Num | Representation | Implementation |
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1 | Single FA Domain | - A single FA dataset.
- Observations will be grouped as applicable by values in FACAT and/or FASCAT.
| 2 | Split FA Domain | | 3 | Separate Domains | - Separate datasets where:
- The DOMAIN value is applicant-defined and does not begin with FA.
- All guidance for the FA Structure is adhered to.
- The --OBJ variable cannot be added to a standard Findings domain. A domain is either a Findings domain or a Findings About domain, not one or the other depending on the situation. When the --OBJ variable is included in a domain, this identifies it as an FA domain.
- Refer to guidance in Section x.x, How to Create New Specifications.
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