The clinical trials have now been uniformed for Therapeutic Goods Administration (TGA) which consists of 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 provides 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 requirements which includes :-
- Treatment of subject (including products, treatment period, sample group.)
- Assessment of efficacy (efficacy parameters, analysis)
- Assessment of safety
- Statistics (justified report with the level of significant data)
- Direct Access to source data
- Quality Control & Quality assurance
- Business ethics
Human Research Ethics Committee (HREC) plays a vital role in approval of clinical research in Australia including human rights in a clinical trial context under the TGA.