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.
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.
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.
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.
OnCore's inventory management functionality provides centralized control over the entire repository at an enterprise level throughout the lifecycle of the specimens and all of their derivative samples. Designed around biorepository operations, the system helps enforce key workflow parameters such as the capture of donor consent and the standardization of data entry. OnCore provides investigators and repository administrator’s permissions-based access to real-time specimen status, location, and inventory information through its web-based interface.
Balancing data entry speed and efficiency with the desire to gather sufficient data is facilitated by configurable specimen collection screens. Extensible annotations for structured data and the ability to attach pathology reports, histologic images, and other electronic documents allow the capture of more data over time to satisfy researcher's increasing data requirements.
Requisition & Distribution Management:
OnCore makes it easy to maintain control of data while providing an appropriate level of access to information for a distributed group of people. Working Lists help organize tasks by tracking specimens to be processed. The Working List feature, in conjunction with integrated barcode printing and scanning capabilities, makes reserving, labeling, checking-in, checking-out, and shipping specimens efficient and intuitive.
Correlative Study Sample Management:
In addition to comprehensive prospective banking functionality, OnCore supports the specific needs of correlative research studies with subject calendar-based tissue collection scheduling, visit-specific specimen collection, and processing configurations including laboratory processing and data collection.
Flexible Reporting Capabilities:
No data in OnCore is out of reach with three options for report creation. First, OnCore comes with a rich collection of standard reports. Second, a strong search and ad hoc reporting feature offers superb flexibility. Search results from this feature can be used to create Working Lists of specimens to be processed. Finally, institution-specific custom reports can be created via OnCore's integration with the third-party report engine technology, JasperReports. Leveraging the built-in access and security controls maintained by the OnCore platform, these reports can be loaded into the system to be produced as needed in HTML, PDF, Excel, CSV, and RTF file formats.
Registry Life Cycle Management:
This module provides the capabilities to set-up and create new registries, control staff access to registries, assign institutions to registries, and assign forms to patients, events, or cases. Additionally, this module facilitates tracking of the status of individual registries.
Electronic Data Capture and Clinical Data Management (EDC & CDM):
OnCore registries streamline data management through a simple model using cases and events. A case is an occurrence of what is being studied within a registry. For example, a case might be a myocardial infarction, pregnancy, cancer diagnosis, or new patient, depending on the focus of the registry. An event is an opportunity to collect data relevant to a case and is usually linked to one or more form. For example, an event for a registry tracking myocardial infarction outcomes might be a follow-up visit with the cardiologist or a stress test, both of which would have specific forms for data collection.
Form Design & Management:
The flexibility to define and collect any data required for a particular registry is made possible through a powerful forms engine. Forms may be specified at the case, patient, or event level. Utilizing a logical display and multiple layout options, forms have a relative consistency throughout the system which improves the quality of data collected and simplifies training. While the forms engine utilizes Common Data Elements to facilitate consistency, it also provides powerful customization features such as the ability to specify field labels and layouts to meet the individual needs of investigators.
Flexible Reporting Capabilities:
No data in OnCore is out of reach with two options for report creation. First, a strong ad hoc reporting module offers superb speed and flexibility. This module is easy to use with such features as checkboxes for selecting included fields and drag-and-drop column ordering. All data fields in a registry are available for ad hoc reporting. For more complicated reports, such as those that compile data across multiple registries, custom reports can be created via OnCore’s integration JasperReports, a third-party report engine technology. Custom reports are easily uploaded into OnCore and the results may be exported in HTML, PDF, Excel, CSV, and RTF file formats.