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| Metadataspec |
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| Num | Criteria | Description |
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| 1 | The timing of collected observations is different from the timing of the 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 | More than 1 variable is required to represent the collected observations. | Representation of a complex quality of an observation requires 2 or more related variables not in the events or interventions classes.
| Criterion 2: An observation about an event or intervention which requires more than 1 variable for its representation, particularly when the observation may be represented with Findings class variables (e.g., units, method) 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. For example, if the size of a rash is measured, then the result and measurement unit (e.g., centimeters, inches) can be represented in an FA domain in a single record; other information regarding the rash (e.g., start and end times) would, if collected, appear in an Event record. See, for example, the longest diameter measurements in Section 6.4.4., Findings About Events or Interventions, Example 2. | | 3 | Collected observations represent 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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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. 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.
Creating 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.
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