Zdrowie i gospodarka · 19.11.2014
Electronic Study Data Submission; Data Standards; Validation Rules for Study Data Tabulation Model Formatted Studies; Availability
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a document entitled "Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies." CDER is making this document available to improve the standardization and quality of clinical data submitted to CDER, as well as to improve the predictability of data quality and usefulness.