The clinical trials have now been uninformed by the Therapeutic Goods Administration (TGA) which employs principles of “Good Clinical Practice” or GCP. This aims to gain high quality, insightful and credible data that contributes to answering the specific scientific question before the manufacturer making any product claim.
GCP standards provide a benchmark of clinical research to be relied upon throughout the world, covering a basic guideline in terms of principles, ethics, scientific assessment & validation, etc. All clinical trials are required to meet GCP standards as a mandatory requirement which includes:-
Human Research Ethics Committee (HREC) plays a vital role in the approval of clinical research in Australia including human rights in a clinical trial context under the TGA.
