In the pharmaceutical industry, TFLs can be generated through programming to support the final clinical study report. However, by referring to the TFL results, the medical writer needs to manually transcribe or copy/paste the outputs into the CSR. This entire process can consume several months, depending on the complexity of the study and regulatory requirements. To overcome this difficulty, we suggest using {quarto}, which can derive descriptions, narratives, inline tables, figures, etc., for the CSR. In this session, we will discuss the rationale and feasibility of using such a tool, and example solutions will be provided.
Vivian Chang
CIMS Global
Customize and Generate Clinical Study Report (CSR) document using {quarto}
In the pharmaceutical industry, TFLs can be generated through programming to support the final clinical study report. However, by referring to the TFL results, the medical writer needs to manually transcribe or copy/paste the outputs into the CSR. This entire process can consume several months, depending on the complexity of the study and regulatory requirements. To overcome this difficulty, we suggest using  quarto , which can derive descriptions, narratives, inline tables, figures, etc., for the CSR. In this session, we will discuss the rationale and feasibility of using such a tool, and example solutions will be provided.