Zdrowie i gospodarka · 20.05.2014
Electronic Study Data Submission; Data Standards; Availability of Validation Rules for Standard for Exchange of Nonclinical Data Formatted Studies
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), is announcing the availability of the Validation Rules for Standard for Exchange of Nonclinical Data (SEND) Formatted Studies document. CDER is making this document available to improve the standardization and quality of nonclinical data that are submitted to CDER as well as to improve the predictability of data quality and usefulness.