Inspection Strategy for Clinical Trials

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

January 15, 2002

01-118529-18

To: Associations

Subject: Inspection Strategy for Clinical Trials

I am pleased to inform you that the approved version of the "Inspection Strategy for Clinical Trials" is now available on the Inspectorate Website at:

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

This strategy was developed by the Health Products and Food Branch Inspectorate (HPFBI), in consultation with the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB). Comments received from our stakeholders on the draft version published on August 31, 2001 were considered.

The implementation of the inspection component of this inspection strategy starts in January 2002. Activities related to investigations will be performed as needed.

Further communications with representatives of stakeholders will take place in the Fall 2002 to obtain further feedback and communicate expectations of this new inspection function.

Inquiries about this document can be addressed to Jean Saint-Pierre, Coordinator, Good Clinical Practices, National Coordination Centre, Health Products and Food Branch Inspectorate 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
Daniele Dionne (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
Policy
Inspection Strategy for Clinical Trials

Supersedes
Draft issued August 31, 2001

Date issued
January 15, 2002

Date of implementation
January 15, 2002

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