| Author | Daher, André | |
| Author | Alves, Júlio Castro | |
| Author | Amparo, Leandro | |
| Author | Moraes, Natália Pacheco de | |
| Author | Santos, Thaís Regina Araújo dos | |
| Author | Santos, Karla Regina Gram Dos | |
| Author | Valle, Cristiane Siqueira do | |
| Author | Hermosa, Maria | |
| Author | Varela, Margareth Catóia | |
| Author | Oliveira, Rodrigo Correa | |
| Access date | 2024-02-16T17:35:44Z | |
| Available date | 2024-02-16T17:35:44Z | |
| Document date | 2023 | |
| Citation | DAHER, André et al. A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data. PloS One, v. 18, n. 11, p. 1-14, Nov. 2023. | en_US |
| ISSN | 1932-6203 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/62655 | |
| Sponsorship | The Vice-presidency of Research and Biological Collections, Oswaldo Cruz Foundation (Fiocruz) / Ministry of Health of Brazil provided the funding. The funder had no rolein study design, data collection analysis,decision to publish, or preparation of the manuscript. | en_US |
| Language | eng | en_US |
| Publisher | Public Library of Science | en_US |
| Related document | https://doi.org/10.35078/QCXI6N | en_US |
| Rights | open access | en_US |
| Title | A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data | en_US |
| Type | Article | |
| DOI | 10.1371/journal.pone.0294412 | |
| Abstract | 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. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. National Institute of Infectious Disease Carlos Chagas. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. National Institute of Infectious Disease Carlos Chagas. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | Oswaldo Cruz Foundation. Presidency. Vice-presidency of Research and Biological Collections. Rio de Janeiro, RJ, Brazil. | en_US |
| Subject | Clinical trials | en_US |
| Subject | Risk-based monitoring (RBM) | en_US |
| Subject | Fiocruz Data Repository for Research - Arca Dados | en_US |
| Subject | Case Report Forms (CRFs) | en_US |
| Subject | COVID-19 | en_US |
| e-ISSN | 1932-6203 | |
