Roles AND Responsibilities Clinical Trial Safety Reporting Significant Safety Issues AND Urgent Safety Measures
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways/clinical-trials/roles-and-responsibilities-clinical-trial-safety-reporting-significant-safety-issues-and-urgent-safety-measures
Rules Mate indexes Australian government compliance resources to make them searchable. We link to + summarise; always verify the live source before acting.