Background Tuberculosis (TB) is an infectious disease and is among the top 10 causes of death in the world, and Brazil is part of the top 30 high TB burden countries. Data collection is an essential practice in health studies, and the adoption of electronic data capture (EDC) systems can positively increase the experience of data acquisition and analysis. Also, data-sharing capabilities are crucial to the construction of efficient and effective evidence-based decision-making tools for managerial and operational actions in TB services. Data must be held secure and traceable, as well as available and understandable, for authorized parties.

Objectives In this sense, this work aims to propose a blockchain-based approach to build a reusable, decentralized, and de-identified dataset of TB research data, while increasing transparency, accountability, availability, and integrity of raw data collected in EDC systems.

Methods After identifying challenges and gaps, a solution was proposed to tackle them, considering its relevance for TB studies. Data security issues are being addressed by a blockchain network and a lightweight and practical governance model. Research Electronic Data Capture (REDCap) and KoBoToolbox are used as EDC systems in TB research. Mechanisms to de-identify data and aggregate semantics to data are also available.

Results A permissioned blockchain network was built using Kaleido platform. An integration engine integrates the EDC systems with the blockchain network, performing de-identification and aggregating meaning to data. A governance model addresses operational and legal issues for the proper use of data. Finally, a management system facilitates the handling of necessary metadata, and additional applications are available to explore the blockchain and export data.

Conclusions Research data are an important asset not only for the research where it was generated, but also to underpin studies replication and support further investigations. The proposed solution allows the delivery of de-identified databases built in real time by storing data in transactions of a permissioned network, including semantic annotations, as data are being collected in TB research. The governance model promotes the correct use of the solution.

背景 结核病 (TB) 是一种传染病，是世界十大死因之一，巴西是前 30 个结核病高负担国家之一。数据收集是健康研究的一项基本实践，采用电子数据采集 (EDC) 系统可以积极增加数据采集和分析的经验。此外，数据共享能力对于为结核病服务的管理和运营行动构建高效和有效的循证决策工具至​​关重要。数据必须保持安全和可追溯，并且可供授权方使用和理解。

目标 从这个意义上说，这项工作旨在提出一种基于区块链的方法来构建可重复使用、分散和去识别化的结核病研究数据数据集，同时提高 EDC 系统中收集的原始数据的透明度、问责制、可用性和完整性。

方法 在确定挑战和差距之后，考虑到其与结核病研究的相关性，提出了解决这些问题的解决方案。区块链网络和轻量级实用的治理模型正在解决数据安全问题。研究电子数据采集 (REDCap) 和 KoBoToolbox 在结核病研究中用作 EDC 系统。还可以使用去标识化数据和聚合数据语义的机制。

结果 使用 Kaleido 平台构建了一个许可的区块链网络。集成引擎将 EDC 系统与区块链网络集成，执行去标识化和聚合数据意义。治理模型解决了正确使用数据的运营和法律问题。最后，管理系统有助于处理必要的元数据，并且可以使用其他应用程序来探索区块链和导出数据。

结论 研究数据不仅对于产生它的研究来说是重要的资产，而且对于支持研究复制和支持进一步的调查也是重要的。提议的解决方案允许通过将数据存储在许可网络的事务中（包括语义注释）来实时构建去标识化数据库，因为数据是在 TB 研究中收集的。治理模型促进解决方案的正确使用。