Zdrowie i gospodarka · 2/6/2014
Study Data Technical Conformance Guide and Data Standards Catalog; Availability
The Food and Drug Administration (FDA) is announcing the availability of a Study Data Technical Conformance Guide and an update to the Data Standards Catalog (formerly the Study Data Standards Catalog). The Study Data Technical Conformance Guide supplements the revised draft guidance for industry "Providing Regulatory Submissions in Electronic Format--Standardized Study Data" and provides specifications, recommendations, and general considerations on submitting standardized study data using FDA supported data standards specified in the Data Standards Catalog.