Study entry service
Save time and start up your study more quickly. We can help by doing the following within the OnCore clinical trial management system (CTMS):
- Entering studies or protocols, ensuring required fields have been completed.
- Entering IRB review information.
- Coordinating the building of study calendars with CTSI’s Clinical Trial Financial Services (CTFS) team.
- Ensuring the study is ready for research participant management, where applicable.
- Maintaining summary accrual data through the life of the study, where applicable.
- Free service
Role of the study team
- Provide access to the study in the IRB’s ETHOS system.
- Be available if additional information is needed.
- Enter individual research participant data upon study activation (unless summary accrual is sufficient).
Electronic Data Capture (EDC) Forms Building
- Centralized system for data collection, management, and compliance through the use of electronic case report forms (eCRF)
- 21 CFR Part 11 compliance
- Form creation $63/hour
- Admin/OnCore team sets up
- Contact [email protected] to get started
Most services are available at no cost to University of Minnesota study teams.
- Support, training, quality assurance, and reporting
- Customized application and reporting services, when there is benefit to the entire University clinical research enterprise
- Implementation for external or non-University groups and other areas out the scope of the original OnCore implementation (hourly rate applies)