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The Australian Clinical Trial Handbook - (194KB PDF). A simple, practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context.
CTN or CTX? An explanation of the difference
TGA Clinical Trials site - A wealth of information about undertaking clinical trials in Australia
Note for Guidance on Good Clinical Practice (with TGA annotations) The official guideline for GCP relating to clinical trials. Covers such things as Adverse events, How to get consent, Audits, Investigator responsibiliites etc
National Statement on Ethical Conduct in Human Research 2007 is attached below. This statement was developed jointly byNational Health and Medical Research CouncilAustralian Research CouncilAustralian Vice-Chancellors’ Committee and covers Ethical aspects of undertaking human research including consent, tissue banking, databanks, stem cells and processes of governance and ethical review.
Power point presentations on Good Clinical Practice (GCP)
Overview of GCP 6 slides
12 Golden Rules of GCP 15 slides
Investigator responsibilities 4 slides
Informed consent 12 slides
Adverse events 14 slides
Source documentation 7 slides
Audits by regulatory authorities Common errors, 7 slides
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