SDTM: SE Subject Element Domain
Background Story :
One day, my friend 99 discussed with me if a patient is randomized but not treated has some lab results besides screening, how should we classify the EPOCH variable for him/her in the SE domain?
So today we will go over a basic example for the SE domain: Subject Element.
Purpose:
The SE stores treatment data linked together with demographic data and Trial Design data, which is possible to standardize and create a unique data-driven mapping for a high-level view of the study.
Basics:
SE (Subject Element) contains subject level data about the timings of each subject transition from one element period to the other (screening, treatment, follow-up) and the treatment information (active, non-active) from multiple sources.
Key Variables:
STUDYID, DOMAIN, USUBJID, SESEQ, ETCD, ELEMENT, SESTDTC, SEENDTC,TAETORD,EPOCH
Variable Derivation Rules:
1.SeseqSequential number is unique for the records within the domain by USUBJID.*2.ETCDElement Code is assigned (SCREEN, Treatment, Placebo, FUP).*3.ELEMENTDescription of Element is assigned.(Screening, Treatment info, Follow up).*4.SESTDTCStart date of the element depends on Planned Armrelates to Inform consent date, Reference start date, Treatment Exposure Date.*5.SEENDTCEnd date of the elements equal to the next SESTDTC of next element.*6.TAETORDPlanned Order of Elements within Arm is directly from TA*7.EPOCHEpoch is directly from TE.EPOCHit originated from to reference start/end date.
SE Mini Sample Data Set:
Note: The dataset is a dummy sample, real data will have different SESTDTC, SEENDTC dates
To end the story we started, SE would only keep the Screening record for a patient without treatment even he/she has follow-up records.
Thanks 99 for sharing a case study with me!
Happy Studying!
Ref: