Drug Evaluation Committee Commonly used analysis shells and ADaM data for clinical study reports
December 2019
In the FY2019 DS Subcommittee Continuing Task Force 2, based on the results of a survey conducted among member companies of the JPMA DS Subcommittee (40 valid responses), we identified the analysis reports typically prepared for Clinical Study Reports (CSRs) and the output items included in them.Next, we identified the minimum required ADaM data structure and variables necessary to create these analysis reports. Based on these results, we prepared a document summarizing “the layout of analysis reports that can be standardized across companies (TFL Shell) and the ADaM data used for them.”Since many companies create analysis reports and ADaM data within their global organizations, this document is presented in both Japanese and English.
Commonly used analysis shells and ADaM data for clinical study reports (505KB)