Department for Health and Ageing Policy & Legislation

Research Governance Policy

South Australian Public Health Act 2011 – (Data Access/Confidentiality Part 13 Section 99)

NHMRC Guidelines

Standardised Participant Information and Consent Forms
standardised Participant Information and Consent Form (PICF)

National Statement on Ethical Conduct in Human Research 2007 (updated May 2015)

Australian Code for the Responsible Conduct of Research

Ethical Considerations in Quality Assurance and Evaluation Activities

Guidelines Under S95 of the Privacy Act

Guidelines approved under Section 95A of the Privacy Act 1988 (2014)

SA Legislation & Regulations – Privacy Guidelines

Health Care Act (93—Confidentiality and disclosure of information)
Health Care Act 2008 (SA)

Information Privacy Principals (IPPs): State Government agencies ensure the protection of personal information by adhering to the Information Privacy Principles Instruction (IPPI) published by Premier and Cabinet

Short Guide to the IPPs

Privacy and Open Data Guidelines:

Code of Ethics

Clinical Trials

Australian Clinical Trials

Medicines Australia (CTRA & Indemnity)

Therapeutic Goods Administration (TGA)

Access to Unapproved Therapeutic Goods

The Australian Clinical Trials Handbook

Note for Guidance on Good Clinical Research Practice
TGA Guidance on GCP


Good Clinical Practice (GCP)
NALHN requires all principal investigators involved in clinical trials to hold current GCP certification.
Investigators who do not hold current GCP certification should arrange to undertake online GCP training provided by ARCS Australia or another acceptable GCP Course which has the minimum standards defined by TransCelerate Biopharma Inc (

List of GCP Training Partners of TransCelerate Biopharma Inc


INC IATA & GCP Refresher Training

Professional Development


Australian Clinical Trial Alliance (ACTA):


University of Melbourne – Master of Clinical Research

University of New South Wales – Pharmaceutical Medicine 2018 Prospectus



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