Case report forms and surveys are critical to pilot studies and clinical trials. The Weill Cornell Medicine’s Clinical & Translational Science Center (WCM CTSC) offers investigators access to Research Electronic Data Capture (REDCap), a web-based application supported by a consortium of over 6,000 institutions led by Vanderbilt University.
Using REDCap, an investigator can build case report forms and surveys using a point-and-click interface and then collect data to support single and multi-institutional studies. In contrast to tools like Microsoft Excel and Access, REDCap stores data on a secure server that is regularly backed up. Use of REDCap can improve quality and reduce time of data collection.
Offered as a premium service, SUPER REDCap enables pre-population of case report forms with data from electronic health record (EHR) and research systems. SUPER REDCap, which leverages the REDCap Dynamic Data Pull (DDP) plugin, provides an adjudication process whereby users can approve all incoming data from a source system (e.g. Epic) before saving it in a case report form. For example, a user can select a particular blood glucose value from a list of several available in the EHR to save to REDCap. SUPER REDCap is optimized for pre-populating one-time data such as patient demographics as well as data collected over time such as laboratory results and vital signs.
REDCap is available free of charge, but SUPER REDCap and other projects with sophisticated needs may require financial support from investigators. Although REDCap is capable of 21 CFR Part 11 compliance, REDCap is not currently validated for this purpose at WCM. For researchers in need of a 21 CFR Part 11-compliant solution, REDCap Cloud is offered as a premium service.