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The Clinical Data Interchange Standards Consortium (CDISC) is reminding the clinical research community that the FDA Binding Guidance goes into effect in December.
The Clinical Data Interchange Standards Consortium (CDISC) is reminding the clinical research community that the FDA Binding Guidance goes into effect in December. Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog.
Read the full release here