Exposure as Collected (EC) :

DEFINITION : The Exposure as Collected (EC) domain captures the raw exposure data as reported by the site, without converting it into a standard dose or format. It allows for the capture of original data without standardization.

PURPOSE : To preserve the original format of drug exposure data for regulatory submission and ensure accurate raw data collection.

STRUCTURE : One record per protocol-specified study treatment, collected-dosing interval, per subject

TOPIC : ECTRT

KEY VARIABLES : STUDYID, USUBJID, ECTRT, ECSTDTC