OpenClinica is a web-based clinical trial software platform for electronic data capture and clinical data management.
OpenClinica V-OC (validated) is available to U-M researchers who are funded to use MICHR and Statistical Analysis for Biostatistics and Education Research (SABER) data management professional services for building clinical study database components, typically for FDA-regulated research endeavors. Access is coordinated by data managers working with the research team. Learn more about working with MICHR data managers here.
Open Clinica Mi-OC (non-validated) is available to clinical study research teams who wish to build their own research study databases. 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.
To obtain OpenClinica Mi-OC access, you must complete a free mandatory two-day training program. The training program provides basic skills for performing the Mi-OC functions available to the data manager role, including building all study database components, enrolling patients, entering data, managing discrepancies, and performing data extracts. After successful completion of the two-day program, research staff will be eligible for a Mi-OC data management role.
If your primary role in using OpenClinica will be that of an “end-user” ( i.e., an investigator, monitor, or data entry staff), you will need to participate in a related subset of the two-day course to become eligible for an account.
OpenClinica training from MICHR is offered through the end of 2016 by contacting firstname.lastname@example.org.
Beginning January 1, 2017, role-based training can be obtained for a cost from OpenClinica. Sign up for super-user or end-user training here. (Please remember to include training costs in your grant application.)