protocol in GE
Protocol
Dictionary
POBO Confirms
Protocol
Creation with
OBC
OBC Sends
Confirmation
Email to the
Department
Department
Links
Appointment to
the Subject’s
Case
No
OBC Checks if
Appropriate
Protocol Exists
Yes
Department
Submits
Subject
Enrollment
Jira Ticket
OBC Attaches
Case to Subject
in GE
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Current Workflows with CREST and Epic
Protocol
Protocol
eIRB
Information
Information
CREST
Epic
Subject
Enrollment
OBC Enters
Additional
Study Data
Department
Submits
Subject
Enrollment
Jira Ticket
OBC Enrolls
Subject in
CREST
OBC Sends
Confirmation
Email to
Department
Department
Links Encounter
to Subject
Enrollment
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Website
• Timeline – scheduled to launch in early 2014
• Goals of site
– Provide central resource and guidance for investigators
and study teams
– Publicize and promote active clinical trials
– Streamline process for industry collaboration
• Researcher’s toolbox
– Tips for study activation process
– Tools and templates for study conduct
– “How to” presentations, webinars and videos
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Contact Us
• Finance: JCTOFinance@med.cornell.edu
• Contracts: JCTOContracts@med.cornell.edu
• Clinical Trial Operations: JCTOOperations@med.cornell.edu
• Clinical Study Evaluation Committee:
– General: GeneralCSEC@med.cornell.edu
– Cancer: CancerCSEC@med.cornell.edu
• IRB: irb@med.cornell.edu
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