On this page you will find the following sections:
What is OnCore?
OnCore is a Clinical Research Management System (CRMS) developed by Forte Research Systems and developed in collaboration with leading research organizations. It is widely adopted by academic medical centers, cancer centers and health care systems alike. OnCore is currently being used by Indiana University in collaboration with our key research partners to record, manage and report on data associated with the operation of clinical research. The system is web-based and provides users secure access from any location. The OnCore software system is comprised of 3 specific applications: Clinical Research Management (CRM), Biospecimen Management (BSM) and Unified Registries Management (URM). A list of the basic OnCore functionalities within the CRM is presented below:
What Are the Benefits?
Increased Efficiency and Communication: OnCore helps streamline and centralize clinical study operations. Having all protocol information available in 1 location and easily accessible by study personnel enables research teams to more efficiently manage studies with limited resources. OnCore can help simplify workflows and establish standardized research management processes. It also reduces the need for paper files and improves organization by allowing for the upload and storage of regulatory and protocol related documents.
Increased Patient Safety: The Serious Adverse Events (SAE) and Data Safety Monitoring Committee (DSMC) management functionalities help improve reporting and communication regarding patient safety within and between protocols. These areas can be used to facilitate reporting to regulatory bodies such as the IRB and FDA or just track information for review by the study team. An integration is also in place that links OnCore with Cerner PowerTrials. This will allow patients to be flagged as research participants in the Cerner medical records system.
System Integration: The goal of system integration is to reduce the effort needed to manage clinical studies. Interfaces currently exist with Cerner to aid in patient safety and with INPC (Careweb) to aid in patient registration and data entry. OnCore will also allow for future integration with other clinical systems like Epic and research systems such as Kuali Coeus.
Multilevel Custom Reporting and Research Portfolio Review: OnCore increases the ability to run meaningful reports and track trends within and across multiple departments, divisions or specified management groups. It allows for quick and efficient reporting on protocol and subject information through the detailed search functions and provides a mechanism to track our clinical research portfolio at an organizational level. Canned (pre-defined) reports are available and custom reports can be created to view information within and across protocols based on your individual need.
Financial Management: OnCore allows for consistent financial tracking across clinical and research environments, providing a framework for building budgets and allowing for real-time payment reconciliation. It allows you to distinguish between standard of care and research-related activities and can also generate a billing grid for Medicare coverage analysis.
Multi-center Study Management: OnCore allows for users from external sites to enter their data directly into our secure, web-based system. User access can be limited to a specific institution and specific subjects while allowing for the coordinating center to manage all aspects of the study. This helps ensure data is protected while facilitating communication between the coordinating center and their affiliates.
Data Security: Data entered into OnCore is stored in a cloud-hosted environment with a secured Oracle database that is maintained by the IU Office of Clinical Research and the OnCore vendor, Forte.
Data Management: OnCore has the ability to track and store patient information, including clinical data. Using a centralized clinical study management system reduces the need for single purpose Excel or access-based management tools that lack inter-connectivity to each other and the University systems. Using OnCore for clinical data entry also allows for easy monitoring by a data management team and the ability to export data to SAS (and other formats, such as Excel and PDF) for bio-statistical analysis.
Increased Regulatory Compliance: Regulatory information can be tracked for each individual protocol. This includes, but is not limited to, submissions and approvals from the IRB and other specified boards or committees as well as general information on INDs and IDEs. Features also exist for uploading documents and providing them to staff members in a version-controlled environment.