What is this service?
MICHR and Statistical Analysis for Biostatistics and Education Research (SABER) from the School of Public Health offer OpenClinica software and related services to University of Michigan research teams.
OpenClinica is a web-based clinical trial software platform for electronic data capture and clinical data management.
V-OC OpenClinica Enterprise Edition (validated):
V-OC provides web-based electronic data capture and clinical data management that is validated and compliant with regulatory requirements and has been audited by the Office of Compliance against NIST 800-53 standards developed by the National Institute of Standards and Technology. To ensure these standards are maintained, research teams must engage the professional services of MICHR data managers for database development and related data management activities. With training and authorization, U-M researchers can use OpenClinica to enter participant research data into the system, monitor it for integrity and approve content using an electronic signature. V-OC is recommended for single or multi-site clinical research projects in the following scenarios:
- Clinical trials funded through federal contracts
- Submission of research data to the Federal Drug Administration (FDA)
- Clinical trials conducted for an industry sponsor
- Clinical trials requiring programmed data edit checks and online data discrepancy resolution
- Clinical trials requiring a web-based interface for data management and monitoring activities
Mi-OC OpenClinica Enterprise Edition (non-validated):
BMi-OC is not maintained as a 21 CFR Part 11 compliant system, so it is recommended for research data that will not be used to support a new drug / device submitted to the FDA, federally contracted clinical trials, or industry-sponsored trials. Mi-OC is the same software as OpenClinica Enterprise V-OC, and is available to clinical study research teams who wish to build and manage their own research study databases.
OpenClinica demos are available here.
Who can use this service?
Principal investigators and study teams at U-M can use this service.
When should I contact MICHR about this service?
You should request access to OpenClinica soon after your study protocol has been developed.
How much does this service cost?
There is no cost to use OpenClinica.