Cited by 51,384Research Data Management PracticesElectronic Health Records SystemsScientific Computing and Data Management

Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support

Open access
Harris, Paul A., Taylor, Robert, Thielke, Robert, Payne, Jonathon, Gonzalez, Nathaniel, Conde, Jose G.·2009·Journal of Biomedical Informatics

Abstract

Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.

Integrity signals

Registry

Crossref · 10.1016/j.jbi.2008.08.010

Cites

6 of 6 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 6 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The total number of subjects in all Vanderbilt and Meharry production-level clinical research study databases is currently 17,959.

    “The total subjects in all Vanderbilt and Meharry production-level clinical research study databases currently numbers 17,959 and demonstrates active use for the REDCap system in the clinical domain.”
    Quote in the paperNot a substantial claim
  • Premisecitation

    Buying and maintaining large commercial clinical data management systems can be too expensive.

    “The cost of purchasing and supporting major vendor solutions for clinical data management systems can be prohibitive.(8)”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [8] Zubatch M. Value of Hosted Clinical Data Environments. Bio-IT World. 4-14-2006. Ref Type: Magazine Article.

      Not checked in the free run.

  • Premisecitation

    Traditional EDC setup time for CRFs and software expense may outweigh benefits for the study in the academic research environment.

    “In these cases, traditional EDC setup time for CRFs and software expense may outweigh benefits for the study.(9)”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [9] Weber, 2005, A comparison study: paper-based versus web-based data collection and management, Appl Nurs Res source

      Not checked in the free run.

    • Rests on an assumption: The academic research environment typically has many preclinical investigator-initiated research studies requiring fewer subjects than larger trials.
  • Interpretationnone given

    REDCap carries out key functions by using one study metadata table that presentation-level operational modules reference.

    “REDCap accomplishes key functions through use of a single study metadata table referenced by presentation-level operational modules.”
    Quote in the paperSubstantial claim
  • Interpretationcitation

    The key to REDCap's success was making a simple workflow methodology that allows research teams to independently create study-related metadata efficiently.

    “we realized early in the project that the critical factor for success would lie in creating a simple workflow methodology allowing research teams to autonomously develop study-related metadata in an efficient manner.(3–5)”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [3] Nadkarni, 1995, SQLGEN: a framework for rapid client-server database application development, Comput Biomed Res source

      Not checked in the free run.

    • cites [4] Nadkarni, 2000, WebEAV: automatic metadata-driven generation of web interfaces to entity-attribute-value databases, J Am Med Inform Assoc source

      Not checked in the free run.

    • cites [5] Fraternali, 2000, Model-driven development of Web applications: the AutoWeb system, ACM Trans Inf Syst source

      Not checked in the free run.

  • May combine two claims. 16
  • Classified as probably not a substantial claim. 16
  • May combine two claims.

    Findingown data

    The number of registered users per project has a median of 4, a mean of 5.1, and a range of 1 to 77.

    “An analysis of the number of registered users per project conveys information about the size and diversity of supported studies (median = 4, mean = 5.1, range = 1 to 77).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Findingnone given

    After the initial researcher demonstration meeting, IC support for a single project typically requires less than 60 minutes over the life of a study.

    “After the initial researcher demonstration meeting, IC support for a single project typically requires less than 60 minutes over the life of a study (including allowances for mid-study CRF modifications when necessary).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingreasoning

    Launching a new project takes little time, and that time is almost completely driven by how researchers define a structured, study-specific data collection plan.

    “The startup time required to launch a new project is short and almost entirely determined by researcher input in defining a structured study-specific data collection plan.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    REDCap was first developed and deployed at Vanderbilt University and now receives collaborative support from a broad consortium of domestic and international partners.

    “REDCap (Research Electronic Data Capture) was initially developed and deployed at Vanderbilt University, but now has collaborative support from a wide consortium of domestic and international partners.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    The total number of REDCap projects is currently 204 (clinical=189; basic=7; operational=8), with 156 active and 48 in prototype status.

    “The total number of projects is currently 204 (clinical=189; basic=7; operational=8), including 156 active projects and 48 projects in prototype (pre-production) status.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The first REDCap project went into production at Vanderbilt University in August 2004.

    “The first REDCap project was placed in production at Vanderbilt University in August, 2004.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The project creation process can take from under a day to more than a year to move from prototype to production, depending entirely on the research team's motivation and readiness.

    “The project creation process may take from less than a day to over a year to move from prototype to production status and depends entirely on the motivation and readiness of the research team in defining CRF requirements and launching the study.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Informatics investment for REDCap has usually not exceeded one person doing new module development, supporting investigators, and working with consortium partners.

    “Informatics investment has varied during the time of operation, but has typically not exceeded one person performing new module development work, supporting investigators and working with project consortium partners.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingreasoning

    Vanderbilt's Office of Research Informatics provides REDCap at no cost and views the small staff commitment (under 0.5 FTE) as worthwhile, giving researchers easy access to centralized resources that follow HIPAA best practices.

    “The Vanderbilt, University Office of Research Informatics offers REDCap services at no charge for scientific research teams and considers the modest personnel investment (< 0.5 FTE for universal training and support) a sound investment ensuring researchers have ready access to centralized resources compliant with HIPAA best practices.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Currently, 722 distinct people are registered as end-users across all clinical, basic, and operational projects; audit logs show that 363 of them actively took part in data entry or export.

    “The number of registered end-users for all clinical, basic and operational projects is currently 722 unique individuals, including 363 users known through audit logs to have actively participated in data entry or export.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Through the consortium approach, new REDCap modules, documentation and support processes, and language abstraction (English, Spanish, Japanese) have been added, and near- and long-term plans are regularly defined and refined.

    “Using this consortium approach, we have successfully added new REDCap modules, created documentation and support processes for adopting centers, added language abstraction (English, Spanish and Japanese versions currently available) and also regularly define and refine near- and long-term plans for improvement and added functionality.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    The number of projects per registered user has a median of 1, a mean of 1.5, and a range of 1 to 14.

    “An analysis of the number of projects per registered user conveys information about the diversity of supported users (median = 1, mean = 1.5, range = 1 to 14).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In August 2006, a pilot initiative was started to study how research informatics resources are developed and shared across academic institutions.

    “In August, 2006, we launched a pilot initiative to study the process surrounding developing and sharing research informatics resources across academic institutions (Figure 4).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    As of the paper, REDCap supports 286 translational research projects within an expanding collaborative network that includes 27 active partner institutions.

    “REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The initial REDCap demonstration meeting offers a chance for project-specific informatics consultation on data collection and storage, data validation procedures, data security and logging requirements, and forms layout.

    “The initial REDCap demonstration meeting provides an opportunity for project-specific informatics consultation concerning data collection and storage, data validation procedures, data security and logging requirements, and forms layout.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    REDCap was first made to support clinical research studies, but is now also used for basic science and operational databases for the CTSA organization.

    “REDCap was initially created to support clinical research studies, but we now also use the project to support basic science and operational databases for our CTSA organization (e.g. process database for managing REDCap projects, accounting activity for CTSA Community Engagement core).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The REDCap consortium now has 27 partners (26 domestic, 1 international) who collaborate on new development and support REDCap operations.

    “The REDCap consortium now consists of 27 partners (26 domestic, 1 international) collaborating on new development and providing support for REDCap operations.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    The REDCap project benefits from a consortium of academic institutions.

    “The project benefits from a consortium of academic institutions and we encourage others to consider joining the group of adopting and collaborating sites.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationnone given

    REDCap was deployed successfully and became widely known within the institution as a toolset and workflow for secure, web-based data collection services.

    “REDCap was successfully deployed and gained a wide reputation within the institution as a toolset and workflow for providing secure, web-based data collection services.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    Multiple elements play a role in REDCap's successful adoption within clinical and translational research.

    “Several factors contribute to REDCap’s successful implementation in the clinical and translational research enterprise.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The need for researcher-controlled data services and secure data collection, storage, and export is universal for any single- or multi-center research study.
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Interpretationnone given

    The flat-table structure used for collected research data is inefficient for data storage but very efficient for study setup and ideal for embedded data export procedures.

    “The flat-table structure used for collected research data is inefficient from a data storage standpoint, but very efficient from the perspective of study setup and ideal for embedded data export procedures.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationnone given

    The workflow for testing and refining prototypes guarantees a team-based approach to defining data before the study starts, which improves both the speed and the overall quality of study data.

    “The prototype testing and refinement workflow process ensures a team-based data definition strategy prior to study initiation, thereby improving the timeliness and overall quality of study data.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The need for researcher-controlled data services and secure data collection, storage, and export is universal for any single- or multi-center research study.
  • May combine two claims.

    Interpretationnone given

    The flat-table data model is simple to copy and adapt for individual studies and has been adequate for many different clinical and translational research studies across multiple academic research settings.

    “Although simplistic, this data model is easy to reproduce and tailor for individual research studies during the project creation process and has proven adequate for a wide variety of clinical and translational research studies seen in multiple academic research environments.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    Forms have field-specific validation code that is enough to ensure strong data integrity.

    “Forms contain field-specific validation code sufficient to ensure strong data integrity.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationnone given

    The metadata creation process led by researchers is quick and adaptable, but it discourages standard data naming, though teams often reuse data dictionary templates across studies.

    “The researcher-led metadata creation process is fast and flexible, but does not encourage the use of data naming standards, with the exception that data dictionary templates are typically reused by researcher teams across studies.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationnone given

    REDCap's hardware and software needs are modest, and it operates in Windows/IIS and Linux/Apache web server environments.

    “Hardware and software requirements are modest and the system runs in Windows/IIS and Linux/Apache web server environments.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    A standard REDCap project needs five separate tables kept in one MySQL database.

    “The standard REDCap project requires five distinct tables stored in a single MySQL database:”
    Quote in the paperNot a substantial claim
27 of 27
  • The paper relies on this without support.

    The need to collect and share data securely with numerous collaborators across academic departments or institutions is a formidable challenge.

    “However, the need to collect and share data in a secure manner with numerous collaborators across academic departments or even institutions is a formidable challenge.”
  • The paper relies on this without support.

    The need for researcher-controlled data services and secure data collection, storage, and export is universal for any single- or multi-center research study.

    “Most important, the need for researcher-controlled data services and secure data collection, storage and export is a universal need for any single- or multi-center research study.”
  • The paper relies on this without support.

    The academic research environment typically has many preclinical investigator-initiated research studies requiring fewer subjects than larger trials.

    “Although costs can be justified in large organizations running multiple sponsored clinical trials, the academic research environment is typically home to many preclinical investigator-initiated research studies requiring a fraction of the subjects needed for larger trials.”
3 of 3

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • REDCap is a secure, password-protected web application designed for research data capture that includes features to reduce missing data and optimize data quality.

    “REDCap (Research Electronic Data Capture) [54] is used for data collection, entry and management. REDCap is a secure, password-protected web application designed to support data capture for research studies that includes several features to reduce the amount of missing data and optimize data quality.”

    From Unified protocol for the discontinuation of long-term serotonin reuptake inhibitors in obsessive compulsive disorder: Study protocol and methods (2018) · cites this paper as [54]

    The Methods section describes REDCap as a web-based research data-collection application with user authentication, access controls, and validation features intended to ensure data quality. It does not say that those features reduce the amount of missing data; its reference to a “mandatory field type” concerns validating the type of an entry, not requiring an entry. (LLM, conf=0.85)

    Experimental — accuracy not yet measured
  • REDCap provides user-level access control, and changes with username, date, time, and modification are logged (audit trail) and can be controlled at any time.

    “REDCap [182, 183] will be used for data collection (interviews, online surveys). It provides user-level access control as it is only accessible to authorized personnel. To ensure traceability of relevant processing operations, changes with username, date, time, and modification are logged (audit trail) and can be controlled at any time.”

    From Efficacy of a transdiagnostic Internet prevention approach in adolescents (EMPATIA study): study protocol of a randomized controlled trial (2024) · cites this paper as [182]

    Methods §B (page unavailable) says access to forms depends on user privileges and that the Data Logging module lets users view all data transactions throughout a project. Methods §C says a logging table stores information about data changes and exports. The copy does not specify that each change is logged with a username, date, time, and modification, or that the audit trail can be controlled at any time. (LLM, conf=0.85)

    Experimental — accuracy not yet measured
  • The randomization table will be generated by an external researcher, who will be the only one with access to the original randomization table; enrolment and the generation of the allocation code will be automatized via REDCap and cannot be influenced by any member of the research team.

    “The randomization table providing the basis for the computerized allocation in REDCap [182, 183] will be generated by an external researcher, who will be the only one with access to the original randomization table. Enrolment and the generation of the allocation code will be automatized via REDCap [182, 183] and hence cannot be influenced by any member of the research team.”

    From Efficacy of a transdiagnostic Internet prevention approach in adolescents (EMPATIA study): study protocol of a randomized controlled trial (2024) · cites this paper as [182]

    Split into 2 atoms — 1 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured
  • REDCap is an example of a CTSA-funded clinical research software application that has grown beyond its single institutional use case to be shared with institutions across the world.

    “The Research Electronic Data Capture (REDCap) data management platform is an example of a CTSA-funded clinical research software application that has grown beyond its single institutional use case to be shared with institutions across the world [26].”

    From The REDCap consortium: building an international community of software platform partners (2019) · cites this paper as [26]

    The Introduction says REDCap was initially developed at Vanderbilt, and Results IV.B reports that it was shared through a consortium of 26 domestic and one international partner. Results IV.A links REDCap to a CTSA organization, but the passages do not establish that CTSA funded the software. The reported international reach is also narrower than “institutions across the world” may suggest. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • REDCap is a secure web application for building and managing online surveys and databases, designed to support data capture for research studies.

    “REDCap is a secure web application for building and managing online surveys and databases, designed to support data capture for research studies [26].”

    From The REDCap consortium: building an international community of software platform partners (2019) · cites this paper as [26]

    The Methods sections on study creation and the user interface describe REDCap as a secure, web-based application for creating study databases and collecting research data through electronic forms. The passages do not establish that it builds or manages online surveys specifically. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

Cites

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Authors
Harris, P. A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., & Conde, J. G.
Affiliations
  • Vanderbilt University (US)
  • Medical College of Wisconsin (US)
  • University of Puerto Rico System (PR)
Corresponding author
Harris, Paul A.
Venue
Journal of Biomedical Informatics
Publisher
Elsevier BV
Published
2009-04
Volume
42
Issue
2
Pages
377-381
ISSN
1532-0464 (ISSN-L)
OpenAlex
W2093274439
Cited by
51,384
References
5
Citations by year
2026: 5202 · 2025: 6530 · 2024: 6650 · 2023: 5897 · 2022: 6019 · 2021: 5548 · 2020: 4337 · 2019: 3000 · 2018: 2318 · 2017: 1841 · 2016: 1426 · 2015: 1083 · 2014: 703 · 2013: 414 · 2012: 227
FWCI
116.65
Type
journal article
Language
en
Open access
Locations
  • Journal of Biomedical Informatics (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Center for Research Resources (G12-RR-03051, 5 M01 RR 00095, M01RR000095, M01RR000058, KL2RR024977, TL1RR024978, UL1RR024975, G12RR003051)
  • National Institute on Minority Health and Health Disparities (G12MD007600)
Topics
  • Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
  • Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
  • Social Sciences › Decision Sciences › Information Systems and Management › Scientific Computing and Data Management
Keywords
REDCap, clinical research data management
MeSH terms
Clinical Trials as Topic, Data Collection, Humans, Medical Informatics, Software, Internet, Biomedical Research

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