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The scope for the Immunogenicity Specimen Assessments (IS) domain has been expanded in the SDTMIG v3.4. It is now designed to map data pertaining to specimen-based assessments that measure the “presence, magnitude and scale of the immune response upon any antigen stimulation or encounter.” This expands the scope of the IS domain from the previous versions of SDTMIG (v3.2/v3.3), where the IS domain was defined to represent data pertaining to “assessments that describe whether a therapy provoked/caused/induced an immune response”.
This change in the IS domain scope for the SDTMIG v3.4 has impact on both lab (LB) and microbiology (MB) domain scope and data mapping, as well as the development and maintenance of controlled terminology for all three domains.
Join us for a webinar where we will discuss:
- A history and the rationales behind the IS domain scope update for the SDTMIG v3.4.
- A brief walkthrough of the IS domain new standard variables and high-level modeling guiding principles.
- Its impact on the LB and MB domain scopes.
- Its impact on controlled terminology in LB, MB and IS.
- A summary of planned future directions for refinements to IS and development of materials to support stakeholder implementation over time.
Presenters
- Kathleen Hectors, Data Collection Standards Expert, Janssen
- Dr. Jordan Li, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute
- Dr. Erin Muhlbradt Biomedical/Clinical Research Information Specialist (Contractor) Enterprise Vocabulary Services (EVS), National Cancer Institute
- Dr. Dan Sinnett, CDISC Expert, Emmes
- Joleen White, Head of Bioassay Development and Operations (PK, ADA, Biomarker), Clinical Development, Bill & Melinda Gates Medical Research Institute