Joint Clinical Trials Office (JCTO) Informational Update December 2013
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Transcript of Joint Clinical Trials Office (JCTO) Informational Update December 2013
Joint Clinical Trials Office (JCTO)Informational Update
December 2013
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Agenda• 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 NewYork-Presbyterian 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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WCMC NYPH
Assistant Dean, Research Integrity
Mary Simmerling
Associate Director, General Clinical Trials Operations
Erica Love
Director, Cancer Clinical Trials Operations
Alicia Lewis
Director, Business Operations
Aleta Gunsul
Organizational Structure
Associate Dean,Clinical Research
John Leonard
IRBData Safety/Monitoring
Conflicts of Interest
RegulatoryInvestigator Support
Operations Training
QAFeasibility
Finance/BudgetingMetrics
ContractsCommunications
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
• Common Findings – Insufficient statistical plan – Inadequate description of study design
68%
27%
4%
Result at 1st Review
Approved
Approved with Con-ditional Changes
Revisions Required
93%
3% 3%
Result at 2nd Review
Approved
Approved with Conditional ChangesRevisions Required
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Clinical Study Evaluation Committee (CSEC)
Medicine - H
ematology
& Medica
l Oncology
Pediatric
s
Medicine - G
astroenterology
& Hepatology
Neurology
Radiology
Surge
ry
Urology
Medicine - I
nfectious D
isease
s
Otorhinolaryn
gology
Medicine - C
ardiology
Public Healt
h
Obstetri
cs & Gyn
ecology
Pharmacy
Psychiat
ry - P
ayne W
hitney
Anesthesio
logy
Medicine - N
o Division Sp
ecified
Psychiat
ry - W
estcheste
r
Cardiothorac
ic Surge
ry
Neurological
Surge
ry
Dermato
logy
Genetic Medicin
e
Medicine - C
linica
l Epidemiology
& Evalu
ative
Sciences R
esearch
Ophthalmology
Rehabilit
ation M
edicine
Rogosin
Insti
tute
Administrati
on
Medicine - E
mergency
Medicine
Medicine - E
ndocrinology,
Diabetes &
Metab
olism
Medicine - G
eriatri
cs & Gerontology
Nursing
Pathology
Radiati
on Oncology
0
5
10
15
20
25
30 28
14
10 10 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 1
Submissions by Department/Division
Department/Division
# of
Sub
miss
ions
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
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Business Operations• Group Overview
– Finance – 2 financial analysts and research finance manager– Contracts – 3 dedicated contracts specialists and contracts administrator
• Current services– 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?– 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 Checks if Appropriate
Protocol Exists
OBC Attaches Case to Subject
in GE
OBC Sends Confirmation Email to the Department
Department Links
Appointment to the Subject’s
Case
Department Submits Subject
Enrollment Jira Ticket
No
Yes
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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 Checks if Appropriate
Protocol Exists
OBC Attaches Case to Subject
in GE
OBC Sends Confirmation Email to the Department
Department Links
Appointment to the Subject’s
Case
Department Submits Subject
Enrollment Jira Ticket
No
Yes
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Current Workflows with CREST and Epic
OBC Enrolls Subject in CREST
OBC Sends Confirmation
Email to Department
Department Links Encounter
to Subject Enrollment
eIRB CREST
Protocol
Information
Protocol
Information
Department Submits Subject
Enrollment Jira Ticket
SubjectEnrollment
Epic
OBC Enters Additional Study
Data
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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: [email protected]
• Contracts: [email protected]
• Clinical Trial Operations: [email protected]
• Clinical Study Evaluation Committee:
– General: [email protected]
– Cancer: [email protected]
• IRB: [email protected]