At the workshop hosted by JPMA (DS, KT3) on June 25, 2025, a survey was conducted regarding inquiries on e-Data submitted to PMDA. Results from the survey revealed that the most common inquiries were related to inconsistencies in documentation, such as differences in the MedDRA version and WHO-DD version listed in the Reviewer's Guide and Define.xml, as well as omissions regarding the presence of SUPPxx domains.
To address these inconsistencies, I created an R Shiny app by Vibe Coding using ChatGPT to check for inconsistencies across documents. Despite being a beginner in R, I successfully developed an app to resolve these issues efficiently. This presentation shares the insights gained from the development process.
Additionally, beyond creating e-CRT packages, I hope this example serves as a reference for utilizing Vibe Coding (not limited to R Shiny but potentially using Python or other tools) to develop apps that streamline workflows and improve efficiency in one's daily tasks.
Naoki Yoshida
Takeda
Enhancing Efficiency in e-CRT Creation for PMDA Through R Shiny App Development Using Vibe Coding
At the workshop hosted by JPMA (DS, KT3) on June 25, 2025, a survey was conducted regarding inquiries on e-Data submitted to PMDA. Results from the survey revealed that the most common inquiries were related to inconsistencies in documentation, such as differences in the MedDRA version and WHO-DD version listed in the Reviewer's Guide and Define.xml, as well as omissions regarding the presence of SUPPxx domains. To address these inconsistencies, I created an R Shiny app by Vibe Coding using ChatGPT to check for inconsistencies across documents. Despite being a beginner in R, I successfully developed an app to resolve these issues efficiently. This presentation shares the insights gained from the development process. Additionally, beyond creating e-CRT packages, I hope this example serves as a reference for utilizing Vibe Coding (not limited to R Shiny but potentially using Python or other tools) to develop apps that streamline workflows and improve efficiency in one's daily tasks.