Basic information associated with a particular protocol is recorded including protocol type, objectives, IRB and other committee reviews, research staff names and roles, and sponsor information.
Subject information for a particular protocol is recorded including demographics, consents signed, and milestone dates for:
- On study
- On treatment
- Off treatment
- On follow-up
- Off study
Calendars maintain study parameters including treatment administration, evaluations, and data collection schedules. Subject-specific calendars are automatically generated for subject visit tracking which drives the financial management functionality.
Record AEs, SAEs, External Safety Reports and export to report to the IRB. Automatic safety notifications via email are configurable by protocol staff and/or role.
Users are assigned specific access role(s) and assigned to specific institutions and management groups in their OnCore account. Each protocol is associated with specific management groups, institutions, and staff. Taken together, this provides users with the access they require to work in OnCore on their specific protocols.
Electronic Case Report Forms (eCRFs) may be created and associated with particular subject visits in support of investigator initiated trials. eCRF data entry is easy to navigate with its status-organized tabs. For analysis, form data can be exported in MS Excel and SAS formats.
Data monitor queries are available for section and/or field level within an eCRF.
Individual biospecimens can be tracked and monitored. Reporting capabilities exist at the individual sample or the biorepository level.
Standard and custom reports are available. Additionally there are search functions that allow queries on dozens of fields. Together, these features help pull information together about clinical research trials with an ease not previously available. Powerful reporting features can serve as a data-driven means for crafting operational and staffing decisions.
Financial management includes:
- budget creation and negotiation
- standard of care versus research-related charge delineation
- milestone-based payments
- automated invoicing rules
- invoice creation
- payment reconciliation
The financial functionality also includes the potential for importing an enterprise charge master.
Staff may track their effort during the life of a protocol through integrated functionality. Staff Effort Tracking and Reporting can assist with effective budgeting and negotiating for clinical trials, establishing performance benchmarks and supporting requests for increased resources.
The Study Information Portal (SIP) supports a web-based interface for the general public to search and view protocol information in real-time and is tied directly to the OnCore database.