Now that the long-awaited SDTMIG 3.3 has been officially released, Pinnacle 21 team has eagerly began to implement validation rules for this new standard. As the first step, we performed a gap analysis for changes since SDTMIG 3.2. We excited to share our findings with the CDISC community, which you can find in the slides along with summary of changes below.

Summary of Changes

Datasets:

• 12 new datasets in SDTMIG 3.3
• Dataset description changed for 6 datasets
• Dataset structure changed for 18 datasets

Variables:

• 30 new variables listed in SDTM 1.7 model
• 130 Model Permissible variables now listed in SDTMIG 3.3
• Core value changed for 29 variables
• Variable label changed for 7 variables in SDTM 1.7
• Variable label changed for 86 variables in SDTMIG 3.3 (across all datasets)
• Codelist has been removed for 2 variables
• Codelist has been added for 21 variables
• Codelist has been changed for 8 variables
• Multiple codelists provided for 7 variables
• Role has been changed for 3 variables listed in SDTM 1.7
• Role has been changed for 33 variables listed in SDTMIG 3.3

Issues:

• 2 Variables modeled in SDTMIG 3.3 as Permissible for the domain, but are also listed in the Assumptions as Generally Not Used