Joint Clinical Trials Office (JCTO) Informational

Transcript:Joint Clinical Trials Office (JCTO) Informational:
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 2 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. 3 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 IRB Data Safety/Monitoring Conflicts of Interest Regulatory Investigator Support Operations Training QA Feasibility Finance/Budgeting Metrics Contracts Communications Liaison Information Technology Billing Compliance 4 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 5 Clinical Study Evaluation Committee (CSEC) 6 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