The REDCap Revolution: How a Clinical Data Management Tool Empowered Global Research Communities

Twenty years ago, handling clinical data was a tedious, unorganized process—until REDCap, a “big dumb container,” put in seamless guardrails.

Written byElizabeth Shuert and Kevin Johnson, MD, MS
| 9 min read
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In the early 2000s, Paul Harris, a research informatics faculty member and bioengineer at Vanderbilt University Medical Center, noticed a pressing problem. While working with research teams, he found that many of them used Microsoft Excel and SurveyMonkey tools to handle their project data, which usually included patients’ sensitive personal and health information. Although the HIPAA Security Rule, which mandated safeguarding these data, wasn’t applied to the research enterprise at the time, Harris realized that these tools were grossly inadequate for handling clinical data.

Greater data protections were inevitable and, in Harris’ opinion, a good thing. “If we’re talking about my mom’s data,” Harris recalled thinking, “I’d really rather we do this right.” He envisioned a secure, user-friendly platform allowing scientists to manage their data efficiently while complying with stringent regulatory requirements.

Fueled by this need, Harris developed Research Electronic Data Capture (REDCap). What began as a localized solution to data management at Vanderbilt University evolved into a global standard over the years, enabling data collection for more than 2.4 million research projects across over 7,800 academic, non-profit, and government organizations. Harris’ “big dumb container,” as he jokingly calls it, changed the face of modern-day clinical research.

The Metadata Moonshot

Headshot of Paul Harris, creator of REDCap and Vice President of Research Informatics at Vanderbilt University Medical Center

Paul Harris’s REDCap injected more standardization, privacy protection, and ease-of-use into the research process. So far, it has supported over 2.4 million projects across the globe.

Joe Howell, 2021

Harris’ career began in aerospace engineering, working on the Mars mission. He left in search of work that could result in a more tangible human impact, enrolling in a biomedical engineering doctoral program at Vanderbilt University in the 1990s. At first, he thought designing prosthetic arms would satisfy his hunger to solve meaningful problems. But instead, he found greater satisfaction in supporting the diverse research efforts of his colleagues—specifically, by creating digital systems to help them manage and advance their work.

David Robertson, a physician-researcher at Vanderbilt University and Harris’ mentor once told him, "At Vanderbilt, there are a lot of smart people. I think what you should do is spend time with those smart people. Figure out what problems they have and then solve those problems." Harris did just that, joining the faculty at Vanderbilt University in 1999.

The HIPAA Security Rule had been proposed just the year before. The act dealt specifically with the rise of digital protected health information, or ePHI, and stipulated several safeguards that were difficult to account for with current database technology, including device security, frequent data back-ups, data encryption, and audit trails.

Anticipating that the Security Rule would inspire increases in federal regulation, Harris began strategizing a novel approach for “collecting, storing, and disseminating project-specific clinical and translational research data” by asking researchers to describe the data’s features with general descriptors such as “record” and “date,” also known as metadata.1 He theorized, “If we could abstract away the details about your data but somehow be able to provide that in a computer format, like a spreadsheet, then we could build one set of features and functions… I could create that one time for everyone.”

By leveraging metadata, REDCap could meet various data collection needs and could be repurposed across disciplines. REDCap relied on the participation of the research teams. In practice, the approach required them to first think through their project in terms of the specific types of data and how they interrelate without requiring them to perform the coding work of a biostatistician.

In 2004, the first version of REDCap was released. Over time, it evolved to include a library of features, including easy data entry using a built-in survey tool, shareable project documents with auditing support, and data analysis functions which integrated common statistical packages.

Harris, who recalled playing the role of a “social engineer,” said, “What I found was that it was a really easy way to bring the whole research team together.” REDCap’s intuitive interface placed the power of expertise back in the hands of researchers, teaching them to become their own informaticians and giving them more power over the data they collected.

A Grassroots Movement for Improved Clinical Data Management

Although he was confident his work filled a known gap in clinical research, Harris’ first attempt to publish about REDCap was rejected from the Journal of the American Medical Informatics Association. He collaborated with colleagues to revise the paper, only to have it rejected twice more.

Meanwhile, REDCap was going viral, becoming rapidly adopted at Vanderbilt University. In 2005, Harris met Nathanial González, a software developer at the University of Puerto Rico (UPR) who became his first external collaborator on the programming effort. Convinced from its conception that REDCap should be free and accessible to anyone who requested it, Harris and González began promoting the program across the country. As Harris fanned the flames, REDCap spawned grassroots movements at other institutions and drew others to become part of its collective.

"[REDCap] was built on trust, and it was built on volunteerism," Harris said. UPR became the first member of a multi-institutional collaboration that would later be labeled by its members as the REDCap Consortium.2

Rob Taylor, REDCap lead developer standing and chatting with Paul Harris at REDCapCon in September, 2023 in Seattle, Washington

Rob Taylor, REDCap lead developer (left), and Paul Harris (right) at REDCapCon in September 2023 in Seattle, Washington

REDCapCon, 2023

The consortium was not just focused on strengthening REDCap's architecture; it also acted as a generative support network for REDCap administrators. User IDs became names as people submitted questions to an online help forum and contributed their own work to a shared library of data collection instruments and templates. Soon, a community sprouted. “This camaraderie is something that’s really special and unique,” Harris reflected.

By 2009, when the first academic article introducing REDCap was finally published in the Journal of Biomedical Informatics, the REDCap Consortium included about 50 institutions, including international partners.1 2009 was also the inaugural year for what would later be known as REDCapCon. Names then became faces as REDCap administrators attended REDCapCon in Nashville to discuss novel problems that could be solved using REDCap's strong foundation.

REDCap, which was now a product and service, could be shared widely because of the associated support system. Testaments to REDCap's accessibility and usability cropped up everywhere; it could even be installed on a Nintendo Wii.

REDCap Reimagines Healthcare in South Africa

In 2012, Michael Klipin, a general surgeon from the University of the Witwatersrand, Johannesburg (Wits), came into contact with REDCap and was immediately smitten with the technology. "I'd been banging my head against a brick wall with Excel [key] stroke access,” he said. “When I saw REDCap, I realized how easy it was to use as a clinician who's IT-illiterate...if I could use it, everyone could use it."

As a member of the Wits Faculty of Health Sciences, Klipin experienced a medical terrain vastly different from that of the United States. South Africa's wealth inequality had worsened since the end of apartheid in 1994. The disparity extended to healthcare systems, where populations who could afford it paid for private hospital services, while the vast majority of South Africans sought care in public hospitals without advanced health information technologies.

At Wits, researchers used paper records or spreadsheets for data management, resulting in the same fragmented data, labor-intensive record keeping, and security concerns that Harris noted in the US. This lack of data standardization and software expertise limited interoperability and secondary data analysis. In other words, research rarely translated to patient care.

REDCap presented an opportunity to systematize research data collection in an underresourced, often chaotic healthcare setting.3 To implement Harris' creation, though, Wits had to overcome unique obstacles. The biggest hurdle was psychological: How could Klipin encourage new users to adopt an unknown foreign technology and pivot away from methods they knew? The answer lay in one individual, the first of many of what Klipin calls "clinical champions," Irma Maré.

Maré was a previous research assistant who volunteered to become the first REDCap administrator at Wits. To encourage uptake, Maré hosted workshops to walk end-users through the process of creating a project database. "You're all here today," she remembered telling her students, "because you want to learn this program. And I have really good news for you: It's designed just for people like you. I'm going to take you through the moves today. You're not going to remember it, but that's okay. You're going to remember that you could do it."

With Maré’s workshops demonstrating REDCap’s accessibility, Wits faculty began adopting it at an exponential rate. In August 2013, one year after REDCap was installed, 140 users had registered within the Wits health sciences department alone.4 By 2021, the number of active users had increased 25-fold to 3,447 active users.3 More users have since joined every year, largely due to the COVID-19 pandemic driving teams to remote applications and South Africa’s introduction of the Protection of Personal Information Act in 2020, which mandated secure applications.

One early project was neonatologist Daynia Ballot's database on very low birth weight infants. REDCap allowed her to capture data from tens of thousands of infants, which she then used to compare the quality of neonatal care in South Africa public hospitals to those of others across the world as part of the Vermont Oxford Network. The original database also became a resource for upcoming pediatricians conducting research as part of their training.

A smiling research nurse enters data into REDCap on a tablet while sitting outside the surgical ward of Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg, South Africa.

REDCap is easy to use even for those without a high level of tech literacy. This photo was taken outside of the surgical ward of Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg, South Africa, featuring a research nurse confidently inputting data into REDCap on her tablet.

Irma Maré, 2017

One of REDCap’s most significant adaptations for global health came in response to a common technological barrier in lower-resourced countries: inconsistent internet access. In many parts of Africa, intermittent connectivity made web-based data entry unreliable. To address this, Harris and his team developed the REDCap Mobile Application in 2014, allowing researchers to collect data offline and synchronize when a connection became available.5 This innovation expanded REDCap’s reach, enabling field studies on HIV testing, maternal health, and infectious diseases in remote communities.6

The surge in REDCap’s visibility within the research sphere spawned questions about how it could help clinicians without access to electronic health records (EHRs). After its implementation at Wits, REDCap eventually catalyzed efforts at public hospitals lacking EHR infrastructure—hospitals like Chris Hani Baragwanath, the largest hospital in Africa and one of the busiest trauma units in the world—to create electronic copies of patient discharge summaries. The availability of an electronic discharge summary helped aggregate digital data for potential research and ensured better continuity of care.

While these use cases demonstrate REDCap's generalizability, they also illustrate Harris' loyalty to his founding principles: REDCap should always be basic, free, and serviceable. “I wanted to change the world by giving it away,” Harris said.

This democratic access to research technology springboarded new inquiries across the world. The consortium, which now includes users from 160 countries, birthed divisions dedicated to the needs of specific communities, including REDCapCon Hispano, which represents Spanish-speakers in 17 countries, and the REDCap Africa Consortium, which brings together administrators from across the continent to immerse themselves in all things REDCap and raise up informaticians in areas where informatics training is rare.

Unlocking the Patient Record Data Vault

As REDCap grew, so did the demand for seamless integration with EHRs. In 2017, when Vanderbilt University adopted Epic as its hospital EHR system, it became clear that linking Epic to REDCap could allow researchers to capitalize on the wealth of data stored there. Traditionally, extracting patient data for research involved manual data entry or complex database queries—processes prone to error and inefficiency. REDCap’s interoperability with EHRs eliminated these redundancies, providing researchers with real-time access to structured clinical data.

The breakthrough came with the introduction of Clinical Data Interoperability Services (CDIS), which leveraged the Fast Healthcare Interoperability Resources (FHIR) standard.7 By providing a syntactic template for how EHR vendors should store their data, the FHIR standard allowed data to be easily exchanged across platforms. Once enabled, CDIS could pull patient data directly into REDCap, significantly accelerating data analysis and study recruitment in environments where around 80 percent of clinical trials traditionally fail to meet their enrollment deadlines.

Gordon Bernard, who acted as the director of Vanderbilt Institute of Clinical and Translational Research up until 2023, spent his career researching ways to improve care for critically ill patients. In his recent study of patients on ventilators, Bernard was able to analyze over eight million individual data points regarding blood-oxygen saturation over time, thanks to REDCap's interoperability with Vanderbilt University’s EHR.8 "That’s a revolutionary thing,” he said of REDCap’s impact on clinical care. " I know of no parallel."

Harris’ technology has succeeded in all the ways he intended 21 years ago: it has become the “triple threat,” as it is known in medicine, directly impacting the three areas of clinical care, research, and science education.

"I tend to love global health," he remarked on one of his motivations for creating REDCap. "We've been given so much, and we really need to figure out ways to give back. I think that has been part of my guiding light, that philosophy: To each has been given much, much is required.”

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Meet the Author

  • Photo of Elizabeth Shuert against a green background. She wears a black top and beige blazer.

    Ellie Shuert is a freelance journalist and podcast producer based in Philadelphia. She produces Informatics in the Round, a biomedical informatics podcast, and holds a bachelor’s degree in English and linguistics from the University of Pennsylvania. She enjoys covering healthcare, technology, and the people driving innovative social enterprises. In her free time, she experiments with French cooking techniques—often with guidance from YouTube.

    View Full Profile
  • Kevin Johnson looks at the camera. He is wearing a gray shirt and blazer against a green background.

    Kevin Johnson, MD, MS, is an internationally known biomedical informatics leader at the University of Pennsylvania, where he advances AI-driven clinical care. He developed, deployed and evaluated foundational health IT systems at Johns Hopkins and Vanderbilt. His lab explores AI’s role in reimagining patient care. An elected member of multiple academies, Johnson also engages the public through documentaries, a podcast, and a children's book series called, “Who, Me?”.

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