The United States Food and Drug Administration (FDA) requires that clinical trial data be submitted in the Study Data Tabulation Model (SDTM) standard format. The process of developing SDTM involves mapping captured raw data to their correspondent SDTM domains based on rules and conditions put by the Clinical Data Interchange Standards Consortium (CDISC) organization. SDTM data is further used for building the Analysis Data Model (ADaM) which is used for clinical trial statistical analysis. Mistakes in the mapping process are common due to the process complexities; issues that are missed may potentially affect the clinical trial result. Therefore, it is very essential to preserve the quality of the SDTM data. Currently, the main tool for checking SDTM conformance is Pinnacle21 (formerly known as OpenCDISC). Notably, there are usability and viability checks that are not included in Pinnacle21. This work describes the creation of an R shiny app to supplement the Pinnacle21 checks. This interactive app applies various CDISC-compliant SDTM data validation checks, and provides the user with a comprehensive report on possible inconsistencies in the data. The app would allow programmers to proactively find data mapping errors. In addition, it is straightforward to use and can save tremendous amounts of time. Additionally, this app’s audience extends beyond the programming community and covers other individuals who have an interest in data quality, particularly Data Managers and individuals in Clinical Science and Clinical Operations.
Elma Zannatul Ferdousy | Katrina Paz | Nasser Al Ali
Genentech | Genentech | Genentech
The Magic R-Shiny App that can Boost your SDTM Usability and Viability while Saving Time
The United States Food and Drug Administration (FDA) requires that clinical trial data be submitted in the Study Data Tabulation Model (SDTM) standard format. The process of developing SDTM involves mapping captured raw data to their correspondent SDTM domains based on rules and conditions put by the Clinical Data Interchange Standards Consortium (CDISC) organization. SDTM data is further used for building the Analysis Data Model (ADaM) which is used for clinical trial statistical analysis. Mistakes in the mapping process are common due to the process complexities; issues that are missed may potentially affect the clinical trial result. Therefore, it is very essential to preserve the quality of the SDTM data. Currently, the main tool for checking SDTM conformance is Pinnacle21 (formerly known as OpenCDISC). Notably, there are usability and viability checks that are not included in Pinnacle21. This work describes the creation of an R shiny app to supplement the Pinnacle21 checks. This interactive app applies various CDISC-compliant SDTM data validation checks, and provides the user with a comprehensive report on possible inconsistencies in the data. The app would allow programmers to proactively find data mapping errors. In addition, it is straightforward to use and can save tremendous amounts of time. Additionally, this app’s audience extends beyond the programming community and covers other individuals who have an interest in data quality, particularly Data Managers and individuals in Clinical Science and Clinical Operations.