Joint Clinical Trials Office (JCTO) Informational Update December 2013

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

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.

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

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

Clinical Study Evaluation Committee (CSEC)

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 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

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

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

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

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 Email to the Department Department Links Appointment to the Subject’s Case

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 Email to the Department Department Links Appointment to the Subject’s Case

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 Email to Department Department Links Encounter to Subject Enrollment

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

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