Implementation of the REDCap System for Data Management in Human Tissue Bank
Keywords:
Tissue Banks, Tissue and Organ Procurement, Data Management, Data Warehousing, Data SystemsAbstract
Introduction: Regulations governing good practices in Human Tissue Banks (HTB) intended for therapeutic use stipulate that the electronic data management system must be secure, efficient, and traceable. In this context, Research Electronic Data Capture (REDCap) is an electronic data management system originally developed for the collection and management of data in clinical studies, offering a set of integrated functionalities. Objective: To describe the implementation and validation of REDCap as an electronic data management system in an HTB. Methodology: This is a descriptive validation study. Based on the criteria established by current legislation, a validation plan was developed to analyze the important functionalities aimed at ensuring the security and integrity of the data. The functions analyzed were (a) system access and user registration; (b) data export and backup; (c) report generation; (d) traceability; and (e) blocking against alterations. Results: During validation, it was possible to verify that the system has important access control mechanisms, activity logging, and providing complete traceability of entered and modified information. Furthermore, REDCap offers multiple export and backup options, ensuring continued access to information in contingency situations or operational failures. Conclusion: REDCap demonstrated satisfactory compliance with the security, integrity, and traceability criteria required by current regulations for HTBs. Moreover, its replicability may represent a viable alternative for managing electronic data in other healthcare services.
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1 Brönneke JB, Debatin JF. Digitalisierung im gesundheitswesen und ihre effekte auf die qualität der gesundheitsversorgung: digitalization of healthcare and its effects on quality of care. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2022 fev; 65 (3) :342-347. https://doi.org/10.1007/s00103-022-03493-3.
2 Corsi CAC, Scarpelini KCG, Bento RL, Del Pádua JB, Zitei-Baptista LF, Assunção-Luiz AV, et al. Is it safe to use bone tissue for transplants stored for more than five years in a human tissue bank? Cell Tissue Bank. 2025 set; 26: 38. https://doi.org/10.1007/s10561-025-10185-0.
3 Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada - RDC nº 707, de 1º de julho de 2022. Dispõe sobre as boas práticas em tecidos humanos para uso terapêutico. Brasília: Anvisa; 2022. [acesso em 25 abr. 2026]. Disponível em: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000707&seqAto=002&valorAno=2022&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true.
4 Patridge EF, Bardyn TP. Research Electronic Data Capture (REDCap). J Med Libr Assoc. 2018; 106 (1): 142-144. https://doi.org/10.5195/jmla.2018.319.
5 Garcia KKS, Abrahão AA. Research development using REDCap Software. Healthc Inform Res. 2021 oct; 27 (4): 341-349. https://doi.org/10.4258/hir.2021.27.4.341.
6 Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) — A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 apr; 42 (2): 377-381. https://doi.org/10.1016/j.jbi.2008.08.010.
7 REDCap Brasil. Início. São Paulo; [s.d.]. [acesso em 2026 abr 30]. Disponível em: https://www.redcapbrasil.com.br/
8 Silveira F. Guia RedCap. Campinas: Universidade Estadual de Campinas; 2016. [acesso em 2026 abr 25]. Disponível em: https://pt.scribd.com/document/510920821/Manual-Redcap
9 Agência Nacional de Vigilância Sanitária. Relatório de avaliação dos dados de produção dos bancos de tecidos: ano 2019. Brasília: Anvisa; 2020. [acesso em 2026 abr 25]. Disponível em: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/sangue-tecidos-celulas-e-orgaos/relatorio-de-avaliacao-dos-dados-de-producao-dos-bancos-de-tecidos/relatorio-de-avaliacao-dos-dados-de-producao-dos-bancos-de-tecidos-ano-2019.pdf/view
10 Brasil. Lei nº 9.434, de 4 de fevereiro de 1997. Dispõe sobre a remoção de órgãos, tecidos e partes do corpo humano para fins de transplante e tratamento e dá outras providências. Diário Oficial da União. 1997 fev. 5; p. 1. [acesso em 30 abr. 2026]. Disponível em: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=1&pagina=1&data=05/02/1997&totalArquivos=56.
11 Maré IA, Kramer B, Hazelhurst S, Nhlapho MD, Zent R, Harris PA, et al. Electronic data capture system (REDCap) for health care research and training in a resource-constrained environment: technology adoption case study. JMIR Med Inform. 2022 aug; 10(8): e33402. https://doi.org/10.2196/33402.
12 Marroquin Rivera A, Rosas-Romero JC, Castro SM, Suárez-Obando F, Aguilera-Cruz J, Bartels SM, et al. Implementing a RedCap-based research data collection system for mental health. Rev Colomb Psiquiatr (Engl Ed). 2021 jul; 50(Suppl 1): 110-115. https://doi.org/10.1016/j.rcpeng.2021.06.004.
13 Rashid R, Copelli S, Silverstein JC, Becich MJ. REDCap and the National Mesothelioma Virtual Bank: a scalable and sustainable model for rare disease biorepositories. J Am Med Inform Assoc. 2023 out; 30 (10): 1634-1644. https://doi.org/10.1093/jamia/ocad132.
14 Empresa Brasileira de Serviços Hospitalares. Research Electronic Data Capture (REDCap). Brasília; 2021. [acesso em 2026 abr 29]. Disponível em: https://www.gov.br/ebserh/pt-br/governanca/plataformas-e-tecnologias/redcap
15 Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, et al. The REDCap consortium: building an international community of software partners. J Biomed Inform. 2019 jul; 95: 103208. https://doi.org/10.1016/j.jbi.2019.103208.
16 Brasil. Lei nº 13.709, de 14 de agosto de 2018. Dispõe sobre a proteção de dados pessoais e altera a Lei nº 12.965, de 23 de abril de 2014 (Marco Civil da Internet). Diário Oficial da União. 2018 ago 15; p. 59. [acesso em 2026 abr 30]. Disponível em: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=15/08/2018&jornal=515&pagina=59&totalArquivos=215.
17 Ngamani L, Ajeh R, Mbuh A, Dzudie A, Duda SN. Implementation of a REDCap-based research data collection system in Cameroon. Stud Health Technol Inform. 2019; 264: 1708-1709. https://doi.org/10.3233/SHTI190608.
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Copyright (c) 2026 Luiz Henrique de Freitas Filho, Cristina de Carvalho Silva Neves, Gustavo Bregalda Mattos, Petrus de Paula Ribeiro, Helga Caputo Nunes Holzhausen, Maurício Etchebehere, Gustavo Constantino de Campos
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