Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043)

October 23, 2006

Unit Name: GCP 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
Graham Spry Building, 3^rd Floor
250 Lanark Avenue
Address Locator # 2003D
Ottawa, Ontario
K1A 0K9

August 29, 2008

08-120024-781

To: Associations, Pharmaceutical Sponsors, Clinical Research Investigators, Research Ethics Board and all other interested parties,

I am pleased to inform you that Health Canada has revised the guidance document entitled "Classification of Observations made in the conduct of inspections of clinical trials", which is now available on Health Canada's Compliance and Enforcement website under "What's New".

The revisions are based on the comments received as a result of the publication of the orginal Guide-0043 on the Inspectorate website on October 20, 2006. All comments were carefully assessed and analysed. Several main issues were identified. The rationale for the decisions made respecting the issues identified by stakeholders is summarized and annexed to the revised Guide.

This guide is in effect as the date of this letter. Inquiries about this document can be addressed in writing to the GCP Coordinator, Good Clinical Practices Compliance Unit, by telephone at 613-952-8173, by fax 613-952-9805 or by e-mail at: GCP_BPC@hc-sc.gc.ca.

Yours truly,

Original signed by

Kim Dix for
Diana Dowthwaite
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

Classification of observations made in the conduct of inspections of clinical trials

GUIDE-0043

Supersedes:
October 23, 2006
(Draft posted for comments)

Date issued:
August 29, 2008

Date of implementation:
August 29, 2008

Disclaimer
This document does not constitute part of the Food and Drugs Act (Act) or the Food and Drugs Regulations (Regulations) and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

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