1. Joint Clinical Trials Office (JCTO)
Informational Update
December 2013

2. 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

3. 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.

4. Organizational Structure
WCMC
NYPH
Associate Dean,
Clinical Research
John Leonard
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
IRB
Data Safety/Monitoring
Conflicts of Interest
Regulatory
Investigator Support
Operations
Training QA
Feasibility
Finance/Budgeting
Metrics
Contracts
Communications
Liaison
Information Technology
Billing Compliance

5. 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 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

6. Clinical Study Evaluation Committee (CSEC)

7. 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

8. Business Operations Group Overview Current services
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

9. 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

10. 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

11. 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

12. 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 No
OBC Checks if Appropriate Protocol Exists
Yes
Department Submits Subject Enrollment
Jira Ticket
OBC Attaches Case to Subject in GE
OBC Sends Confirmation to the Department
Department Links Appointment to the Subject’s Case

13. 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 No
OBC Checks if Appropriate Protocol Exists
Yes
Department Submits Subject Enrollment
Jira Ticket
OBC Attaches Case to Subject in GE
OBC Sends Confirmation to the Department
Department Links Appointment to the Subject’s Case

14. Current Workflows with CREST and Epic
Protocol
Epic
eIRB
Protocol
Information
Information
Subject
Enrollment
OBC Enters Additional Study Data
Department Submits Subject Enrollment
Jira Ticket
OBC Enrolls Subject in CREST
OBC Sends Confirmation to Department
Department Links Encounter to Subject Enrollment

15. 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

16. Contact Us Finance: JCTOFinance@med.cornell.edu
Contracts:
Clinical Trial Operations:
Clinical Study Evaluation Committee:
General:
Cancer:
IRB: