The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
Camargo
AUGUST 22, 2021
The correct STF file-tags are used for datasets and corresponding data definition files. For Study Data Tabulation Model (SDTM) study data, a DM dataset (dm.xpt) and define.xml were submitted. A trial summary dataset (ts.xpt) containing the study start date in YYYY-MM-DD format is present.
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