CodeSystem-fda-add-seriousness-criteria-cs

Source

hl7.fhir.uv.ae-research-ig#current:Adverse Event Clinical Research (v5.0.0)

resourceType

CodeSystem

fda-add-seriousness-criteria-cs

canonical

http://hl7.org/fhir/uv/ae-research-ig/CodeSystem/fda-add-seriousness-criteria-cs

version

1.0.0-ballot

status

draft

publisher

HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups

name

FDAaddSeriousnessCriteriaCS

title

FDA Additional Seriousness Criteria CodeSystem

date

2023-07-28T19:27:19+00:00

experimental

true

description

Additional codes found on https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event#:~:text=Required%20Intervention%20to%20Prevent%20Permanent%20Impairment%20or%20Damage%20(Devices),use%20of%20a%20medical%20product. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch).

jurisdictions

caseSensitive

true

content

complete

Usages

Adverse Event Seriousness Criteria (system)

This case-sensitive code system http://hl7.org/fhir/uv/ae-research-ig/CodeSystem/fda-add-seriousness-criteria-cs defines the following code:

Code	Display	Definition
requiresPreventImpairment	Required Intervention to Prevent Permanent Impairment or Damage (Devices)	Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product

Produced 08 Sep 2023