References

Web links

Links to external resources

NHMRC – National Statement on Ethical Conduct in Research Involving Humans (2007)

http://www.nhmrc.gov.au/publications/synopses/e72syn.htm

Declaration of Helsinki (World Medical Association)

http://www.wma.net/e/policy/b3.htm
Document can be downloaded from http: //www.wma.net/e/policy/17c.pdf

Therapeutic Goods Administration (the regulatory body in Australia)

http: //www.tga.gov.au/index.htm

There are specific sections in the TGA website for clinical trials in Australia:
see http: //www.tga.gov.au/ct/index.htm

International Conference on Harmonisation guidelines

http://www.ich.org/cache/compo/276-254-1.html

The ICH Guidelines cover 4 areas:

• Q: Quality (assurance)
• E: Efficacy
• S: Safety (for preclinical research)
• M: Multi-disciplinary issues not covered by Q, E or S

Most clinical trials issues are covered under the “E” topics, such as:

• Good Clinical Practice (GCP): E6
• General Considerations of Clinical Trials: E8
• Statistical Principles for Clinical Trials: E9

European Medicines Agency (European Regulatory authority)

http://www.emea.europa.eu

For human medicines: http://www.emea.europa.eu/index/indexh1.htm

Food and Drug Administration (US regulatory body)

http://www.fda.gov/

http://www.fda.gov/oc/gcp/default.htm

http://www.fda.gov/oc/gcp/guidance.html

National Cancer Institute

http://www.cancer.gov/clinicaltrials

Australian New Zealand Clinical Trials Registry

http://www.anzctr.org.au