OnCore CTMS (Clinical Trials Management System)

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 already been successfully implemented in the Tisch Cancer Center and was successfully implemented in 44 institutions throughout the country.

Why Now? 

• The increase of the MSHS’ portfolio of clinical trials with the integration of new hospitals.
• The need to coordinate clinical trials across multiple, remote MSHS hospitals with disparate management methods.
• The size and complexity of clinical trials throughout MSHS.

Benefits

• Holistic approach to organizational strategic planning based on enterprise-wide reporting & analytics.
• Integration of trial & subject data with Epic Electronic Health Record to streamline the processes for research staff & strengthen patient safety & billing compliance.
• 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.

Impact

• Electronic data capture & data management.
• Protocol & subject life cycle management.
• Subject visit tracking.
• Research billing compliance, budgeting & invoicing.
• Effort tracking.
• Task management.
• Reporting.
• Security – HITECH compliant & customizable security & access roles.

Phased roll-out of OnCORE by department

• Analysis of current workflow.
• Gap analysis.
• Identification of super-user for implementation and training.

Return on Investment

• Increased functionality, efficiency and compliance.
• Reduction of redundant and duplicative steps.
• Central access to study data & comprehensive overview throughout conduct of study.
• Standardization across multiple sites & the health-systems.
• Enhanced clinician/researcher awareness of study activities.

ConduITS and Research IT are working together to implement this enterprise-wide enhancement for the clinical research community. Periodic updates, communications and timelines via the research listserv will be shared to assist in your planning for this transition to a centralized electronic clinical trials management system.

If you have any questions please contact us via: OnCore Service Desk

Due to the COVID-19 pandemic, the enterprise roll-out of OnCore CTMS for Non-Cancer Related Research was put hold. Currently, the institution has resumed the implementation and updated the projected roll-out timeline. We are now ready to resume implementation. Below is a projected roll-out schedule. This is an aggressive timetable, as we understand that many of you are eager to start to utilize this system. We recognize that we may need to re-evaluate this timeline and we will keep you updated if any changes are needed.

October-January 2020 – COMPLETE	Wave 1: MCTO, Medicine Divisions
September-October 2020 (In Progress)	Wave 2: Genetics, Neurology, Transplant Institute
November-December 2020 (In Progress)	Wave 3: Pediatrics, Psychiatry, Radiology
January-March 2021	Wave 4: Cardiology, Cardiothoracic Surgery, Neurosurgery, Surgery
March-May 2021	Wave 5: Anesthesiology, Critical Care, Emergency Medicine, Health Policy, Obs/Gyn, Ophthalmology, Otolaryngology, Radiation Oncology, Rehab Medicine, Urology, Dermatology

In preparation for your department’s roll-out, please explore our institution’s eLearning Modules, Introduction to OnCore CTMS and OnCore CTMS Demo. To request access to these resources, please contact the OnCore CTMS Training Specialist, Brianna Wisniewski, brianna.wisniewski@mssm.edu.

1. OnCore CTMS Training Modules
   1. Protocol Creation & Set Up & Subject Management eLearning modules are also available and easily accessible for your team to view. The Protocols & Subjects Console will be your most used consoles in OnCore.
   2. To request access to these resources, please contact the OnCore CTMS Training Specialist, Brianna Wisniewski, brianna.wisniewski@mssm.edu.
2. OnCore CTMS Training Manual
   1. View and save the OnCore CTMS Training Manual for Non-Cancer Related Research to familiarize yourself with the processes on how data is entered into the system.

If you have any questions or are actively using OnCore CTMS and have a question, please submit a ticket using the OnCore Service Desk.

Thank you.
The OnCore Implementation Team