Preferred Label : Study Data Standardization Plan;
NCIt synonyms : SDSP;
NCIt related terms : Study Data Standardization Plan (SDSP);
NCIt definition : 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);
Alternative definition : CDISC-GLOSS: 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.;
NCI Metathesaurus CUI : CL979035;
Origin ID : C165840;
UMLS CUI : C5237481;
Semantic type(s)
- concept_is_in_subset
