2022 Japan Interchange CDISC Virtual Conference

Currently, study data for new drug applications to PMDA must be CDISC-compliant, and datasets conforming to SDTM and ADaM standards are required. Since ADaM datasets are created based on SDTM datasets, it is important for those who create ADaM to know what the structures of datasets would be or how certain values would be populated or derived in SDTM beforehand. If certain items are missing or modification is necessary, it should be addressed at the time of SDTM creation so that successful and efficient creation of ADaM datasets are guaranteed.