Wayne State University

Aim Higher

School of Medicine

OnCore

OnCore® is a Clinical Trial Management System (CTMS) that has the ability to manage all components of a clinical trial in one central location. The software has the capacity to manage multi-site trials both nationally and internationally. The Oncore CTMS is managed through the WSU CRC; it is utilized university wide to support all aspects of clinical trials as the software has been adopted by faculty and staff in many Departments.

Training and competency assessment are required to use the OnCore CTMS. Training occurs at least once a month and may be scheduled on other dates upon request.

 



What Are the Benefits?

Increased Efficiency and Communication:  OnCore helps streamline and centralize clinical trial operations.  Having all protocol information available in one location and easily accessible by study personnel enables research teams to more efficiently manage trials with limited resources.  OnCore can assist with simplifying workflows and establishing 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 Internal Review Boards and Food and Drug Administration, 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 trials.  OnCore will allow for future integration with Wayne State University's Institutional Review Boards once their electronic system has been implemented. 

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 needs.

Financial Management:  OnCore allows for consistent financial tracking across clinical and research environments.  It provides a framework for building budgets and tracking budgets and allows for real-time payment reconciliation. It allows you to distinguish between standard of care and research-related activities, and can also be used to generate a billing grid as well as generate a report based upon services.

Multicenter 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 trial.  This helps to ensure that the data is protected while facilitating communication between the coordinating center and their affiliates.

Data Security:  Data entered into OnCore is stored behind University firewalls in a secured Oracle database that is maintained by UITS.  All participant information contained in OnCore is strictly confidential and is treated as Protected Health Information, as defined in 45 CFR 164.501.

Data Management:  OnCore has the ability to track and store participant information including clinical data.  Utilizing a centralized clinical trial management system for this purpose reduces unnecessary development of single purpose excel or access-based management tools that lack inter-connectivity to each other and the University systems.  Utilizing 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 biostatistical analysis as required for investigator initiated trials.

Increased Regulatory Compliance:  Regulatory information can be tracked for each individual protocol.  This includes, but is not limited to, submissions and approvals from the Internal Review Boards, Detroit Medical Center, 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.

 

 

Register for OnCore Account