REDCap One of the Ways CRISPI Supports Research

Clinical research generates an enormous amount of information. From participant surveys and electronic case report forms to longitudinal study data, researchers need reliable tools to collect, organize, and manage information throughout the research process.

Supporting researchers as they navigate these data and technology needs is an important part of the work of the Clinical Research Informatics Supporting Principal Investigators (CRISPI) initiative at the National Institutes of Health (NIH). One of the ways CRISPI supports that mission is through an enterprise REDCap environment, providing researchers with a secure, flexible platform for collecting and managing research data alongside clinical research informatics expertise and dedicated support.

What Is REDCap?

REDCap, or Research Electronic Data Capture, is a secure, web-based application designed specifically to support research data collection and management. Researchers can use the platform to create electronic case report forms, surveys, study databases, and longitudinal research projects.

The platform was created at Vanderbilt University in 2004 by a team led by Paul A. Harris, Ph.D., and has since grown into a widely used research data collection platform through the REDCap Consortium. Its development was based on a simple principle: researchers should have the ability to build data collection tools that meet the specific needs of their studies.

For clinical researchers, that flexibility is particularly valuable. REDCap allows research teams to configure data collection instruments, establish validation rules, use branching logic, and collect information at multiple time points. These capabilities can help researchers establish consistent data collection processes while maintaining the flexibility required for different types of studies.

“REDCap gives researchers the ability to build a data collection environment around the needs of their study rather than forcing the study into a one-size-fits-all system,” said Melissa Foreman, CRISPI REDCap Project Manager. “Our goal through CRISPI is to make that capability easier for NIH researchers to access while providing the expertise and infrastructure needed to use REDCap effectively.”

Why REDCap Matters to Clinical Research

The quality of a research study depends heavily on the quality of the information collected during that study. Inconsistent data collection processes, manual data entry, and disconnected systems can create challenges for research teams and make it more difficult to manage information throughout a study.

REDCap helps researchers establish structured data collection workflows from the beginning of a project. Required fields, data validation, calculated fields, branching logic, and other capabilities can help teams collect information consistently and identify potential data issues during the collection process.

The platform can also support longitudinal research, allowing investigators to collect information from participants at different stages of a study. Data can then be organized and prepared for analysis using commonly available research and statistical tools.

“Good clinical research depends on having reliable data and reliable processes for collecting that data,” said Melissa Habrat, Deputy Director of Clinical Research Informatics and CRISPI Co-Lead. “REDCap provides researchers with a flexible framework for designing those processes, while our role is to help investigators understand how to use that framework effectively for their research.”

How CRISPI Supports Researchers

Providing access to REDCap is one part of CRISPI’s broader effort to help NIH investigators address the clinical research informatics needs that arise throughout the research lifecycle. Investigators may need assistance with much more than selecting a data collection platform. They may also need guidance on database design, electronic data collection workflows, user access, data management, interoperability, and other technical or operational considerations.

The CRISPI REDCap team can work with research teams during project planning and development, provide guidance on database design and electronic data collection workflows, and support training and ongoing technical needs. The centralized approach also means that investigators do not have to independently manage the underlying infrastructure required to operate a REDCap environment.

“Researchers should be able to focus on their scientific questions rather than the infrastructure required to collect their data,” Foreman said. “CRISPI takes on much of the technical and operational responsibility so investigators can concentrate on designing and conducting their research.”

REDCap is one example of how CRISPI brings clinical research informatics expertise and resources together to help investigators address the practical challenges of conducting research.

A Direct Connection to the Creators of REDCap

One of the unique advantages of CRISPI REDCap is its connection to the broader REDCap community and to Vanderbilt University Medical Center (VUMC), where REDCap was created.

CRISPI works closely with VUMC as a collaborative partner within the REDCap Consortium. This relationship gives the CRISPI team access to broader expertise, resources, technical knowledge, and community developed around REDCap since its creation.

The connection is particularly valuable because it provides a direct link between NIH researchers and the community responsible for developing and advancing the REDCap platform.

“Being part of the REDCap Consortium gives us an important connection to the people and expertise behind the platform,” said Nicholas Dobbins, Director of Clinical Research Informatics and CRISPI Co-Lead. “Our collaboration with Vanderbilt allows us to stay closely connected to REDCap developments, best practices, and emerging capabilities. That ultimately helps us bring those insights back to the NIH research community.”

The relationship also provides access to consortium resources designed to support REDCap administrators and research organizations. These resources include technical information, training opportunities, community discussions, demonstrations, and opportunities to learn from other research institutions using REDCap.

For NIH researchers, that broader community can provide an additional source of knowledge beyond the support available directly through CRISPI.

Connecting NIH Researchers to a Larger Research Community

REDCap has grown from a tool created to meet the needs of clinical researchers at Vanderbilt into a platform used by research institutions around the world.

Through the REDCap Consortium, participating organizations contribute to a larger community focused on supporting and advancing the platform. CRISPI’s participation gives NIH an opportunity to both benefit from and contribute to that community.

The connection also supports CRISPI’s broader goal of building a more connected clinical research informatics environment at NIH.

Building an Enterprise REDCap Environment

CRISPI’s approach differs from having individual research groups or organizations independently establish and maintain separate REDCap environments.

Through an enterprise model, CRISPI provides centralized hosting and platform administration along with system maintenance, security monitoring, backups, user management, and other operational services.

This approach is intended to reduce duplicated effort while establishing a consistent foundation for research data collection across the NIH Intramural Research Program.

Learn More

As CRISPI continues to expand its REDCap capabilities, the team is also working to support applicable research workflows governed by 21 CFR Part 11, including electronic records and electronic signatures. These efforts build on REDCap’s established role in helping researchers address real-world data collection challenges while advancing CRISPI’s broader goal of providing NIH investigators with the technology, expertise, and support they need throughout the research lifecycle.

“REDCap has a remarkable history of helping researchers solve real-world data collection challenges,” Foreman said. “Our opportunity at NIH is to build on that foundation and provide researchers with the technology, expertise, and support they need to move their studies forward.”

Interested in learning more about REDCap or how CRISPI can support your research? Send us a message at redcap@nih.gov. Our team can answer questions and connect you with the resources and support you need.