Cancer Institute

Samuel Oschin Comprehensive Cancer Institute

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OnCore and Clinical Trial Informatics

Clinical Trial Informatics

The Clinical Research Office provides informatics support for protocol activation, tracking, accrual monitoring, and database development.  In addition, through collaboration with the Research Informatics and Scientific Computing Core (RISCC) custom databases and tools can be developed to support clinical research efforts.  

OnCore ™ Clinical Trial Management System

Overview

The Samuel Oschin Comprehensive Cancer Institute (SOCCI) utilizes the OnCore™ clinical trial management system (CTMS) to track our portfolio of cancer clinical trials. OnCore™ is a secure web-based system licensed from Forte Research Systems®. The system is housed at the Medical Center's secure Data Center and is compliant with applicable laws and regulations.

Purpose

OnCore™ provides for efficient and secure organization of data in a centralized repository so that trials can run more smoothly. Automated tools within OnCore and ongoing integration efforts with the institutional electronic medical record (CS Link) and IRB system (Webridge) provide consistency, compliance, and provide the user with access to protocol details and subject information in a timely manner.

OnCore™ empowers the research community by providing systematic way of tracking, accessing, monitoring and reporting on overall clinical trial activity and productivity.

Basic Components

Protocol registration
  • Single database to access and track all cancer protocols
  • Follow protocol through life of the study
  • Metric reporting (i.e. activation timelines)
  • IRB & Scientific review documentation
  • Interface with electronic medical record
Subject registration
  • Consent, screening, registration, eligibility and subject status
  • Interface with electronic medical record
Calendars & visit tracking
  • Tracks procedures, assessments, treatment and visit schedules
  • Outlines standard of care or research procedures
  • Facilitates accurate clinical trials / research billing and timely payments
Financial management
  • Budgeting, coverage analysis
  • Invoice generation, receivables tracking
  • Financial reporting
  • Unplanned visits/procedures, exceptions

Access

Access to OnCore™ is granted through the CSMC Service Center.

Training

Personalized training for OnCore™ is available by contacting GroupSOCCICROAdmin@cshs.org. 

System documentation, manuals and work instructions can be accessed at the CRO Sharepoint site.

Protocol Prioritization Committee (PPC) Online System

PPC Online system is a web-based platform that facilitates the submission of new protocols to the SOCCI prioritization committee. The system auto-generates key data for committee consideration, manages the committee’s review process and online discussions. The system interfaces with the clinical trial management system, OnCore, and helps to streamline operations and eliminate duplicity. The PPC system is managed by the PRMS coordinator and access may be granted by emailing the coordinator directly.

Research Electronic Data Capture (REDCap)

REDCap is a robust, secure web application for building and managing data for research studies developed and managed by Vanderbilt University and hosted by Cedars Sinai. Our highly qualified research staff are trained to develop case report (CRF) and other forms within the system to support investigator initiated research projects. Our team of experts work with investigators, statisticians, and other key stakeholders to create and maintain study specific e-CRFs that are compliant with HIPAA and 21CRF Part 11. Access to REDCap is granted through the CSMC Service Center.

Protocol Rapid Activation Tool (PRAT)

The Protocol Rapid Activation Tracking (PRAT) is a web-based application. This collaborative tool provides a single platform for all key stakeholders to manage, track and prevent bottlenecks, while simultaneously monitoring and measuring adherence to the activation timetable. The activation timetable and corresponding milestone deadlines are automatically generated based on the project start date. The PRAT system’s user-friendly web interface is based on the need to identify real-time delays through links to Forte’s OnCore™ and Huron’s Click™ IRB system. Key features of the system include two dynamically generated Gantt charts based on the distinct work streams and eight interwoven workflows. The system is currently used to manage studies that have been selected by the Protocol Prioritization Committee (PPC) to utilize the rapid activation mechanism for study start up. More information may be found at: https://www.protocolrapidactivation.org/prat/. Please contact the Research Manager with any questions or to request access.

Research Informatics & Scientific Computing Core (RISSC)

The research informatics core is a shared resource at Cedars Sinai who provides a wide variety of services including software and web-based applications to facilitate cancer research. More information about services can be found at the RISCC webpage. The clinical research informatics core work with RISC to create applications that support investigator initiated research and clinical research operations.