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Knowledge Base Article

Are These Findings Just Repeats or Were They Scheduled at Time Points?

… Just Repeats or Were They Scheduled at Time Points? The SDTMIG’s description of time point variables covers two … number in --TPTNUM and, optionally, a name in --TPT In the SDTMIG v3.3, a new findings variable for Repeat Number, … a planned schedule based on a reference time point. … The SDTMIG’s description of time point variables covers two …
Knowledge Base Article

Special Values: "MULTIPLE" and "OTHER"

… Special Values: "MULTIPLE" and "OTHER" The SDTMIG directs that, under certain circumstances, variables … collection form. The "MULTIPLE" convention is introduced in SDTMIG in the section on Multiple Values for a Non-Result … a fragment that is an abbreviation for the drug name. The SDTMIG section "Specify" Values for Non-Result Qualifier …
Knowledge Base Article

Subject Visits and COVID-19

… The special purpose Subject Visits structure in the SDTMIG is quite rigid, including only certain variables, and … described in the TCG, the public review version of SDTMIG v3.4 included SV as an events domain. As the result of public review feedback, the final SDTMIG v3.4 included this revised SV domain as a special …
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, …