A Clinical Trials Management System (CTMS) is a software system designed to help principal investigators, study coordinators, and other faculty and staff track and report on nearly every aspect of a clinical trial. Paper-based processes are replaced with electronic processes, and data is aggregated for use in the CTMS, as well as potentially exported and interfaced for use in external systems such as a data warehouses and the electronic medical record.Penn Medicine is extending an existing CTMS, in use for over seven years in the Abramson Cancer Center, called Velos eResearch. The benefits of this centralized Clinical Trials Management System are improved regulatory compliance, study data aggregation, visibility into study status and study progress, and financial oversight. Expansion to encompass the entire research enterprise is underway, and adoption of the system is currently planned to begin in early 2017. Once fully adopted, the system will house an estimated 2,000 clinical trials. The Penn CTMS will have interfaces to the PennChart electronic medical record, such that study, patient, and demographic data will remain current and accurate in both systems.
About the Enterprise Penn CTMS Project
The Penn CTMS is a long-term effort to evolve how clinical research is conducted. The project has multiple phases, with the first phase expected to last through the end of 2017. Phase 1 is focused on providing a tool that study coordinators and study teams can use to better manage their studies. The first phase will deliver the following goals:
- A single system to track all PSOM / UPHS human clinical research studies
- One system to track patient enrollment and adverse events
- Integration with PennChart for patient registration data (e.g. names, addresses) to reduce redundant data entry
- For studies that use PennChart , the ability to create the PennChart study record automatically through Penn CTMS
- Synchronizing patient enrollment statuses between PennChart and Penn CTMS, so there is one consistent source of enrollment data
- Creating the patients’ calendar of activities based on the protocol, to track the patient’s activities on the study
In addition, training and user access are being reviewed in phase 1 to improve operations in order to expand support from the ACC to the entire enterprise. Later phases will focus on additional benefits, such as using Penn CTMS to manage the detailed study budgets, creating and tracking invoices, and improving workflow capabilities. There may also be additional integrations with other systems as Penn CTMS becomes a key hub of clinical research activity.
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