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- NCIT_C165840 IAO_0000115 "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. (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)" @default.
- NCIT_C165840 NCIT_NHC0 "C165840" @default.
- NCIT_C165840 NCIT_P106 "Activity" @default.
- NCIT_C165840 NCIT_P108 "Study Data Standardization Plan" @default.
- NCIT_C165840 NCIT_P208 "CL979035" @default.
- NCIT_C165840 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C165840 NCIT_P325 "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." @default.
- NCIT_C165840 normalizedInformationContent "100" @default.
- NCIT_C165840 referenceCount "1" @default.
- NCIT_C165840 hasExactSynonym "SDSP" @default.
- NCIT_C165840 hasExactSynonym "Study Data Standardization Plan (SDSP)" @default.
- NCIT_C165840 hasExactSynonym "Study Data Standardization Plan" @default.
- NCIT_C165840 inSubset NCIT_C61410 @default.
- NCIT_C165840 inSubset NCIT_C67497 @default.
- NCIT_C165840 type Class @default.
- NCIT_C165840 isDefinedBy ncit.owl @default.
- NCIT_C165840 label "Study Data Standardization Plan" @default.
- NCIT_C165840 subClassOf NCIT_C165840 @default.
- NCIT_C165840 subClassOf NCIT_C25404 @default.
- NCIT_C165840 subClassOf NCIT_C25619 @default.
- NCIT_C165840 subClassOf NCIT_C43431 @default.