Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004

December 14, 2004

Contact: Good Clinical Practices Compliance Unit
Telephone: 613-952-8173
Fax: 613-952-9805
Email: GCP_BPC@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch Inspectorate
Holland Cross, Tower A, 2^nd Floor
11 Holland Avenue
Address Locator: # 3002C
Ottawa, Ontario
K1A 0K9

December 14, 2004

04-118942-280

To: Associations, Pharmaceutical Sponsors, Clinical Research Investigators, Research Ethics Boards

Health Canada is pleased to inform you that the "Summary report of the Inspections of clinical trials conducted in 2003-2004" is now available on the Health Products and Food Branch Inspectorate website, under the "Drugs" heading at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

This document provides the results, examples and an analysis of findings of inspections of clinical trials conducted during the fiscal year 2003 / 2004 by the Health Products and Food Branch Inspectorate (Inspectorate). Inspections of clinical trials are part of on-going activities performed by the Inspectorate to assess compliance of stakeholders to the regulatory framework of Division 5 of the Food and Drug Regulations, "Drugs for clinical trials involving human subjects" (Clinical Trial Regulations).

Inquiries or comments about this document can be addressed to Mr. Jean Saint-Pierre, Coordinator, Good Clinical Practices, Compliance and Enforcement Coordination Division at the Inspectorate, by telephone at (613) 952-8173, by fax at (613) 952-9805, or by email at GCP_BPC@hc-sc.gc.ca.

Sincerely,

Original signed by
Etienne Ouimette (for)

Jean Lambert
Director General

Cover Page

Our Mandate

Health Canada's mission is to help the people of Canada maintain and improve their health. With that mission in mind, the Health Products and Food Branch's mandate is to take an integrated approach to the management of the risks and benefits to health related to health products and food by minimizing health risk factors for Canadians while maximizing safety provided by the regulatory system for health products and food and promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

Health Products and Food Branch Inspectorate

Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004

Supersedes:
New document

Date Issued:
December 14, 2004

Date of implementation:
N/A

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