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