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 SE domain? So today we will go over a basic example for 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 unique data-driven mapping for a high level view of study.
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:
https://www.lexjansen.com/pharmasug/2010/CD/CD08.pdf