Rodrigues, Lídia Maria LourençönSilva, Fabricio Alves Barbosa daCorreia, Ricardo João CruzRijo, Rui Pedro Charters LopesAlves, Domingos2025-10-152025-10-152017Lídia Maria Lourençön Rodrigues, Fabricio Alves Barbosa da Silva, Ricardo João Cruz Correia, Rui Pedro Charters Lopes Rijo, Domingos Alves, Proposal of a gold standard database model of adverse drug reactions reports, Procedia Computer Science, Volume 121, 2017, Pages 883-888, ISSN 1877-0509, https://doi.org/10.1016/j.procs.2017.11.1141877-0509http://hdl.handle.net/10400.8/14273During the post-marketing period, when the drugs are used by large populations and for longer periods of time, unexpected adverse reactions (AR) may occur, which changes the risk-benefit ratio of the drugs, requiring a Regulatory action. Most post-marketing AR requires a significant increase in health care and result in damage, often fatal, to the patient. Therefore, the early detection of AR in the post-marketing period is the primary goal of a health system, in particular, pharmacovigilance systems. The main objective of this article is to show the stages of the development of an AR notification database to serve as the "gold standard" of a pioneering project in Brazil to process data automatically from the inclusion of electronic reporting systems into the Hospital Information Systems (HIS).engAdverse reactionsDatabasePharmacoepidemiologyjournal article10.1016/j.procs.2017.11.114