DEFINITION :  The Trial Inclusion/Exclusion (TI) domain records the criteria used to determine subject eligibility for the trial. It includes both inclusion criteria (what qualifies a subject) and exclusion criteria (what disqualifies a subject).

PURPOSE : To track the rules that define which subjects can participate in the study, ensuring the trial’s population is aligned with its objectives. This helps manage study safety and the validity of results.

STRUCTURE : One record per I/E criterion

TOPIC : IETESTCD

KEY VARIABLES : STUDYID, IETESTCD