Finding everything about findings about (fa)
- 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
- 9. Scenario 2