Summary Report of the Inspections of Clinical Trials Conducted Under Voluntary Phase

(July 11, 2003)

Contact: Good Clinical Practices Compliance Unit
Tel: (613) 952-8173
Fax: (613) 952-9805
E-Mail: 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

July 11, 2003

03-108319-575

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

I am pleased to inform you that the summary report of the Inspections of clinical trials conducted under the voluntary phase is now available on the Health Products and Food Branch Inspectorate website, under the "drugs" heading at:

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 in 2002 by the Health Products and Food Branch Inspectorate (Inspectorate) during the voluntary and confidence building phase. 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 at the National Coordination Centre, by telephone at (613) 952-8173, by fax at (613) 952-9805, or by e-mail at jean_saint_pierre@hc-sc.gc.ca

Original signed by
Etienne Ouimette (for)

Jean Lambert
Director General

Cover Page

OUR MANDATE:

To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Health Products and Food Branch Inspectorate

Summary Report of the Inspections of Clinical Trials Conducted under Voluntary Phase

Supersedes:
New document

Date issued:
July 11, 2003

Date of implementation:
N/A

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