Eliassen Group’s Biometrics and Data Solutions recently hosted the CDISC (Clinical Data Interchange Standards Consortium) NJ User Group meeting in their Somerset NJ office. The goal of this meeting was to bring members of the local CDISC organization together for information on the latest standards updates and additions. There were some fantastic and highly informative presentations on the following topics:
Lex Jansen (SAS) described how to utilize the new functionality in the Define.XML version 2.0 to show traceability. Through a series of examples, Lex showed how the new version supports the inclusion of analysis metadata.
Max Kanevsky (Pinnacle 21) discussed the most common issues seen on the Define.XML submissions. He pointed out that users of the Version 1 Define were missing out on some new functionality included in Version 2 which facilitate analysis for regulatory reviewers. Validation errors encountered included metadata inconsistency and missing metadata, particularly when it came to submitting controlled terminology.
Joyce Hernandez (Eliassen Group) discussed the SDTM (Study Data Tabulation Model) Version 1.5 Model that very recently underwent public review. It focused on the new variables that were added to the model and their respective functionality. Joyce provided a background on the use cases prompting the requests for these new variables and identified those designated only for SEND use. The presentation covered new variables added to the model within the following areas:
- Pharmacogenomics (Genetic Variations)
- All Observation Classes
- Subject Disease Milestones
- Domain specific
We were thrilled to share these additions and updates that will continue to promote higher quality medical research.