Clinical Trials

Listed here, as a service, are the documents PIASA thought most relevant. The list is not exhaustive. Should you wish to search further you can access the Department of Health website: www.doh.gov.za

Clinical Trials - Regulatory requirements SOUTH AFRICA, 2012.xlsx

	Application to Conduct a Clinical Trial - Form CTF 1.pdf (298 KB)
	Application to Conduct a Clinical Trial - Form CTF 2.doc (762 KB)
	Application to Conduct a Clinical Trial - Form CTF 3.doc (758 KB)
	WMA Declaration of Helsinki[1] updated 2008.pdf (98 KB)
	Joint Position Statement on Clinical Trials FINAL 15 June 2007.pdf (115 KB)
	HPCSA Booklet 10- Ethical Guidelines - Informed Consent 2007.doc (25 KB)
	SA Good Clinical Practice Guidelines 2nd Ed- 2006 Part 1.pdf (28 KB)
	SA Good Clinical Practice Guidelines 2nd Ed - 2006 Part 2.pdf (101 KB)
	SA Good Clinical Practice Guidelines 2nd Ed - 2006 Part 3.pdf (81 KB)
	SA Good Clinical Practice Guidelines 2nd Ed - 2006 Part 4.pdf (101 KB)
	Panel Discussion-Future of clinical research in South Africa - 6 September 2006.ppt (109 KB)
	Principles of Clinical Trials PhRMA 2004.pdf (114 KB)
	ICH Guidelies for Good Clinical Practice E6 2002 ex EMEA revised version.pdf (579 KB)
	Information and Guidelines on Clinical Trials.doc (26 KB)
	HPCSA Booklet 9 - Clinical Trials 2002.doc (91 KB)
	Extract from Regulations 2003 to Medicines Control Act No 101 of 1965 - Clinical trials.doc (27 KB)
	ICH Good Clinical Practice Guidelines - 1996.pdf (380 KB)

Powered by