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 

Guidance in this section describes how to read domain specifications provided in the sections listed above. Implementers should refer to these sections when reading this guidance.

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 expectations for the 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.

...