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  • A document that describes the data standardization strategy for clinical and nonclinical studies within a development program. NOTE: A Study Data Standardization Plan is intended to include historical, current, and planned information about the use of study data standards for studies to conform with the current technical formats, and terminologies described in the FDA Data Standards Catalog which applies to CDER, CBER, and CDRH. [After http://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf, https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources, https://www.fda.gov/media/102719/download] See also standards, data standards, CDISC standards, and Standards Development Organization.
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