useR! 2024

Obtaining synthetic raw datasets, particularly for clinical trials, poses significant challenges. The reliance on manual data entry in Electronic Data Capture (EDC) systems, along with the creation of test data scenarios for generating Study Data Tabulation Model (SDTM) and other clinical programming tasks, presents complexities. syngenR, an R package, addresses these challenges by offering a solution that generates customized synthetic raw datasets for clinical trials. This presentation introduces an alternative to conventional test data generation and entry methods, addressing specific limitations and challenges of the current approach. By automating the creation of synthetic data that accurately reflects real-world variability, reliability, and efficiency of SDTM generation and other clinical programming tasks while avoiding the inaccuracies associated with manual data entry. This package can also be used in educational settings, and its capability to test various clinical trial scenarios, and its potential to significantly reduce the time and effort required for clinical trial preparation and execution.