Development and automation of primary outcome data visualizations and reports

Authors

• MJ Duvenhage
• J Wang
• C Ying
• F Appiah
• S Debrincat
• K Arora
• D Armstrong
• L Via
• C Whalen
• CE Barry 3rd
• L Dodd

Abstract

The Biostatistical Research Branch at the National Institute of Allergy and Infectious Diseases have implemented a data workflow that is leveraging R data visualizations and data reporting plots specifically pertaining to the primary and secondary objectives of studies. Data Management and study teams often get overwhelmed with regards to data quality and cleaning, focusing on all data elements rather than the key study goals and ensuring appropriate data cleaning strategies are implemented and aimed at the primary and secondary objectives of the study. Automated data visualizations and primary outcome plots are mapped daily from the clinical data management system (using R code) to a shared study portal, accessible by data management, clinical, laboratory and other site team members. These reports ensure a focused approach and real-time quality assurance review of missing/outstanding laboratory results, CRF inconsistencies and data alarms pertaining to the primary and secondary endpoints of the study. This poster plans to motivate the development of data visualizations and data plots specifically around the primary and secondary study endpoints, ensuring a focused approach to data cleaning. These data visualizations enable high level engagement from the entire study team on critical data elements, facilitating the identification and escalation of data issues in an automated manner directly to all study team members. Clinical Research Directorate/Clinical Monitoring Research Program, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute. Funded by the NCI Contract No. HHSN261200800001E

Scientific Focus Area: Research Support Services

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