Page History

...

• Section 2.8.8, Specifications for Product Description
• Section 2.8.9, Specifications for Nonclinical
• Section 2.8.10 Specifications for Individual Health 

Domain specifications will be used with all guidance in this section and are organized with 1 specification per domain or dataset.All domain specifications begin with a description, expected name, and record structure for the resulting dataset. A domain specification table follows to describe dataset variables and their attributes. Assumptions for the domain are also provided to further guide implementation. Domain specification tables are structured to present 1 row for each variable with columns to describe expected attributes of the variable in resulting datasets. The order of variables in a domain specification table reflects the expected order of variables in the resulting dataset.

...