Clinical Research Informatics
The Clinical Research Informatics team supports MICHR's mission to enable and enhance clinical and translational research by providing cutting-edge informatics software and services.
The Clinical Research Informatics team is composed of three units:
- Business Systems Implementation
- Software Development
- Technical Services
Together, we develop, enhance, and support multiple, clinical research IT applications. The team is responsible for a number of initiatives that have the potential to transform U-M’s clinical and translational research mission: REDCap, OpenClinica Enterprise, UMClinicalStudies.org, TATUM, and the Research Participant Scheduling Portal.
We collaborate with several informatics and IT service units to provide federated clinical research service capabilities. They include the Medical School Information Services Research IT Program, the Center for Computational Medicine and Biology, Medical Center Information Technology, Cancer Center Informatics, the Cancer Center Clinical Trials Office, and Information and Technology Services.
Major vendor or open source applications that we support
V-OC provides web-based electronic data capture and clinical data management that is validated and compliant with regulatory requirements and other standards. 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 provides secure, web-based electronic data capture and clinical data management. Mi-OC is the same software as OpenClinica Enterprise V-OC, but allows U-M researchers and study teams to build and manage their own clinical research study databases.
REDCap is a secure, web-based application designed to support electronic data capture for clinical research studies. REDCap offers:
- An intuitive interface for data entry (with data validation)
- Audit trails for tracking data manipulation and export procedures
- Automated export procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R)
- Procedures for importing data from external sources
- Advanced features, such as branching logic and calculated fields within electronic forms
Click here to download IRB boilerplate language for REDCap.
Velos eResearch is a commercially-developed web-based clinical trial management system that allows researchers to design protocols, track consents, coordinate schedules, and collect and manage patient, financial, and study data.
Major applications that we developed
UMClinicalStudies.org helps match volunteers interested in participating in clinical research with investigators and study teams in need of study participants. The site includes a study database, information on clinical research for the public, multicultural research pages, a public search tool, information for study teams, and a HIPAA and IRB compliant volunteer registry.
The PSP was designed to facilitate research participant scheduling and administrative workflow at MCRU (MICHR Clinical Research Unit). Using the portal, investigators are able to submit their scheduling requests online to MCRU staff without going through the hassle of phone/email or fax traffic. MCRU staff is able to see all requests on a dashboard with all relevant information validated through online form submission. Once the visit is approved by MCRU staff, a digital logbook entry is automatically created for each prospective study participant visit. At the time of the actual visit, MCRU staff is able to enter all research visit information to a single data repository using the system. The PSP also allows advanced administrative reports to be generated in a faster and more reliable manner.
TATUM is a secure, interactive web-based system used for centralized patient treatment assignment. It provides a centralized location and process for multisite studies to manage randomized subject treatment groups. TATUM brings together the randomization elements generated by a statistician for a specific clinical trial and enables study team members to retrieve and assign a participant’s treatment arm electronically. It replaces randomization envelopes, tracks progress of the study, and provides documentation of study treatment assignments. TATUM was developed by the MICHR Clinical Research Informatics team and is available to University of Michigan researchers as a tool supporting U-M-sponsored clinical trials. For more information about TATUM, click HERE.
- Customer support available 8:00 a.m. - 5:00 p.m. Monday - Friday
- Vendor management for version releases and upgrades of the application
- Timely communication of system downtime or other critical issues
- Escalation and triage of support requests, as appropriate
- Request Customer Support here:[ APPLICATION SUPPORT REQUEST ]
Use the link above to submit a service request to MICHR Clinical Research Informatics customer support via a web ticket. For service requests requiring the inclusion of an attachment (i.e., account request forms, screen shots, etc.), please send an email directly to email@example.com with the attachment included in your email. (The web ticket does not permit the inclusion of attachments.)
For more information about the Clinical Research Informatics team, or additional information about the applications that we support, please email us at: firstname.lastname@example.org or contact:
Clinical Research Informatics