Clinical Trial Significant Safety Issue/Urgent Safety Measure safety reporting form (SSI/USM)
Information
Type
Form
Regulated products
Medical Devices
Topics
Clinical Trials, Safety
Published
January 8, 2024
Last updated
January 9, 2024
Description
This form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)