Useful Links.....Canadian site

1-Health Canada
Federal department responsible for helping Canadians maintain and improve their health

2-Health Canada – Guidance for Clinical Trial Sponsors: Frequently Asked Questions
Frequently asked questions for conducting clinical trials

3-Health Canada – TCPS 2 Tutorial Course on Research Ethics (CORE)
Self-paced research ethics course

4-Canadian Institutes of Health Research (CIHR)

5-Canadian Cancer Trials 

6-Canada Trials

7-Therapeutic Products Directorate GCP  http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/index-eng.php

8-BioTalent Canada

9-Canadian Association of Professionals in Regulatory Affairs

10-CenterWatch

11-Drug Information Association

12-National Institutes of Health

13-Rx&D(formerly Pharmaceutical Manufacturers Association of Canada)

14-Division 5 Links: Canada’s Food and Drug Regulations

15-Canadian Institutes of Health Research – (PIPEDA Questions and Answers for Health Researchers)

16-The Health Products and Food Branch

17-Health Canada, Food and Drug Regulations, Part C (Drugs), Division 5:  This is the key legal document for inspections conducted by Health Products and Food Branch Inspectorate, The link will bring you to a pdf format document that includes all 9 divisions of Part C;  the Division we are interested in is Division 5 (Drugs for Clinical Trials involving Human Subjects) and it is contained within pages 94 to 103.

18–Health Products and Food Branch, Guidance for Clinical Trial Sponsors: Clinical Trial Applications:  This is a guidance document that outlines requirements for sponsors wishing to conduct clinical trials with drugs in human in Canada.  The link will give you access to the complete (43 pages) guidance document, effective 25 Jun2003.

19-Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans: This document (93 pages) is a policy statement that describes procedures for governing research involving human subjects in Canada. Sections 1 (Ethics Review), 2 (Free and Informed Consent), 3 (Privacy and Confidentiality) and 4 (Conflict of Interest) might be of special interest.  – Here is a link for you to access the Policy Statement (amended in 2010)

20-Tri-Council Policy Statement 2: New Materials for Revisions: NEW materials to review!

21-Therapeutic Products Directorate (TPD)
http://bit.ly/therapeutic-products-directorate
22-Medical Devices Bureau
http://bit.ly/medical-devices-bureau
23-Biologics and Genetic Therapies Directorate
http://bit.ly/biologics-and-genetic-therapies-directorate
24-Natural Health Products Directorate
http://bit.ly/natural-health-products-directorate

25-Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications (CTAs)
http://bit.ly/health-canada-guidance-for-ct-sponsors-cta
26-authorization to sell or import a drug for the purpose of a clinical trial in Canada.
Safe Medical Devices in Canada Fact Sheet
http://bit.ly/safe-medical-devices-in-canada
27-Biologics, Radiopharmaceuticals, and Genetic Therapies Fact Sheets
http://bit.ly/biologics-radiopharmaceuticals-genetic-therapies-fact-sheets
28-Guidance Document for Clinical Trials For Natural Health Products
http://bit.ly/guidance-for-clinical-trials-for-natural-health-products

29-Contact Canada
http://contactcanada.com
30-Canadian Cancer Trials
http://canadiancancertrials.ca
31-Ontario Life Sciences Asset Map
http://bit.ly/ontario-life-sciences-asset-map
32-Canadian Medtech Asset Map (HTX)
http://bit.ly/canadian-medtech-asset-map
33-Medtech RISE (HTX)
http://bit.ly/medtech-rise

34-BIOTECanada
http://biotech.ca
BIOTECanada is the national industry association with nearly 250 members located nationwide,
reflecting the diverse nature of Canada’s health, industrial and agricultural biotechnology sectors.
35-Canadian Association for Independent Clinical Research (CAICR)
http://caicr-acrci.net
CAICR is a non-profit association that promotes the development of independent clinical research in Canada.
36-Health Technology Exchange (HTX)
http://htx.ca
HTX supports and accelerates the growth of the medical and assistive technology sector in Ontario,
and nationally. Funding is available for approved programs.
37-Life Sciences Ontario (LSO)
http://lifesciencesontario.ca

38-MaRS EXCITE
http://bit.ly/mars-excite
MaRS EXCITE is a collaborative initiative between a range of stakeholders in Ontario’s health care
system that work together to help innovative health technologies get to market faster and improve
patient outcomes.
39-MEDEC
http://medec.org
MEDEC is the national association created by and for the Canadian medical technology industry.
40-Network of Networks (N2)
http://n2canada.ca
N2 is a not-for-profit incorporated organization and an alliance of Canadian research networks and
organizations working to enhance national clinical research capability and capacity.
41-Ontario Bioscience Innovation Organization (OBIO)
http://obio.ca
OBIO is a not-for-profit, membership-based organization engaged in the development of an integrated health innovation economy for Ontario and one that will become a global leader in providing health technology products and services to the international marketplace.
Ontario Brain Institute (OBI)
42-http://braininstitute.ca
OBI is a provincially-funded, not-for-profit research centre seeking to maximize the impact of
neuroscience and establish Ontario as a world leader in brain discovery, commercialization and care.
43-Ontario Institute for Cancer Research (OICR)
http://oicr.on.ca
OICR is an innovative cancer research and development institute dedicated to prevention, early
detection, diagnosis and treatment of cancer.
44-Ontario Network of Entrepreneurs (ONE)
http://bit.ly/ontario-network-entrepreneurs
The ONE is a collaborative network of organizations across Ontario, designed to help entrepreneurs,
businesses and researchers commercialize their ideas by providing a comprehensive suite of programs and services across the full commercialization continuum from idea to market.
45-Rx&D
http://canadapharma.org
Canada’s Research-Based Pharmaceutical Companies (Rx&D) is the national association representing the men and women who work for 50 research-based pharmaceutical companies in Canada.
46-The HUB – Health Research Solutions
http://hubresearch.ca
The HUB is a unified clinical research methods and services group at the Li Ka Shing Knowledge
Institute of St. Michael’s Hospital in Toronto.

47-Canadian Institutes of Health Research

48-Heart and Stoke Foundation of Ontario

49-Canadian Cardiovascular Society

50-Canadian Diabetes Association

51-Vascular Biology Working Group

 52– Risk Factor Modification Center at St Michael hospital Canada