Roles and responsibilities for clinical trial safety reporting of significant safety issues and urgent safety measures
Information
Type
Page
Regulated products
Medical Devices
Topics
Clinical Trials, Safety
Published
January 8, 2024
Last updated
January 9, 2024
Description
Summarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs).
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)