Frameworks de qualidade de dados 

EM-BRA-INM-0043

Referências:
1. Zebachi S, Tanniou J, Bakker E, de Vries ST, Di Bidino R, Xoxi E, et al. Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies. Clin Pharmacol Ther. 2025;118(4):894–905. 
2. Riskin DJ, Monda KL, Gagne JJ, Reynolds R, Garan AR, Dreyer N, et al. Implementing Accuracy, Completeness, and Traceability for Data Reliability. JAMA Netw Open. 2025;8(3):e250128. 
3. European Medicines Agency (EMA). Data quality framework for EU medicines regulation: application to real-world data (EMA/503781/2024). 2024 [internet] [acesso em 21 jan. 2026]. Disponível em: https://www.ema.europa.eu/en/documents/other/draft-data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf 
4. Cézar de Aquino N, Reichert CO, Lage APC, Culler HF, Rotberg FSR, Rocha V, et al. Advancing real-world evidence in Brazil: regulatory gaps and global lessons. Lancet Reg Health Am. 2025;55:101344. 
5. Miller R, Chan SHM, Whelan H, Gregório J. A comparison of data quality frameworks: a review. Big Data Cogn Comput. 2025;9:93. 
6. Candore G, Martin C, Mills MJ, Suter A, Lloyd A, Chavez-Monteya D, et al. FRAME: Framework for real-world evidence assessment to mitigate evidence uncertainties for efficacy/effectiveness—an evaluation of regulatory and health technology assessment decision making. Clin Pharmacol Ther. 2025;118(3):649–61. 
7. European Network for Health Technology Assessment (EUnetHTA). Registry evaluation and quality standards tool (REQueST): feasibility documentation. Joint Action 3, 2016–2020. Version validated in 2019. 2020 [internet] [acesso em 21 jan. 2026]. Disponível em: https://catalogues.ema.europa.eu/system/files/202502/05.01.0301%20Feasibility%20Documentation%20%20Registry%20Evaluation%20and%20Quality%20Standards%20Tool%20%28REQueST%29%20_%2010-Sep-2023_Redacted.pdf