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 utilized the following data management systems: REDCap for single/limited-site and OpenClinica or Medidata Rave for multi-site clinical trials and clinical studies. These 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.
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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
ICTR REDCap (Research Electronic Data Capture) is a largely self-service, secure, web-based application used for building and managing data collection forms. REDCap provides data management functionality by allowing the development of electronic instruments and surveys to support data capture for research studies, including those that involve protected health information (PHI).
REDCap provides: 1) an intuitive interface (with optional data validation for data captured on forms and surveys); 2) audit trails for tracking data manipulation and export procedures; 3) export procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R); 4) Reporting capabilities and 5) procedures for importing data from external sources.
ICTR REDCap should not be used for studies conducted under an IND or IDE where REDCap will contain source data, electronic signatures, or be relied on to perform study activities (e.g., assess eligibility). It is currently not 21 CFR part 11 compliant. ICTR REDCap may be used as a data entry system for purposes of data analysis. We are working towards part 11 compliance in 2021 and will alert users once this is available.
Login to REDCap here: https://redcap.ictr.wisc.edu/
Request a REDCap User Account, here.
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
Medidata Rave
For most types of clinical research, especially large, complex or multi-site randomized, controlled trials (RCTs), Medidata Rave, 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. Medidata Rave also brings a powerful multi-site collaboration capability for clinical trials and other types of clinical research. Medidata Rave is fully 21 CFR Part 11 compliant, making it the ideal solution for NIH-sponsored or FDA-regulated clinical trials. This adoption of Medidata Rave 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 Medidata Rave