Data Management Systems
Investigators involved in clinical research require mechanisms for collecting and managing their data with quality assurance and quality control. Building a custom data management system including electronic data capture (eDC) for each study is time consuming, expensive and a needless duplication of effort. To support the creation of coordinated and comprehensive data management systems for clinical trials and clinical studies, the Data Coordinating Center, Department of Biostatistics & Medical Informatics, University of Wisconsin School of Medicine and Public Health, has designated two data management systems: REDCap for single/limited-site and OpenClinica for multi-site clinical trials and clinical studies. These two systems were chosen to offer a wide range of services for clinical trials and clinical studies at all levels of complexity and scale, while being cost-conscientious. We have access to other data management systems if needed.
Tier 1: REDCap
The Research Electronic Data Capture (REDCap) system was developed at Vanderbilt University. Little or no cost REDCap is appropriate for trials with low to medium data collection complexity. It supports single or limited-site trials, and is available through the Institute for Clinical and Translational Research (ICTR). Use of REDCap incurs no direct cost for investigators, unless BMI builds and configures the study for investigators.
Read more about REDCap
Tier 2: OpenClinica
For most types of clinical research, especially large, complex or multi-site randomized, controlled trials (RCTs), OpenClinica, adopted in partnership with the Frontier Science and Technology Foundation, Inc.’s Amherst Office (FSTRF), provides the BMI DCC with new, strategic-level capabilities in both eDC and data management. Its scalable architecture provides regulatory compliance, sophisticated complex data management and quality assurance and control. OpenClinica also brings a powerful multi-site collaboration capability for clinical trials and other types of clinical research. OpenClinica is fully 21 CFR Part 11 compliant, making it the ideal solution for NIH-sponsored or FDA-regulated clinical trials. This adoption of OpenClinica in partnership with FSTRF positions the University of Wisconsin-Madison and the BMI well as a data coordinating center for UW-investigator initiated multi-site clinical trials.
Read more about OpenClinica