TI: SDTM Trial Inclusion/Exclusion Dataset

Background:

Today we will go over Trial Inclusion/exclusion dataset. The TI datasets contain all the inclusion and exclusion criteria for the trial, such as subject age, lab or other findings, or maybe medical history. We can fetch the info from IE(inclusion/exclusion) dataset specifications or protocol.

Note: TI is NOT subject-oriented.

Sample Spec:

Sample output:

Note:
In real clinical trials, we would have a lot more IETEST (Inclusion/Exclusion) Criterions based on the study design. This is an extremely simplified and universal sample.

Ref:https://www.slideshare.net/ankurpandit/trial-design-domains

Happy Studying !