Australia

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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Australia

Legislations

National Health and Medical Research Council Act (1992)
Therapeutic Goods Act (2009)
Privacy Act No. 119 (2009)

Regulations

Guidelines

Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (2003)
Keeping Research on Track: A guide for Aboriginal and Torres Strait Islander Peoples about Health Research Ethic (2006)
National Statement on Ethical Conduct in Human Research (2007)
Australian Code for the Responsible Conduct of Research (2007)
Human Research Ethics Committees and the Therapeutic Goods Administration (2001)
Australian Clinical Trial Hand Book (2006)

Opinion Poll

Which of the following general ethical issues to conduct clinical trials?

	Widespread agreement that sound ethical standards must be observed in clinical research
	To participants subject irrespective of the geographic
	Economic setting in which Clinical Trial is undertaken
	Obtaining consent from a participant under access to better healthcare and payment
	A lack of appropriately trained people and resources in ethics committees

This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

Biomarkers World Europe (22/05/12)

World Gene Therapy Congress 2012 (22/05/12)

Exploratory Clinical Development World Europe (22/05/12)

World Animal Health Congress Asia (11/06/12)

World Vaccine Congress Asia 2012 (11/06/12)

Opinion Poll

Links