Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap)
There is a growing trend for studies run by academic and nonprofit organizations to have regulatory submission requirements. As a result, there is greater reliance on REDCap, an electronic data capture (EDC) widely used by researchers in these organizations. This paper discusses the development and...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2025-01-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S205986612400671X/type/journal_article |
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| author | Theresa A. Baker Teresa Bosler Adam L.C. De Fouw Michelle Jones Paul A. Harris Alex C. Cheng |
| author_facet | Theresa A. Baker Teresa Bosler Adam L.C. De Fouw Michelle Jones Paul A. Harris Alex C. Cheng |
| author_sort | Theresa A. Baker |
| collection | DOAJ |
| description | There is a growing trend for studies run by academic and nonprofit organizations to have regulatory submission requirements. As a result, there is greater reliance on REDCap, an electronic data capture (EDC) widely used by researchers in these organizations. This paper discusses the development and implementation of the Rapid Validation Process (RVP) developed by the REDCap Consortium, aimed at enhancing regulatory compliance and operational efficiency in response to the dynamic demands of modern clinical research. The RVP introduces a structured validation approach that categorizes REDCap functionalities, develops targeted validation tests, and applies structured and standardized testing syntax. This approach ensures that REDCap can meet regulatory standards while maintaining flexibility to adapt to new challenges. Results from the application of the RVP on recent successive REDCap software version releases illustrate significant improvements in testing efficiency and process optimization, demonstrating the project’s success in setting new benchmarks for EDC system validation. The project’s community-driven responsibility model fosters collaboration and knowledge sharing and enhances the overall resilience and adaptability of REDCap. As REDCap continues to evolve based on feedback from clinical trialists, the RVP ensures that REDCap remains a reliable and compliant tool, ready to meet regulatory and future operational challenges. |
| format | Article |
| id | doaj-art-53fb47d9330847abbdb2e1a7fe2e9bb2 |
| institution | Kabale University |
| issn | 2059-8661 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj-art-53fb47d9330847abbdb2e1a7fe2e9bb22025-01-16T21:49:12ZengCambridge University PressJournal of Clinical and Translational Science2059-86612025-01-01910.1017/cts.2024.671Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap)Theresa A. Baker0https://orcid.org/0000-0002-2068-5989Teresa Bosler1Adam L.C. De Fouw2Michelle Jones3https://orcid.org/0009-0008-1548-6740Paul A. Harris4https://orcid.org/0000-0002-1744-2011Alex C. Cheng5https://orcid.org/0000-0002-1787-691XVanderbilt Institute for Clinical and Translational Research, University Medical Center, Nashville, TN, USA Division of Biomedical Informatics, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USAVanderbilt Institute for Clinical and Translational Research, University Medical Center, Nashville, TN, USADepartment of Medicine, University of Wisconsin-Madison, Madison, WI, USAVanderbilt Institute for Clinical and Translational Research, University Medical Center, Nashville, TN, USAVanderbilt Institute for Clinical and Translational Research, University Medical Center, Nashville, TN, USA Departments of Biomedical Informatics, Biostatistics, Biomedical Engineering, Vanderbilt University Medical Center, Nashville, TN, USAVanderbilt Institute for Clinical and Translational Research, University Medical Center, Nashville, TN, USAThere is a growing trend for studies run by academic and nonprofit organizations to have regulatory submission requirements. As a result, there is greater reliance on REDCap, an electronic data capture (EDC) widely used by researchers in these organizations. This paper discusses the development and implementation of the Rapid Validation Process (RVP) developed by the REDCap Consortium, aimed at enhancing regulatory compliance and operational efficiency in response to the dynamic demands of modern clinical research. The RVP introduces a structured validation approach that categorizes REDCap functionalities, develops targeted validation tests, and applies structured and standardized testing syntax. This approach ensures that REDCap can meet regulatory standards while maintaining flexibility to adapt to new challenges. Results from the application of the RVP on recent successive REDCap software version releases illustrate significant improvements in testing efficiency and process optimization, demonstrating the project’s success in setting new benchmarks for EDC system validation. The project’s community-driven responsibility model fosters collaboration and knowledge sharing and enhances the overall resilience and adaptability of REDCap. As REDCap continues to evolve based on feedback from clinical trialists, the RVP ensures that REDCap remains a reliable and compliant tool, ready to meet regulatory and future operational challenges.https://www.cambridge.org/core/product/identifier/S205986612400671X/type/journal_articleElectronic data capturesoftware validationregulatory complianceclinical research |
| spellingShingle | Theresa A. Baker Teresa Bosler Adam L.C. De Fouw Michelle Jones Paul A. Harris Alex C. Cheng Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap) Journal of Clinical and Translational Science Electronic data capture software validation regulatory compliance clinical research |
| title | Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap) |
| title_full | Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap) |
| title_fullStr | Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap) |
| title_full_unstemmed | Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap) |
| title_short | Consortium-driven rapid software validation for Research Electronic Data Capture (REDCap) |
| title_sort | consortium driven rapid software validation for research electronic data capture redcap |
| topic | Electronic data capture software validation regulatory compliance clinical research |
| url | https://www.cambridge.org/core/product/identifier/S205986612400671X/type/journal_article |
| work_keys_str_mv | AT theresaabaker consortiumdrivenrapidsoftwarevalidationforresearchelectronicdatacaptureredcap AT teresabosler consortiumdrivenrapidsoftwarevalidationforresearchelectronicdatacaptureredcap AT adamlcdefouw consortiumdrivenrapidsoftwarevalidationforresearchelectronicdatacaptureredcap AT michellejones consortiumdrivenrapidsoftwarevalidationforresearchelectronicdatacaptureredcap AT paulaharris consortiumdrivenrapidsoftwarevalidationforresearchelectronicdatacaptureredcap AT alexccheng consortiumdrivenrapidsoftwarevalidationforresearchelectronicdatacaptureredcap |