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| Metadataspec |
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| Num | Criteria | Description |
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| 1 | Collected observations have a timing that is different from an associated event or intervention as a whole. | - If the data item represents some action during or after the event or intervention, it may be considered to have its own timing, and meet Criterion 1
- This criterion is less likely to apply to interventions records than to events records.
- A finding that is about part of an event, rather than the event as a whole, meets this criterion for the use of FA. An assessment of an event that is not about the whole of an event may be a "snapshot," an assessment at a point in time, or a "slice," an assessment over a period of time (i.e., evaluation interval) during the event.
- Assessments of parts of events (snapshots or slices) are represented in FA and may or may not have parent records
- If the FA dataset is split by parent domain, the applicant will decide which Events domain would have held a parent record for a parent-less FA record.
| | 2 | Collected observations require more than 1 variable for representation. | - This may be the case when:
- There are several items which may be grouped together. If so, the FA structure allows the use of FAGRPID, FACAT, or FASCAT to group the items.
- The observation is best represented in a Findings general observation class structure. If so, the FA structure allows the use of FAORRES, FAORRESU, and FAMETHOD for results, units, and methods respectively.
- There are multiple evaluators. If so, the FA structure allows the use of FAEVALID.
- The need to represent data which require more than 1 variable in a findings about structure, rather than by adding 2 or more supplemental qualifiers to an Events or Interventions domain, is driven by the fact that each supplemental qualifier is in a separate record that links only to the parent record.
| | 3 | Collected observations indicate the occurrence of pre-specified adverse events. | - Every record in the AE domain must represent an event that actually occurred. Therefore, AE probing questions that are answered in the negative (e.g., did not occur, unknown, not done) cannot be stored in the AE domain.
- All answers to probing questions about the occurrence of pre-specified adverse events (e.g., "Y", "N", or "NOT DONE") will be stored in the FA domain.
- For each "Y" response to a probing question there will be a record in the AE domain.
- The FA record and the AE record will be linked via RELREC.
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Creating FA Datasets
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.
| Metadataspec |
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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 | - 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 in Section x.x, How to Create New Specifications.
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