Department for Health and Ageing Policy & Legislation

Research Governance Policy
http://www.sahealth.sa.gov.au/wps/wcm/connect/0fb971004aaf196b9a0dfa7633bbffe0/directive_research+governance+policy_v3_jan2016.pdf?mod=ajperes&cacheid=0fb971004aaf196b9a0dfa7633bbffe0&cache=none

South Australian Public Health Act 2011 – (Data Access/Confidentiality Part 13 Section 99)
https://www.legislation.sa.gov.au/lz/c/a/south%20australian%20public%20health%20act%202011/current/2011.21.un.pdf

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)
National_statement_may_2015_150514_a.pdf

Australian Code for the Responsible Conduct of Research
Australian_Code_for_the_Responsible_Conduct_of_Research.pdf

Ethical Considerations in Quality Assurance and Evaluation Activities
https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e111_ethical_considerations_in_quality_assurance_140326.pdf

Guidelines Under S95 of the Privacy Act
Guidelines_under_s95_privacy_act_1988_141111.pdf

Guidelines approved under Section 95A of the Privacy Act 1988 (2014)
Guidelines_under_s95a_of_the_privacy_act_140311.pdf

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
https://government.archives.sa.gov.au/sites/default/files/20160719%20Prem%20Cab%20Circ%2012%20-%20amended%20June%202016%20-%20with%20Proclamation%20FINAL.pdf

Short Guide to the IPPs
http://government.archives.sa.gov.au/sites/default/files/20150703%20Short%20Guide%20to%20the%20Information%20Privacy%20Principles%20Final%20V1.pdf

Privacy and Open Data Guidelines:
http://government.archives.sa.gov.au/sites/default/files/20150703%20Privacy%20and%20Open%20Data%20Guideline%20Final%20V1.2.pdf

Code of Ethics
Code-of-Ethics-for-the-South-Australian-Public-Sector

Clinical Trials

Australian Clinical Trials

https://www.australianclinicaltrials.gov.au/

Medicines Australia (CTRA & Indemnity)

https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/
https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/

Therapeutic Goods Administration (TGA)

Access to Unapproved Therapeutic Goods
http://www.tga.gov.au/publication/access-unapproved-therapeutic-goods-clinical-trials-australia

The Australian Clinical Trials Handbook
http://www.tga.gov.au/sites/default/files/clinical-trials-handbook.pdf

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

Training

Good Clinical Practice (GCP)

http://www.tga.gov.au/publication/note-guidance-good-clinical-practice
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 (http://www.transceleratebiopharmainc.com/gcp-training-attestation/).

List of GCP Training Partners of TransCelerate Biopharma Inc
http://www.transceleratebiopharmainc.com/gcp-training-attestation/list-of-training-providers/

ARCS GCP Course
http://www.arcs.com.au/events/interest-areas-committee-meetings-2

INC IATA & GCP Refresher Training
https://www.incrclinicaleducation.com/Account/Registration

Professional Development

ARCS: https://www.arcs.com.au/events

Australian Clinical Trial Alliance (ACTA): http://www.clinicaltrialsalliance.org.au/

Praxis:  http://www.praxisaustralia.com.au/

University of Melbourne – Master of Clinical Research
https://coursesearch.unimelb.edu.au/grad/1862-master-of-clinical-research

University of New South Wales – Pharmaceutical Medicine 2018 Prospectus
https://med.unsw.edu.au/sites/default/files/_local_upload/UNSW%20Pharmaceutical%20Medicine%202018%20Prospectus.pdf

 

 

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