Character Encoding, Japanese Text, and Why Your SDTM Package Can Fail Even When the Data Logic Is Fine
StudySAS • SDTM • Define.xml • Regulatory Submissions Character Encoding, Japanese Text and Why Your SDTM Package Can Fail Even When the Data Logic Is Fine Clean derivations and a valid define.xml are not enough if the transport layer, XML encoding, and metadata pipeline are not controlled end to end. Your SDTM derivations are correct. Your P21 run is clean. Your define.xml opens and looks fine. And yet, the package still trips up in review. Not because of the data. Because of encoding. PMDA expectation What PMDA expects, and why it trips teams PMDA’s Technical Conformance Guide states that if languages other than English are used, including Japanese, the character set and encoding scheme must be documented in the reviewer’s guide. Source: PMDA Technical Conformance Guide on Electronic Study Data Submissions, April 2024 This is not a footnote. It shows up ...