Clinical Protocol and Data Management

Wayne State University, Detroit MI

Investigators

Linked publications & trials

Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) - ABSTRACT The Karmanos Cancer Institute (KCI) Clinical Trials Office (CTO) serves as a centralized resource providing CPDM services and support to the Cancer Center with the highest priority being the safety of participating patients. The CTO provides comprehensive regulatory support from protocol conception to termination, including communication with sponsors and other stakeholders to facilitate timely initiation and completion of clinical trial activities, submissions to the Institutional Review Boards (IRBs), Investigational New Drug (IND) support, registration of new trials with the National Cancer Institute (NCI) Clinical Trials Reporting Program (CTRP), and appropriate registration and results reporting with ClinicalTrials.gov. CPDM services facilitate and optimize accrual by providing centralized data management and clinical research nurse support to KCI physician investigators and clinical support staff. The Clinical Trial Management System (CTMS) OnCore™ is utilized to centrally manage all protocol-related data, documents, and status reports. The CTO supports National Clinical Trials Network (NTCN), NCI-funded peer-reviewed, investigator-initiated, and industry sponsored protocols. KCI/Wayne State University (WSU) is a Lead Academic Participating Site under the NCTN (UG1CA233163). Effective quality control and education is provided by the CTO to ensure compliance with the NCI-approved Data and Safety Monitoring Plan (DSMP). This includes coordination and administrative support for the Feasibility Review and Operations Committee (FROC), Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC), and the Quality Assurance Committee (QAC). Over the current grant period, the CTO has strategically used CCSG funds to enhance the trial activation process, allowing us to surpass the NCI-recommended activation goal of 90 days; identify and close low-accruing trials; expand Network activities; support investigator-developed research; and implement new systems and technology to support quality research throughout the trial life cycle. The number of CTO staff has increased from 154.5 FTE to 164.75186 FTE, providing CPDM services in support of over 500 active protocols at any one time across the KCI Network. Enhancements to the CTO New Employee Orientation Program facilitated rapid onboarding and training for personnel as the CTO has resumed pre-COVID-19 pandemic operations. A restructuring of the Regulatory team allowed our regulatory coordinators to specialize in their role, which has led to increased job satisfaction and supported the decreased activation timelines. KCI supports multiple, proactive efforts to address the population of our catchment area.