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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. For example, 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 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. 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 events or interventions 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 FAOBJ will match the value represented in --DECOD.

When to Use the FA Structure TOBA-709 - Getting issue details... STATUS

The FA structure will be used when the following criteria are met:

NumCriteriaDescription
1The 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

Representation of a complex quality of an observation requires 2 or more related variables not in the events or interventions classes.

  • 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, a finding about an event that has a result with an associated unit. 
3Collected observations represent the occurrence of prespecified 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 prespecified 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. 


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.

NumRepresentationImplementation
1Single FA domain
  • A single FA dataset
  • Observations will be grouped as applicable by values in FACAT and/or FASCAT.
2Split FA domain
3Separate 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 2.8.3, How to Create New Specifications.

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