OnCore CTMS (Clinical Trials Management System)
General Information About OnCore System-Wide implementation
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.
- 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.
- 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.
- Electronic data capture & data management.
- Protocol & subject life cycle management.
- Subject visit tracking.
- Research billing compliance, budgeting & invoicing.
- Effort tracking.
- Task management.
- 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
Updates About OnCore Implementation
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, firstname.lastname@example.org.
- OnCore CTMS Training Modules
- 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.
- To request access to these resources, please contact the OnCore CTMS Training Specialist, Brianna Wisniewski, email@example.com.
- OnCore CTMS Training Manual
- 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.
The OnCore Implementation Team