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Project Overview

Investigators and research staff face many challenges in conducting research. Limited resources, ever-changing regulatory requirements and the sheer volume of research conducted at Yale create barriers that stand in the way of accurate and efficient research. Implementing an integrated, enterprise-wide system for managing research provides benefits that affect many aspects of clinical and translational research:

Protocol & Subject Life Cycle Management:

The foundation of OnCore clinical research management, this module facilitates and provides the capabilities to set-up and activate studies, manage committees, verify subject eligibility, register subjects, monitor accrual, and report on studies.

Subject Safety Management:

Centrally controls safety monitoring activities with automated notifications within the protocol context or across all protocols. Notifications are based on key regulatory and safety functions including AE and SAE tracking, Outside Safety Report tracking, and IRB reporting.

Protocol & Subject Calendar Management:

Calendars maintain study parameters including treatment administration, evaluations, and data collection schedules. Subject-specific calendars are automatically generated to provide subject visit tracking which directly drives financials management functionality to help ensure accurate and timely billing.

Study Financials Management:

Manages financials for the life cycle of a protocol including budget estimation, standard of care versus research charge delineation, milestone-based payment terms, automated invoicing rules, invoice creation, and payment reconciliation. This module also includes an enterprise charge master.

Electronic Data Capture and Data Management (EDC and CDM):

Provides flexible capabilities for the design, utilization, monitoring, and export of electronic case report forms (eCRFs) and the data they contain. This module gives granular control over clinical data and monitoring activities across the entire research center in support of investigator initiated trials.

Paperless Committee Management with ePRMS:

An electronic system for submitting, tracking, reviewing, revising, and approving clinical trials by a scientific review committee. The on-line submission feature offers immediate access to electronic protocol documents eliminating the need to track, copy, and collate multiple binders for reviewers.

Study Information Portal:

Supports community outreach activities by providing up-to-date protocol information to the general public and outside referring physicians. A dynamic web page tied directly to the OnCore database, this module allows users to search and view select protocol information by criteria such as body site, and treatment type.

Custom Reporting Technology:

Augmenting the rich collection of standard reports, institution specific custom reports are available via integration with the third party report engine technology, JasperReports. Leveraging the built-in access and security controls maintained by the OnCore platform, reports can be produced as needed in a variety of file formats.

Subject ePayments:

Streamlines billing and payment workflow by linking OnCore with Bank of America. This creates a process with no duplication of effort in multiple systems and greatly improves budgeting and financial management by allowing for easy payment tracking.

Coverage Analysis:

Designed to support best practices, the Coverage Analysis Console in OnCore supports CRB compliance by providing the ability to store and report information for determining if a protocol meets requirements for insurance reimbursements. The console also defines billing designations upon protocol creation at the procedure or visit level, and tracks the rationale behind the designations.

Task Management:

Improves workflow visibility by allowing staff to see assigned tasks on a configurable task list. Standard milestones allow task lists to be linked together, which allows for specific tasks to be automatically triggered by events across different lists. Administrative privileges allow management staff to view detailed information for all tasks within a protocol.