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Applicants may choose to represent data in a single FA dataset, split FA datasets, or in separate datasets with unique custom 2-character domain codes.
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| 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 | |
For example, if findings about clinical events and findings about medical history are collected in a study, these could be represented as:
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- Split FA datasets per guidance in Section
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- The DOMAIN value would be “FA”.
- Variables that require a prefix would use “FA”.
- The dataset names would be the domain name plus up to 2 additional characters indicating the parent domain (e.g., FACE for Findings About Clinical Events, FAMH for Findings About Medical History). This naming convention may be used for an FA domain that has a parent domain even when the study has only 1 FA dataset that is not being split.
- FASEQ must be unique within USUBJID for all records across the split datasets.
- Supplemental qualifier datasets would need to be managed at the split-file level (e.g., suppface.xpt, suppfamh.xpt). Within each supplemental qualifier dataset, RDOMAIN would be "FA".
- If a dataset-level RELREC is defined (e.g., between the CE and FACE datasets), then RDOMAIN may contain up to 4 characters to effectively describe the relationship between the CE parent records and the FACE child records.
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- applicant-defined and does not begin with FA
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- 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.
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- When the --OBJ variable is included in a domain, this identifies it as an FA domain
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- Variables that require a prefix would use the 2-character domain code chosen.
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