Good Clinical Practice:

Regulations Amending the Food and Drug Regulations (1024 — Clinical Trials)

http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/food_drug_reg_amend_1024_gcp_e.pdf

ICH Guidance E6: Good Clinical Practice: Consolidated Guideline

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e6_e.pdf

General Considerations for Clinical Trials ICH Topic E8

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e8_e.pdf

Guidance for Clinical Trial Sponsors Clinical Trial Applications

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ctd_cta_guidance_e.pdf

ICH Guidance: E9: Statistical Principles of Clinical Trials

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e9_e.html

Notice: Release of New Guidance for Clinical Trial Sponsors: Clinical Trial Applications

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ctd_cta_notice_e.pdf

National Placebo Initiative Co-sponsored by the Canadian Institutes of Health Research and Health Canada

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/npi_notice_e.pdf

Inclusion of Women in Clinical Trials During Drug Development

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/women_e.pdf

Last updated:  07/19/2004

Web Curator -Deborah Dragoon