Definition · Plain-language
REDCap
REDCap is a secure, web-based software application designed to build and manage online databases and surveys specifically for clinical and translational research projects.
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Designed for clinical regulatory compliance
REDCap was developed at Vanderbilt University specifically to support clinical and translational research, where data security and regulatory compliance are paramount. Unlike general survey platforms, REDCap provides full audit logs that track every change made to the database, including who viewed or edited a record. It facilitates compliance with regulations like HIPAA and 21 CFR Part 11 by enforcing granular user permissions, allowing investigators to restrict access to personally identifiable information. This detailed tracking ensures that clinical trials meet FDA regulations. The software is distributed free of charge to member institutions of the REDCap Consortium, promoting collaborative, secure research across global networks.
Database and survey integration
REDCap combines the features of an online survey tool with a structured relational database. Researchers can design data collection instruments (Case Report Forms or CRFs) for internal clinical staff, while also generating public-facing or participant-directed surveys. It supports longitudinal data collection, allowing the same form to be administered across multiple visits, and includes a double-data-entry module to compare inputs from two independent data entry specialists for accuracy. This integration is essential for clinical trials, where patient history must be updated systematically across scheduled clinic visits while maintaining a unified participant record that is highly secure and structured. This relational architecture ensures that longitudinal records remain consistent and auditable throughout the clinical study lifecycle.
Data quality, piping, and offline use
The platform includes data validation tools, branching logic, and calculated fields to prevent entry errors in real time. REDCap also supports dynamic piping, which inserts a participant’s previous answers into subsequent questions. For field research in areas with unreliable internet connections, the REDCap Mobile App allows secure offline data capture on tablets or smartphones. Once a connection is re-established, the app synchronises the data back to the central institutional server. This capability is vital for epidemiologists and field researchers conducting community-based surveys in remote regions without internet access, enabling reliable data capture under difficult field conditions. This offline functionality makes it an indispensable tool for global health initiatives operating in resource-limited or geographically isolated settings.
Key facts
At a glance
- Compliance-ready: designed to support HIPAA and FDA 21 CFR Part 11 clinical regulations.
- Audit trails: logs all user actions, data modifications, and exports automatically.
- Dual function: operates both as a secure database and a participant survey tool.
- Longitudinal support: tracks participant metrics across repeating events or visits.
- Mobile app: permits secure offline data collection with automatic synchronisation.
- Consortium model: distributed via a global consortium, requiring institutional membership.
Common misconceptions
What people often get wrong
Often heard: REDCap is a free public cloud service like Google Forms.
Actually: REDCap is not a public cloud service. It is software that must be hosted on an institution’s secure servers. Access is provided to researchers through their participating consortium institution.
Often heard: REDCap is only useful for standard, single-occasion online surveys.
Actually: REDCap is a database system built for multi-stage clinical trials, patient registries, longitudinal research, and operational workflows that require secure data entry by clinical staff.
Common questions
FAQ
What is the REDCap Consortium?+
The REDCap Consortium is a global collaboration of academic, non-profit, and government institutional partners. Members share code, support each other, and host REDCap locally on their own secure computing infrastructure.
Can REDCap handle randomisation in clinical trials?+
Yes. REDCap has a dedicated Randomisation Module that helps researchers assign participants to treatment groups. It uses pre-defined randomisation allocation tables to prevent allocation bias during clinical trials.
Going deeper
