Finding everything about findings about (fa)Presentation Transcript
Finding everything about Findings About (FA) By Ramesh Gali
SDTM 3.1.2 DomainsClassification Number of DomainsFindings 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
When to Use FA?• FA is a new domain created in SDTM 3.1.2When 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.
When not to use FA ?If the data shares the event/intervention as a whole or ifthe data shares the event/interventions timing as a wholethen such data should go into Supplemental Qualifier ofthe domain not FA.
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).
Important Variables in FAImportant 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