The Findings About Events or Interventions structure, referred to as the FA Structure in this section, represents collected data about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. The variable --OBJ is unique to the FA Structure and is used with FATESTCD to represent what the topic of the observation is. FATESTCD describes the measurement/evaluation and FAOBJ describes the event or intervention that the measurement/evaluation is about. When collected data will be represented in a qualifier variable and are represented in the FA domain, the name of the variable will be used as the value of FATESTCD (e.g., FATESTCD = "OCCUR" and FATEST = "Occurrence Indicator"). The use of the same names (e.g., OCCUR) for both qualifier variables in the observation classes and FATESTCD is deliberate, but should not lead implementers to conclude that the collection of such data (e.g., occurrence) must be stored in the FA domain. In fact, data should only be stored in the FA domain if they do not fit in the general observation-class domain. If the data describe the underlying event or intervention as a whole and share its timing, then the data should be stored as a qualifier of the general observation-class record. A record in FA may or may not have a parent record in an events or interventions domain. If an FA record does have a parent record, the value in FAOBJ should match the value in --TERM or --TRT, unless the parent domain is dictionary coded or subject to controlled terminology. In such cases, the value represented in which case FAOBJ should will match the value represented in --DECOD.
When to Use the FA Structure
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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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Naming Findings About DomainsCreating FA Datasets
Applicants may choose to represent data in a single FA dataset (potentially splitting the FA domain into physically separate datasets following the guidance described in Section 4.1.6, Additional Guidance on Dataset Naming), split FA datasets, or in separate datasets , assigning with unique custom 2-character domain codes (see examples in Section 6.4.5, Skin Response)..
| Metadataspec |
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| Num | Representation | Implementation |
|---|
| 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 |
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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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