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What is a Clinical Trial?

Laws and Regulations–Clinical Trials

Health Canada:

US Federal Food, Drug, and Cosmetic Act:

US Food and Drug Administration (FDA):

US Code of Federal Regulations (CFR): Main Page:

Laws and Regulations – Privacy

Ontario Health Information Protection Act, 2004–Personal Health Information Protection Act (Schedule A) (“PHIPA”):

Personal Information Protection and Electronic Documents Act (“PIPEDA”)

Privacy Commissioner of Canada:

Information and Privacy Commission of Ontario:

Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) (U.S.):

Policies and Guidelines

Tri-Council Policy Statement: Ethical Conduct for research involving humans:

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH):

Declaration of Helsinki:

Funding Agencies


Ontario Ministry of Health & Long-term Care:

Ontario Cancer Research Network:

National Institutes of Health (U.S.):


Canadian Medical Protective Association (CMPA):

Frank Cowan Company Limited:

Health Insurance Reciprocal of Canada (HIROC):


Uniform Requirements for Manuscripts Submitted to Biomedical Journals:

Clinical Trials.Gov:

Articles and Caselaw:

Grimes v. Kennedy Krieger Institute, Inc. (2000) (informed consent), or