Originally Published MX March/April 2008
BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT
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- “Good Clinical Practice in FDA-Regulated Clinical Trials” [online resource] (Rockville, MD: FDA, 2008 [cited 15 February 2008]); available from Internet: www.fda.gov/oc/gcp/.
- “Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001,” Official Journal of the European Communities L121 (2001): 34–44; available from Internet: www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf.
- Ethical Principles for Medical Research Involving Human Subjects (Ferney-Voltaire, France: World Medical Association, updated 2004); available from Internet: www.wma.net/e/policy/b3.htm.
- Good Clinical Practice for Clinical Research in India (New Delhi: Central Drugs Standard Control Organisation, 2005); available from Internet: http://cdsco.nic.in/html/GCP1.html.
- Provisions for Clinical Trials of Medical Devices (Beijing: State Food and Drug Administration, 2003); available from Internet: http://eng.sfda.gov.cn/cmsweb/webportal/W45649039/A56659191.html.
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