Fast-paced compliance arcade. Map clinical variables across SDTM domains (DM, VS, AE, LB), sign electronic submissions, and survive FDA auditor scrutiny.
Click invalid observations on active subject packets to convert non-standard units (e.g. lbs to kg) and format timestamps to ISO-8601 standard.
Route packets to stations (1: DM, 2: VS, 3: AE, 4: LB) and authenticate electronic signatures with meaningful submission intent before the conveyor expires.
Expired records or fraudulent non-compliant submissions raise auditor suspicion. If suspicion reaches 100%, an FDA Form 483 warning is issued and the trial is terminated!