Statements (34)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:standard
|
| gptkbp:abbreviation |
Study Data Tabulation Model
|
| gptkbp:component |
CDISC standards
|
| gptkbp:developedBy |
Clinical Data Interchange Standards Consortium
|
| gptkbp:documentType |
tabulation datasets
|
| gptkbp:firstReleased |
2004
|
| gptkbp:fullName |
Study Data Tabulation Model
|
| gptkbp:governingBody |
gptkb:CDISC
|
| https://www.w3.org/2000/01/rdf-schema#label |
SDTM
|
| gptkbp:includes |
variables
domains controlled terminology |
| gptkbp:latestReleaseVersion |
2021
3.4 |
| gptkbp:purpose |
standardize structure and content of clinical trial data
|
| gptkbp:regulates |
gptkb:PMDA
gptkb:FDA |
| gptkbp:relatedStandard |
gptkb:ADaM
SEND CDASH Define-XML |
| gptkbp:supports |
regulatory review
data integration data sharing |
| gptkbp:usedBy |
gptkb:contract_research_organizations
regulatory agencies pharmaceutical companies biotechnology companies |
| gptkbp:usedFor |
submission of clinical trial data to regulatory authorities
|
| gptkbp:usedIn |
clinical trials
|
| gptkbp:website |
https://www.cdisc.org/standards/foundational/sdtm
|
| gptkbp:bfsParent |
gptkb:CDISC
gptkb:JMP_Clinical |
| gptkbp:bfsLayer |
8
|