OnCore CTMS (Clinical Trials Management System)

Purpose

The ISMMS Clinical & Translational Science Award (CTSA), ConduITS, was awarded a supplemental grant to establish a Clinical Trials Management System (CTMS) for the Mount Sinai Health System (MSHS). The CTMS is a centralized, web-based technology solution for the management of clinical trials. The chosen software is OnCore, a product of Advarra, which has been successfully implemented in the Tisch Cancer Institute.

In addition to this expanded program, the Office of Research Services (with support from CTSA and ISMMS) is delighted to provide its research community dedicated support and centralized services through its OnCore Central Team.

Current Mandated Use (Non-Cancer)

• All prospective non-cancer-related human subject research studies with a billable service. A billable service is defined as services or procedures provided during a research study that are eligible for billing to patients, insurance, or grants.
  • Interventional studies with a billable service will use Subject Milestones.
  • Non-interventional studies with a billable service will be marked in OnCore as ‘Summary Accrual Info. Only’ as long as they do not require the use of Participant Payments for paying Subject stipends.
• The OnCore Central Team will submit studies to Epic for the research build.

Current Optional Use (Non-Cancer)

• Research teams may opt to have any other human research studies (such as registries, biobanks, surveys, etc.) built-in OnCore. However, they must be specifically requested using the OnCore and Payments Service Desk.

Impact

Department level enhanced and transparent study management functions:

• Protocol & subject life cycle management.
• Subject visit tracking.
• Regulatory compliance.
• Research billing compliance
• Sponsor Budget/Invoicing Management.
• Automated notifications.
• Task management.
• Reporting.
• Security – HITECH compliant & customizable security & access roles.

Benefits

• Holistic approach to organizational strategic planning based on enterprise-wide reporting & analytics.
• Integrated applications to reduce redundant data entry and the creation of an innovative research digital ecosystem.
• Standardization of business processes to meet compliance requirements & audit readiness.
• Real-time access to central clinical trial information at local & remote sites.
• Establish consistency of administrative, operational & financial aspects of trials across the MSHS.
• Increase efficiency of trial management and reduce trial-related costs.
• Provides comprehensive tracking & reporting functionality for subjects, documents, financials and compliance.

Department

Office of Research Services (ORS)

System Link

OnCore

IMPORTANT: OnCore is a firewall protected website. You must use an MSHS on-site computer or connected to the MSHS VPN if accessing remote/off-site.

Access and Training

OnCore eLearning Training Modules on PEAK are required for all non-cancer research personnel.

Download the OnCore Service Desk Flyer for information regarding the request of user access and required training for OnCore.

Training Requirements

• All Users must complete the OnCore Overview course.
• Additional courses required depending on OnCore permissions needed for entering data:
  • Permission to manage Protocol details such as Protocol Status, IRB Review info, and Staff
    • OnCore – Protocol Management (Basic)
    • OnCore – RUTH Integration
  • Permission to enroll subjects and enter required subject milestones (Consent, Eligibility, On Study, Off Study)
    • OnCore – Subject Management (Basic)
  • Permission to enter Subject Visit Tracking using the Subject Calendar (If your protocol uses a Protocol Calendar)
    • OnCore – Subject Calendars (Advanced)
    • OnCore – Subject Management (Advanced)

PEAK Access and Certificate Upload Instructions

1. Open PEAK
2. Search “OnCore” in the catalog.
3. Download all necessary Certificate(s) of Completion role-based training. The certificate can also be found under your transcripts.
4. Open an OnCore Service Ticket at OnCore User Access – Create New User and upload your Certificate(s) of Completion.

Support

The OnCore Central Team (OCT) is a dedicated support unit housed within the Office of Research Services providing centralized OnCore services and support for non-cancer research at Mount Sinai.

Their charge includes:

• User Access Management
• Development and Maintenance of the OnCore Training Program
• Quality Management and Data Monitoring of the OnCore Minimum Footprint
• Technical Support/Issue Resolution
• Best Practice Recommendations
• Integration Management

OnCore CTMS Support (Non-Cancer)
OnCore Service Desk

ORS OnCore Central Team
ORS.OnCore@mssm.edu

Tisch Cancer Institute Training and Support (Cancer)
TCI OnCore/Florence Support Ticket