The Use of CDISC Data Standards in FDA Electronic Submissions

The preferred format for submitting standardized study data to CDER and CBER are the Clinical Data Interchange Standards Consortium (CDISC) Foundational Standards, including the Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Standard for Exchange of Nonclinical Data (SEND). In 2011, approximately 30% of unique NDAs received by CDER and approximately 20% of BLAs received by CBER included CDISC/SDTM data....

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New FDA Study Data Specifications Differentiate Between SDTM, Legacy Formats

In January, FDA issued version 1.5.1 of Study Data Specifications. As discussed in my previous blog entry, a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered to indicate whether they were STDM or legacy format. The new specifications for organizing study datasets and their associated files in folders are summarized in the...

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