31 - 40 of 330 results
Webinar
… Overview and discussion of major scope changes in SDTMIG v4.0 and SDTM v3.0 … SDTMIG v4.0 / SDTM v3.0 Public Review …
Webinar
… Specimen Assessments (IS) domain has been expanded in the SDTMIG v3.4. It is now designed to map data pertaining to … the scope of the IS domain from the previous versions of SDTMIG (v3.2/v3.3), where the IS domain was defined to … response”. This change in the IS domain scope for the SDTMIG v3.4 has impact on both lab (LB) and microbiology …
Known Issue
… LBSTREFC Core Attribute Should Not Have Been "Expected" in SDTMIG v3.3 Short Name LBSTREFC Core Attribute Should Not Have Been "Expected" in SDTMIG v3.3 Affected Standard SDTMIG v3.3 Description of Error LBSTREFC should not have …
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 …