The FA domain
Observations about subjects are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically related observations with a common topic. Almost 80% of observations collected during the study (other than those represented in special purpose domains) can fit among three general observation classes: Interventions, Events, or Findings. An intervention captures administration information of therapeutic medications, investigational products, surgical procedures and any other substances that affect physiological changes in the body. Information about planned protocol milestones such as randomization, study completion and occurrences of incidents during the trial or prior to the trial is generally categorized in the event class domains.
Findings class addresses the observations resulting from planned evaluations to address specific questions made during the study. So, what if the information from the study does not fit into events or interventions as a whole but it says something more about them? Some of the collected data may not directly fit in the specific domain or its supplemental qualifier dataset, but it may give more information regarding event or intervention. In such a case, ‘Findings about (FA)’ domain can be utilized.
When to use the FA domain?
The FA domain is a general observation domain. SDTM defines general observation class which is further divided among three classes :
Because of the fact that the SDTM does not allow the addition of new variable, it is possible to use special purpose domains in addition to supplemental qualifiers in order to capture non-standard variables.
This is all the more necessary because in some studies it has been observed that collected observation from the CRF can not be be represented within an Event or in Intervention. A programmer should also keep in mind that it is not always easy to map information in supplemental qualifiers.
In such situations findings about domain models are utilized.
FA domain structure
The variable FAOBJ is very important to describe records in FA.
FAOBJ provides a description of the Event or Intervention that the measurement/evaluation is about. It is a required variable. The value in FAOBJ is required to match the value in the corresponding — TERM or –TRT variables in the event or intervention domain that FA is describing. When the parent domain is dictionary coded or subject to controlled terminology FAOBJ should match the value in –DECOD. Another important variable is FATESTCD which as the topic variable describes the measurement/evaluation.
Both FA and findings domain are exactly same in structure with the exception of — OBJ variable.
Also take into account that the following qualifiers are generally not used in FA — BODSYS, — MODIFY, — SEV, — TOXGR.
In the event that an FA record is related to an adverse event, the FA and the AE records would then need to be linked via RELREC.
Data having qualifiers that can be represented in Findings variables (units and methods), then the result and measurement unit can be represented in the FA domain in a single record, while other information (e.g., start and end times), if collected would appear in an Event record.