31 - 40 of 330 results
Knowledge Base Article
… When Would I Use ISO8601 Interval Format? In SDTMIG v3.4 and SDTM v2.0, formats for Date/Time variables … are less familiar, even though they're mentioned in the SDTMIG and SENDIG. The ISO 8601 standard allows an interval … would I use ISO8601 interval format" is "rarely." … In SDTMIG v3.4 and SDTM v2.0, formats for Date/Time variables …
Knowledge Base Article
… Transport Files Background When development of the SDTM and SDTMIG started, SAS was in almost universal use in the … At that time, the CDISC volunteer team who developed the SDTMIG was focusing on drug submissions to FDA, so it was assumed that SDTMIG had to work with the SAS V5 transport file format. …
Knowledge Base Article
… class dataset, especially if data are about findings. The SDTMIG says, "A domain is defined as a collection of … physical examination, vital signs) for some of the earliest SDTMIG domains*. Note: new domains are no longer created … findings domain(s). *The earliest version of the SDTMIG was heavily influenced by the1999 FDA guidance, " …
Knowledge Base Article
… values that appear in various examples published in the SDTMIG and TAUGs have sometimes included the domain code, and sometimes not. The SDTMIG Appendix for Supplemental Qualifiers Name Codes … with a domain code in a current or future version of the SDTMIG. The only domains other than general observation …
Knowledge Base Article
… how to represent data for a study, they first consult the SDTMIG and SDTM to find the appropriate standard variable. If no appropriate standard variable is found, the SDTMIG directs them to create a supplemental qualifier, also … called a non-standard variable. Examples published in the SDTMIG or in Therapeutic Area User Guides (TAUGs) illustrate …
Knowledge Base Article
… documenting study subject site transfers, using existing SDTMIG domains and minimal supplemental qualifiers. … who transferred sites. This example has been updated in SDTMIG v3.4, where DSEPCHGI as a standard variable: Example … pandemic. Note that DSEPCHGI is a new standard variable in SDTMIG v3.4. For prior versions, this variable would be …
Knowledge Base Article
… published the first of a new kind of QRS supplement to the SDTMIG, a supplement for an oncology response criterion, … published the first of a new kind of QRS supplement to the SDTMIG, a supplement for an oncology response criterion, … and formatting data for human and animal studies, the SDTMIG is intended to guide the organization, structure, and …
Knowledge Base Article
… 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" 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
… 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 …