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U.S. Department of Health and Human Services

For Industry

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Subject Data Standard

The Subject Data standard captures information on an individual study subject including observations, substance administration, supplies, and procedures. FDA has determined that the HL7 v3 CDA R2 standard is capable of conveying the subject data represented by the proposed Subject Data standard (see below). Starting in early 2012 FDA will began balloting CDA R2 implementation guides for the exchange of specific types of subject data. The first guide to be balloted will be for the submission of patient narratives. The second guide will be for the submission CDSIC SDTM content as described in the SDTM 3.1.2 implementation guide.