2026 US Quality Core Implementation Guide
0.5.0 - release United States of America flag

2026 US Quality Core Implementation Guide - Downloaded Version 0.5.0 See the Directory of published versions

Example AdverseEvent: AdverseEvent example

identifier: 49476534

actuality: Adverse Event

category: Product Use Error

event: Generalized rash (disorder)

subject: Jim Chalmers Male, DoB: 1974-12-25 ( Social Security number (use: usual, period: 2001-05-06 --> (ongoing)))

date: 2017-01-29 12:34:56+0000

detected: 2017-01-29 12:34:56+0000

recordedDate: 2017-01-29 13:10:00+0000

seriousness: Non-serious

recorder: Practitioner Adam Careful

suspectEntity

instance: alemtuzumab 10 MG/ML [Lemtrada]

Causalities

-Assessment
*Possible