A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data

• Published in: PLOS ONE Vol. 18; no. 11; p. e0294412
• Main Authors: Daher, André, Castro-Alves, Júlio, Amparo, Leandro, Pacheco de Moraes, Natalia, Araújo dos Santos, Thaís Regina, Gram dos Santos, Karla Regina, Siqueira do Valle, Cristiane, Hermoso, Maria, Catoia Varela, Margareth, Correa Oliveira, Rodrigo
• Format: Journal Article
• Language: English
• Published: Public Library of Science (PLoS) 22.11.2023; Public Library of Science
• Subjects: Brazil; Clinical trials; Data Accuracy; Evaluation; Evidence-based medicine; Humans; Medical research; Medicine; Medicine, Experimental; Pandemics; Q; R; Research Article; Science; Software; Brazil
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0294412

Monitoring of clinical trials is critical to the protection of human subjects and the conduct of high-quality research. Even though the adoption of risk-based monitoring (RBM) has been suggested for many years, the RBM approach has been less widespread than expected. Centralized monitoring is one of the RMB pillars, together with remote-site monitoring visits, reduced Source Data Verification (SDV) and Source Document Reviews (SDR). The COVID-19 pandemic promoted disruptions in the conduction of clinical trials, as on-site monitoring visits were adjourned. In this context, the transition to RBM by all actors involved in clinical trials has been encouraged. In order to ensure the highest quality of data within a COVID-19 clinical trial, a centralized monitoring tool alongside Case Report Forms (CRFs) and synchronous automated routines were developed at the clinical research platform, Fiocruz, Brazilian Ministry of Health. This paper describes how these tools were developed, their features, advantages, and limitations. The software codes, and the CRFs are available at the Fiocruz Data Repository for Research—Arca Dados, reaffirming Fiocruz’s commitment to Open Science practices.