CRISPI Expands Enterprise REDCap Services to Strengthen Clinical Research at NIH

New capabilities, a growing resource repository, and a partnership with the creators of REDCap are expanding the support available to NIH research teams.

Clinical research at NIH is becoming increasingly data-intensive, creating a growing need for reliable infrastructure that can support how research data are collected, managed, and used. Through its Clinical Research Informatics Supporting Principal Investigators (CRISPI) initiative, NIH is developing enterprise clinical research informatics services that connect researchers with modern, secure, and increasingly interoperable tools. At the center of this effort is CRISPI REDCap, a centrally managed service that provides NIH researchers with an enterprise environment for collecting and managing clinical research data.¹

CRISPI REDCap combines the REDCap platform with dedicated expertise, training, technical support, and a growing collection of resources designed to help study teams successfully develop and manage their projects.

A Centralized REDCap Service for NIH Researchers

REDCap, or Research Electronic Data Capture, is widely used by clinical researchers to build databases, surveys, electronic case report forms, and other data-collection tools. The platform was developed at Vanderbilt University Medical Center (VUMC) and has become an integral part of clinical research data collection worldwide.²

CRISPI provides a centrally managed REDCap service for the NIH Intramural Research Program, including hosting, administration, maintenance, security monitoring, backups, user management, training, and technical support.¹

For study teams, this model provides access to a supported research platform without requiring individual groups to manage the underlying infrastructure themselves.

Centralized management also creates an opportunity to promote consistency in how research data are collected and managed across the NIH Intramural Research Program.

A Unique Connection to the Creators of Redcap

A distinguishing feature of CRISPI REDCap is its partnership with Vanderbilt University Medical Center, the organization that created REDCap.

CRISPI participates in the REDCap Consortium and works with VUMC on REDCap-related capabilities and best practices.¹ The REDCap Consortium was established in 2006 and has grown into an international community of institutions using and contributing to the REDCap ecosystem.²

For NIH researchers, this relationship provides a direct connection to the organization behind the platform and to the broader community that supports its continued development.

The partnership also creates opportunities for CRISPI to stay connected to emerging REDCap capabilities and approaches as the platform evolves.

Expanding Resources for Study Teams

The technology is only one part of the CRISPI REDCap service. CRISPI is also building an extensive repository of resources to help NIH study teams navigate the development and management of their REDCap projects.

The repository is being designed to bring together educational materials, training resources, guidance, templates, best practices, and other practical tools. These resources will support teams at different stages of project planning and database design through data collection, quality assurance, and ongoing study management.

CRISPI also provides training and consultation to help research teams make effective use of REDCap and its capabilities.¹

By bringing these materials together in one place, CRISPI is creating a shared knowledge base that can benefit study teams across the NIH Intramural Research Program.

Preparing for 21 CFR Part 11 in 2027

Another significant development on the CRISPI REDCap roadmap is the planned introduction of capabilities supporting applicable 21 CFR Part 11 workflows in 2027.

What is 21 CFR Part 11?

The FDA's 21 CFR Part 11 regulation establishes requirements for electronic records and electronic signatures in certain FDA-regulated activities. The regulation includes controls intended to help ensure that applicable electronic records and signatures are trustworthy, reliable, and maintain their integrity.

For research teams conducting applicable regulated activities, these requirements can influence how electronic records are created, maintained, accessed, and documented.

CRISPI Currently Anticipates These Capabilities to Become Available in 2027

The planned enhancement will add another important capability to the enterprise REDCap service and provide additional support for study teams whose research requires applicable regulatory controls.

Connecting Research Data Across the Enterprise

CRISPI REDCap is also part of a larger effort to create a more connected clinical research environment at NIH.

CRISPI's broader strategy includes interoperability, standardized data approaches, secure data integration, and technologies that can help research information more effectively across systems.¹

The initiative is developing and supporting additional capabilities, including a Clinical Data Warehouse (CDW) and Clinical Research Dashboard (CRD), while also exploring artificial intelligence and other advanced technologies for clinical research.³

Within this broader ecosystem, REDCap serves an important role in the collection and management of structured research data.

CRISPI is also working to encourage the use of NIH Common Data Elements and other standardized approaches that can promote greater consistency across ICs and make research data more useful for downstream analysis and integration.³

Building the Infrastructure for the Future

Together, these efforts are giving NIH study teams access to a more comprehensive research environment—one that combines enterprise REDCap services with specialized expertise, shared resources, and a path toward supporting evolving regulatory requirements.

As the program grows, CRISPI is helping NIH researchers navigate increasingly complex data and research workflows while reducing the technology burden on individual study teams.

References

1. NIH Office of Intramural Research - CRISPI REDCap
2. Vanderbilt University Medical Center / REDCap Consortium - About REDCap
3. NIH Office of Intramural Research - CRISPI Programs and Initiatives