REDCap or Research Electronic Data Capture is a secure web-based application developed by Vanderbilt University. Generally, it is used in building, collecting, and managing online surveys for clinical research and databases.  

A group of clinical researchers came together in 2004 with the vision for a secure data collection tool.  The need was for the software (tool) to be HIPAA compliant as well as a user-friendly web-based interface.  This unfolded into the creation of the first version of REDCap. Since then, REDCap has undergone many improvements to ensure compliance with industry regulations.

What is REDCap used for?

These ideals created easy-to-use software that required no previous knowledge or experience, and the data could be accessed from any browser on any device. This meant that the researchers could operate the software wherever and whenever required without any third-party involvement. The software is fully customizable, and you are in total control of shaping the application to meet your business needs. The simple installation and operation of the system eliminate the need for a complex team of software developers and engineers.

This intuitive and economic design allowed Vanderbilt to safely and reliably support an increasing number of research studies and surveys through the REDCap application.

The team actively and consistently provides support and feedback to continuously improve the system while keeping its easy-to-use policy in check. Researchers globally have appreciated the software’s functionality, and how it improves their research. Processes like project setup checklists, multi-language compatibility, and a shared library of pre-built instruments have provided invaluable support to their research efforts.  

A vast network such as this requires set guidelines to operate compliantly. Regulations require REDCap to operate at required and set standards, among these are GCP (Good Clinical Practices) regulations/ guidance from the FDA.  Information on these can be found in the following:

• FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, May 2007
• FDA Information Sheet: Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors, July 2014
• Use of Electronic Informed Consent Questions and Answers, Guidance for Institutional Review Boards, Investigators, and Sponsors, December 2016
• FDA 21 GCP CPGM 7348.810, “Sponsors, Contract Research Organizations and Monitors”,  April 2017.