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DocumentClinical Data Acquisition Standards Harmonization
Short NameCDASH
Version1.1
ReleasedJanuary 2011
Excerpt
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The Clinical Data Acquisition Standards Harmonization (CDASH) Standard v1.1 was published in January 2011.

This page contains the working list of errata for the final version 1.1 of the CDASH Standard. These corrections will be incorporated into the next version of the document.

Section 5.3 Adverse Event domain

In Row 2, the Question Text should be a complete sentence (e.g., "What is the AE Identifier?")

Appendix E: Variable Naming Fragments

--DY should not be used to collect the 'day' portion of a date because this conflicts with the definition of --DY in SDTM.  In SDTM --DY is a Study Day calculated from the Reference Start Date (RFSTDTC) in Demographics (DM).  The variable fragment for the "day portion of a date" will be updated in the next version of CDASH.

--NY should be --YN to match the use of this fragment in published domains (e.g., AEYN, CMYN)