As of November, 2021, every participant in IRB clinical trials must be entered into the OnCore CTMS. Please email OCR at email@example.com if you have questions about OnCore.
Frequently Asked Questions
- What is OnCore?
- OnCore is a Clinical Trial Management System, also known as CTMS, that tracks patient participation and protocol events throughout the lifecycle of a given project.
- Calendars in OnCore track patient participation and allow for a unidirectional passing of this information to the invoice team for sponsor billing where applicable.
- OnCore includes a robust and comprehensive financials console that allows for financial management, coverage analysis, milestone tracking, and invoicing. Not only does it act as a billing and milestone safeguard but will also be critical for tracking of research services.
- What studies go into OnCore?
- All clinical trials involving human subjects are required to be managed in OnCore
- All trials with financial tracking will be required to be entered in OnCore
- What is the purpose of OnCore?
- Simplify clinical trial management and study subject tracking for study teams.
- Improve the overall research process, patient safety, subject enrollment, and reporting of research information (e.g., study activation, statuses, and accrual metrics).
- Streamline tracking and management for sponsor invoicing and payment reconciliation.
- Improve the accuracy of billing for research and standard-of-care procedures.
- Who is responsible for putting new studies into OnCore?
The responsibility for entering studies in OnCore typically falls on the research coordinator. These individuals are responsible for setting up the study in OnCore, which involves entering all relevant study information, including study protocols, study budgets, and participant schedules.
Here are some specific responsibilities for entering studies in OnCore:
- Setting up study protocols: The research coordinator or data manager is responsible for entering the required study details and releasing the task lists in OnCore.
- Setting up participant schedules with OnCore Project Manager and MFA Business Operations Unit: The research coordinator or data manager is responsible for confirming participant schedules in OnCore. This involves setting up visit schedules, specifying the activities at each visit, and setting up alerts and reminders for participants and study staff.
- Setting up study budgets with OnCore Project Manager and MFA Business Operations Unit: The research coordinator is responsible for confirming study budgets in OnCore. This involves specifying the costs associated with each study activity, including participant visits, lab tests, and study materials.
- Data collection: The research coordinator is responsible for data collection in OnCore. Entering study data requires attention to detail and a thorough understanding of the study protocols and procedures. The research coordinator must work closely with other research team members to ensure that all study information is accurately entered into OnCore.
- How do I receive access to OnCore?
All users must complete mandatory training before receiving access to the OnCore system.
- To request training, please complete the Access Request Survey
- Wait for the OnCore Application Administrator to reach out with next steps
- You will need GW credentials (a GWID and GW email address) in order to access OnCore. It’s best to have these credentials before scheduling training.
- Schedule live training (virtual via Webex). Training usually lasts two hours.
- After successfully completing training, your OnCore account will be created.
- What are the main consoles in OnCore?
PC Console is a system component that allows study teams to manage various aspects of their clinical trials. It provides access to study-related data, study calendars and budgets, subject enrollment, and the schedule of events. The centralized location for study-related data allows study teams to easily access and manage all aspects of their study from a single location.
CRA (Clinical Research Associate) Console is a component of the system that is designed to support the activities of CRAs, who are responsible for monitoring and ensuring the quality of clinical trial data. The CRA Console allows CRAs to manage various monitoring activities, including reviewing subject data and tracking study progress.
Coverage Console is a module that assists with managing financial billing and coverage analysis for clinical research studies. It provides tools to help researchers and administrators determine the costs associated with a study, negotiate coverage with sponsors and payers, and ensure compliance with regulations and policies.
- What are the main features and capabilities of OnCore?
- Protocol management: OnCore provides a comprehensive platform that enables all aspects of the protocol development process, including document management, version control, and study team collaboration.
- Subject management: With the help of OnCore, study teams can easily monitor subject enrollment, scheduling, and tracking, as well as capture and manage data from various sources.
- Study calendar and budget: The OnCore platform allows for the creation and management of study calendars and budgets, including the ability to track study-related expenses and generate financial reports.
- Regulatory compliance: OnCore offers tools to assist with regulatory compliance, such as managing documentation, tracking training and certifications, and facilitating institutional review board (IRB) submissions and approvals.
- Metrics reporting: OnCore helps with data collection and analysis related to study performance, including subject accrual, protocol deviations, and study financials.
- Integration with other systems: OnCore integrates with various systems and applications, including electronic medical records (EMR), billing, and payment systems.
- User access and permissions: OnCore grants specific user access and permissions to ensure appropriate control of sensitive study data.
- What are some benefits and advantages of using OnCore?
- Centralized management: OnCore provides a centralized platform to manage all aspects of the clinical trial process, from protocol development to subject enrollment, data management, and study reporting.
- Streamlined workflows: OnCore streamlines workflows and reduces the burden on research staff, allowing them to focus on higher-level tasks and improving study efficiency.
- Real-time data access: OnCore provides real-time access to study data, enabling more informed decision-making and improved study outcomes.
- Improved financial management: OnCore allows for the creation and management of study budgets, including the ability to track expenses and generate financial reports.
- Improved communication: OnCore facilitates study team communication and collaboration, improving overall study efficiency and reducing the risk of errors or miscommunication.
- Customization and flexibility: OnCore can be customized and configured to meet the specific needs of individual institutions and research programs, allowing for greater flexibility and scalability.
- Who should I contact for support?
OnCore Project Manager:
- Is responsible for overseeing the implementation of OnCore within an organization
- Helps study teams manage study activities and timelines, including configuring the system to match the study protocol, setting up study calendars and budgets, and ensuring that all regulatory and ethical requirements are met
- Ensures compliance with study protocols
- Oversees OnCore data management
- Serves as a point of contact for OnCore User Support
Epic Research and Ambulatory Analyst:
- Works closely with the OnCore team to ensure that the OnCore-Epic integration is configured and optimized to meet the needs of the research team
- Checks for accurate and efficient billing
- Verifies documentation of research-related activities in the electronic health record (EHR) system
- Troubleshoots and resolves HER system issues related to research studies
OnCore Support Team
OnCore Project Manager: Haneefa Willis-Johnson | firstname.lastname@example.org
Epic Research and Ambulatory Analyst: Zoe Foster | email@example.com
Sr. Manager Regulatory and Compliance: Sarah Ford-Trowell | firstname.lastname@example.org
REDCap is a HIPAA compliant, IRB- and GWU Compliance Office approved method of collecting and storing research data, including surveys and case report forms in an online database. There are other features to using REDCap, including audit trails, e-consent tools, the ability to directly export data to statistical packages, and integrating data with other applications such as tableau.
Online training is currently not mandatory but available if needed to new users. Register for training on the REDCap 101 Online Training Registration page. All new users must complete the REDCap Account Agreement Form. If you need help with REDCap, you can email their support team at REDCap@gwu.edu or reach out to our REDCap administrator, Bryan Gerald at email@example.com.
- allow users to initiate and submit research protocols online;
- automate the workflow for review of protocols by staff and boards such as the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC); and
- provide collaborative tools for studies with multiple sites.
Cosmos combines billions of clinical data points in a way that forms a high quality, representative, and integrated data set that can be used to change the health and lives of people everywhere. Cosmos includes information from 200 Epic organizations, with the dataset containing more than 184 million patients and 7 billion encounters.
There are two types of Cosmos access:
- Cosmos SlicerDicer access is intended for users who have a research project use case that would benefit from access to summary-level national data.
- Cosmos Data Science access is intended for researchers and data scientists familiar with R, Python, and/or SQL who have a research or project use case that would benefit from access to deidentified national data. This access requires additional training at Epic headquarters in Verona, WI and only users with an articulable project or use case and prior R/Python/SQL experience should receive this level of access.
For more information, checkout the Cosmos website.
To request Cosmos access, please complete the Cosmos Access Request Form. Send completed forms to firstname.lastname@example.org.
Florence e-Consent is a 21 CFR Part 11, HIPAA, CCPA, and GDPR compliant system that is easy to use for researchers, subjects, and research monitors. With Florence you can easily invite participants into the e-Consent platform, monitor the status of participants’ informed consent in real-time, update to latest consent versions for new protocol amendments, distribute and track re-consenting in the same application, and more!
If you are interested in utilizing e-Consent for your future studies, please follow the steps below:
- E-mail Sarah Ford-Trowell (email@example.com) requesting an account be set up for you. The account has to be set up using your GW email!
- A member of the OCR regulatory team will register your account
- Register for ‘Florence Basics for Remote Site Access’ and complete the training here.
- Download the completion certificate, store it in your regulatory files, and send a copy to firstname.lastname@example.org.
- After the certificate is received by the OCR, an Attestation of Florence e-Consent Training Completion will be routed through Florence for your e-signature. Again, please download the document and save it in your regulatory files.