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Knowledge Base Article

How should I represent whether a physical exam was performed in SDTM?

… annotated as PROCCUR where PRTRT = "PHYSICAL EXAMINATION". SDTMIG v3.4 describes this CDASH best practice and includes … used in SDTM." Users implementing earlier versions of the SDTMIG who are dealing with data collected according to the … Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple …
Knowledge Base Article

LOINC and the SDTM

… LOINC. CDISC is preparing mappings of common LOINC codes to SDTMIG variable values   Further Reading Recommendations for … Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, …
Knowledge Base Article

Changing Event Severity

… vertical lines indicate times represented in records in an SDTMIG domain. Text in the arrows show values of --SEV. 1) The SDTMIG assumptions for the AE domain allow a sponsor to … Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple …
Instructor

Johannes Ulander

… Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, …
Knowledge Base Article

Considerations for Using CDISC Standards in Observational Studies

… Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, …
Knowledge Base Article

Providing Review-Ready Results in SDTM

… Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, …
Knowledge Base Article

Why Are Certain SDTM Variables "Not for Use in Human Clinical Trials"?

… Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, …
Knowledge Base Article

Concept Maps for Adverse Events with Increasing Levels of Detail

… Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, …
Knowledge Base Article

Concept Maps for Substance Administration with Increasing Levels of Detail

… Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, …
Knowledge Base Article

Concept Maps for a Finding with Increasing Levels of Detail

… Promotion Group page . Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple … of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, …