Drug Evaluation Committee Layout of Analysis Forms for Summary Report and Examples of ADaM Data to be Used
Data Science Subcommittee
December 2019
Based on the results of a survey conducted among the member companies of the DS Subcommittee of the Pharmaceutical Manufacturers Association of Japan (40 valid responses), Task Force 2 identified the analysis forms that are commonly created for the Clinical Study Report (CSR) and the output items of those forms. Next, we identified the minimum ADaM data structure and variables required to create these analysis forms. Based on these results, we created a document that summarized "the layout of analysis forms (TFL Shell) that can be shared among companies and the ADaM data to be used for them. Since many companies prepare analysis forms and ADaM data in their global organizations, this document is written both in English and Japanese.
Layout of analysis forms and examples of ADaM data used in the summary report (515KB)
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