Vanderbilt University Medical Center serves as the Data Management and Coordinating Center for the studies by the RePORT-Brazil consortia, assisting in the development and maintenance of the case report forms (CRFs) and conducting regular on-site data monitoring visits. While the sites in Brazil record data on CRFs at the time the data are generated and in REDCap, the database resides in a secure Data Server that meets all physical, technical, and administrative HIPAA controls.
The Vanderbilt study program manager and data manager monitor the timeliness of data entry, the completeness of the data, and the consistency of the data across variables in the database. Any data queries that arise are documented and sent to the sites using REDCap’s Data Resolution Workflow/Queries feature. Sites are responsible for resolving data queries within 7 days. The program manager and team members also conduct regular on-site data monitoring visits to verify data quality and review protocol compliance.
Study Principal Investigator: Timothy R. Sterling
Study Co-Investigator: Catherine McGowan and Stephanie N. Duda
Program Manager: Marina C. Figueiredo
Data manager: Megan Turner
Biostatistician: Gustavo Amorim