Summary

This document provides background information and guidance for a scientific expert reviewer to conduct scientific review, at the request of an ethics committee in Victoria, regarding early phase clinical trials. Early phase trials are described in the TGA Australian clinical trial handbook (March 2018) as non-therapeutic, exploratory trials in human participants who may be healthy volunteers or have a specific disease.

Details

Publication Type
Document
Topic
Policies and guidelines
Date Published
30 Aug 2019
Size
37 pages
Available format
pdf
Author
Department of Health & Human Services