This article was written to explain why there are so many Analysis Data Model (ADaM) documents and to help the ADaM user see how they have been designed to work together.
The current Immunogenicity Specimen Assessments (IS) domain in the SDTMIG v3.4 is designed to represent data pertaining to specimen-based assessments that measure the “presence, magnitude and scale of the immune response upon an antigen stimulation or encounter.” Not only does the new domain definition better align with the scientific definition of “immunogenicity”, but it also expands the scope of the IS domain from the previous versions of SDTMIG (i.e., v3.2 and 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”.
Therapeutic Area User Guides (TAUGs) contain many useful examples, but it can be hard to find a useful example since there are over 40 TAUGs, and many TAUGs include examples that are useful outside a particular therapeutic area. The spreadsheet classifies TAUG examples by domain, so if a user has data that would be represented in a particular domain, the spreadsheet can identify TAUGs that might have examples relevant to their data.
This example shows data about a subject receiving phototherapy to treat psoriasis.