The following content may be used in your COMIRB application (Section O) if you are planning to use REDCap:
Study data will be collected and managed using REDCap (Research Electronic Data Capture). REDCap is a secure web application designed to support data capture for research studies, providing user-friendly web-based case report forms, real-time data entry validation (e.g. for data types and range checks), audit trails and a de-identified data export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). The system was developed by a multi-institutional consortium which includes University of Colorado–Denver and was initiated at Vanderbilt University. The database is hosted at the University of Colorado–Denver Development and Informatics Service Center (DISC), which will be used as a central location for data processing and management. REDCap data collection projects rely on a thorough study-specific data dictionary defined in an iterative self-documenting process by all members of the research team with planning assistance from the DISC. This iterative development and testing process results in a well-planned data collection strategy for individual studies. REDCap also includes a powerful tool for building and managing online surveys. The research team can create and design surveys in a web browser and engage potential respondents using a variety of notification methods. REDCap is flexible enough to be used for a variety of types of research and provides an intuitive user interface for database and survey design and data entry.
P.A. Harris, R. Thielke, R. Taylor, J. Payne, N. Gonzalez, J.G. Conde. Research Electronic Data Capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics, 2008
Instructions for obtaining consent using a REDCap survey:
Generally, to gain consent from individuals to participate in a study through a RedCap survey, investigators need to complete the Postcard Consent Form - Information Sheet Template and place it at the beginning of their survey, before any questions are shown, to act as the consent form and consent process for the study. Potential participants should be required to click an “I agree to participate in this study” link or button at the end of the consent form prior to being shown the survey. All consent forms, consent processes, information sheets, and data collection tools must be submitted to COMIRB and approved by COMIRB before they are used.
For studies submitted for Expedited or Full Board review, investigators must request a waiver of documentation of consent for their study. An option to request a waiver of documentation of consent is included as part of the Application for Protocol Review Form.
Please contact COMIRB directly with questions about consent documents and processes:
: Come to Office Hours : www.ucdenver.edu/comirb