Resources

The changing regulatory climate requires investigative sites to be informed about local, federal, and global regulations and guidelines more than ever. Several resources are provided here to provide quick access to important information from Health Canada, the ICH-GCP, and clinical guidelines from international advisory bodies.

Clinical Practice Guidelines

ACC/AHA Joint Guidelines These guidelines are a listing of the standards and updates related to diagnosis, management, and care of patients with cardiovascular disease from the American College of Cardiology and the American Heart Association. CCS Guidelines CCS Guidelines represent current recommendations for the prevention, diagnosis, treatment, and ongoing management of heart disease. These recommendations […]

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Health Canada Regulations

In this section you will find links to important and useful documents produced by Health Canada which relate to the regulatory functions of the Health Products and Food Branch Inspectorate. This group is responsible for the inspections and investigations of clinical trials in Canada and is closely aligned with the Therapeutic Products Directorate. Division 5 Regulations Division […]

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ICH-GCP E6 (R2)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The ICH GCP Guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, […]

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