The document discusses the SDTM 3.1.2 Findings About (FA) domain. FA is used to store findings that do not fit in other domains or supplemental qualifiers. It provides examples of when to use FA, such as to store adverse event severity timings or details of a prerequisite condition not in the Medical History domain. The document also discusses how to relate unrelated FA data to the parent domain using multiple datasets linked with RELREC relationships. Important FA variables include FATEST/FATESTCD to describe measurements/events and FAOBJ to describe the event/intervention measured.

1. Finding everything about
Findings About (FA)
By
Ramesh Gali

2. SDTM 3.1.2 Domains
Classification Number of Domains
Findings 12 (DA|EG|IE|LB|MB|MS|PC|PE|PP|QS|SC|VS)
Events 5 (AE|CE|DS|DV|MH)
Trial Design 5 (TA|TE|TI|TS|TV)
Special Purpose 4 (DM|CO|SE|SV)
Interventions 3 (CM|EX|SU)
Relationships 2 (SUPPQUAL|RELREC)
Findings About 1 (FA)
Total of 32 Domains with 723 variables/columns definitions

3. When to Use FA?
• FA is a new domain created in SDTM 3.1.2
When to use FA:
• Data is stored in FA only when it does not fit in the other Domains or its Supplemental
Qualifier.
• If data do not describe an event or intervention as a whole.
• If data indicates symptoms of an event. (Not to confuse with CE)
• Solicited adverse events related information.
Example Scenarios to use FA:
• AE Severity timing. (AE timing/duration can be stored in AE domain but event’s
severity timings can be stored in FA).
• Units or Method of an Event or Intervention.
• Details of a prerequisite primary diagnosis/condition that is not collected in MH.
• Symptoms of an AE (ex: migraine) when symptom is not considered an AE.
• Solicited AEs question responses can be collected in FA. Use RELREC to link to
record in AE.

4. When not to use FA ?
If the data shares the event/intervention as a whole or if
the data shares the event/interventions timing as a whole
then such data should go into Supplemental Qualifier of
the domain not FA.

5. How to handle unrelated data in FA and
then relate to parent domain?
• Data can be split into multiple datasets of related data.
(Data splitting is introduced in SDTM 3.1.2)
• Domain = FA in all datasets while dataset name can be
different as FA--. (Ex: Findings about Clinical Events can be
named as FACE, while Findings about a custom domain RE can be
named as FARE).
• Use RELREC to link records across datasets. Note: In
RELREC to link record in RE with record in FARE,
assign RDOMAIN=FARE (4 characters, instead of two
character domain name).

6. Important Variables in FA
Important Variables:
– FATEST/FATESTCD: describes measurement/event.
– FAOBJ: describes event/intervention that the
measurement/evaluation is about.
– FASPID: Sponsor defined ID variable. Value will link the row
in FA to a row in parent domain. (It could be one-to-one or
one-to-many relationship and relation type is noted in
RELREC in RELTYPE variable).
Examples:
1. To capture severity of acne: FATEST=SEVERITY and
FAOBJ= ACNE.
2. To capture volume of a vomit: FATEST=VOLUME and
FAOBJ= VOMIT

7. Scenario 1

8. Scenario 1 continued…

9. Scenario 2