Clinical Research Informatics Core (CRIC)
Mission
The Clinical Research Informatics Core (CRIC) supports the Medical School Information Systems Research IT Program to improve the quality and quantity of U-M clinical research by providing cutting-edge informatics software and services.
Initiatives
CRIC is composed of three teams:
- Business Systems Implementation
- Software Development
- Technical Services
Together, these teams develop, enhance, and support multiple, clinical research IT applications. CRIC 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, Research Participant Scheduling Portal, and Freezerworks.
Partners
CRIC partners with several informatics and IT service units to provide federated, well-functioning clinical research and service capabilities. They include 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.
Other internal collaborations include the UMHS Compliance Office, U-M Centers and Clinical Departments, and MICHR.
V-OC (Validated) Enterprise Edition is a secure, web-based, clinical research software system for Electronic Data Capture (EDC) and Clinical Data Management (CDM). It offers an easy-to-use, intuitive user interface accessible via any web browser. It is the first validated clinical research system at the University of Michigan which is maintained as a 21 CFR Part 11 compliant system. The system has also been audited by the Office of Compliance for the FISMA-NIST Regulations, which are required for federal contracts. V-OC is recommended for clinical trials that may utilize federal contracts, industry sponsors, or will be submitted to the FDA.
V-OC is available to U-M researchers who are funded to utilize MICHR or SABER data management professional services for building clinical study databases.
Mi-OC Enterprise Edition, a secure, web-based clinical trial software platform for Electronic Data Capture (EDC) and Clinical Data Management (CDM), is now available to U-M researchers and study teams to build and manage their own clinical research study databases. Clinical trial data may be captured electronically at its source, or on paper forms and later transcribed into the EDC system. It offers an easy-to-use, intuitive user interface accessible via any web browser. Since its first release in 2005, it has become one of the world’s most widely adopted clinical trial software technologies powering research in over 100 countries around the world and in studies involving 10 to 10,000 study participants in all phases of clinical trials.
REDCap is a secure, web-based application designed to support electronic data capture for clinical research studies. REDCap provides:
- 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; and
- Advanced features, such as branching logic and calculated fields within electronic forms.
REDCap was initially developed and deployed at Vanderbilt University, and now has collaborative support from a wide consortium of domestic and international partners.
REDCap was selected by the Michigan Institute for Clinical & Health Research (MICHR) to offer a user-friendly, cost-effective alternative for researchers as well as provide a secure application to promote HIPAA compliance.
Velos eResearch is a clinical research data management application that allows researchers to efficiently design protocols, track consents, coordinate schedules, and collect and manage data. It uses cutting-edge web technology so research can be conducted in the clinic, the home, and the community. Built-in protections encourage adoption of best practices while enforcing regulatory compliance. Velos eResearch is a commercially-developed, regulatory-compliant, web-based system for managing clinical research. The university has partnered with Velos, adapting the system to the Health System and university needs and adding capabilities crucial to our investigators. CRIC facilitates and moderates local and international Velos user communities to share expertise and knowledge with use of the Velos application.
For questions about Velos, please contact velos-info@umich.edu
To answer the need for a central electronic location for clinical research at the University of Michigan, MICHR developed UMClinicalStudies. The UMClinicalStudies website began as a tool to help match volunteers interested in participating in clinical research with investigators and study teams in need of recruiting volunteers, and was designed to provide a single gateway for clinical research. The site consists of several pieces - 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 registry. The UMClinicalStudies Registry was released in January 2007, and consists of a database that allows patients or community members to sign up for a single study or the general registry. UMClinicalStudies Community Information & Education Sections contain a mini-tutorial about clinical research, pages focused on diversity and multicultural research participation, and a health glossary containing links to specific health conditions or preventative health information.
Prior to deployment of the MCRU Research Participant Scheduling Portal, MCRU (Michigan Clinical Research Unit) used hospital patient scheduling systems for admitting research patients to various MCRU sites after investigators submitted their scheduling requests through phone/fax or e-mail. Research patient visit specific information and scheduling requests were still being collected and stored using paper and pen, resulting in human errors and data discrepancies. The PSP was designed to facilitate research patient scheduling and administrative workflow at MCRU. 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 patient visit. At the time of actual visit, MCRU staff is able to enter all research visit relevant information to a single data repository using the system which also allows advanced administrative reports to be generated in a faster and more reliable manner. For more information, please contact MICHR Support.
i2b2 (Informatics for Integrating Biology & the Bedside) enables researchers to more efficiently identify potential research subjects for clinical trials. The purpose of UMi2b2 Cohort is to provide faculty and research staff with a self-serve query tool that provides the ability to quickly perform cohort identification and patient set analysis for potential clinical research studies via access to the UMi2b2 Cohort Data Mart. The Data Mart is loaded with de-identified patient data from the U-M Health System's clinical data sources. The UMi2b2 Cohort tool performs real-time queries and provides the ability to search for specific characteristics of this data, individually or jointly, with a simple drag & drop query mechanism. See the UMi2b2 Cohort home page for more information.
BioDBx is an internally developed electronic data capture system that provides comprehensive clinical data management, data capture and storage, protocol procedural tracking, inventory management, specimen management, and subject data entry portal capability. It is scaled to assist both the beginning scientist as well as the multi-site data coordination center and includes reporting and data extraction features. BioDBX is currently being phased out for future protocols (OpenClinica and REDCap will be used in lieu of BioDBX).
Major applications developed By CRIC:
BioDBx
UMClinicalStudies.org
MCRU Scheduling Portal
Customer support of our applications is provided by members from across the entire CRIC team and comprises:
- Customer Support available 8:00 a.m. - 5:00 p.m. Monday - Friday
- Provide and/or coordinate training sessions
- Database migrations
- Vendor management for version releases and upgrades of the application
- Communication of system down-time or critical issues in a timely manner through email and/or service web page
- Escalation and triage of support requests, as appropriate; including security issues
- Application integrations
- Collaboration and partnering with other support units (e.g. MCIT, MSIS) to troubleshoot support problems when needed
Request MICHR CRIC Customer Support here:
[ APPLICATION SUPPORT REQUEST ]
Use the link above to submit a service request to MICHR CRIC 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 michr-support@umich.edu with the attachment included in your email. (The web ticket does not permit the inclusion of attachments.)
Contact:
Jim Maszatics
Clinical Research Informatics Core (CRIC) Manager
Phone: 734.998.7215