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What is a Clinical Trial?
- http://www.cancer.gov/clinicaltrials/learning/what-is-a-clinical-trial
- http://en.wikipedia.org/wiki/Clinical_trial
- http://clinicaltrials.gov/info/resources
Laws and Regulations–Clinical Trials
Health Canada: http://www.hc-sc.gc.ca/
- Guidance for Clinical Trial Sponsors: Clinical Trial Applications:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec_e.html - Good Clinical Practice: Consolidated Guideline
ICH Topic E6 http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6_e.html - Legislation and Guidelines (topics include Drug Products, Medical Devices, and Biologics, Radiopharmaceuticals and Genetic Therapies): http://www.hc-sc.gc.ca/dhp-mps/legislation/index_e.html
US Federal Food, Drug, and Cosmetic Act: http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
US Food and Drug Administration (FDA): http://www.fda.gov/
US Code of Federal Regulations (CFR): Main Page: http://www.gpoaccess.gov/cfr/index.html
Laws and Regulations – Privacy
Ontario Health Information Protection Act, 2004–Personal Health Information Protection Act (Schedule A) (“PHIPA”): http://www.health.gov.on.ca/english/providers/legislation/priv_legislation/priv_legislation.html
Personal Information Protection and Electronic Documents Act (“PIPEDA”)
http://www.privcom.gc.ca/legislation/02_06_01_01_e.asp
Privacy Commissioner of Canada: http://www.privcom.gc.ca/
Information and Privacy Commission of Ontario: http://www.ipc.on.ca/
- Order HO-004 re Hospital for Sick Children (March 7, 2007):
http://www.ipc.on.ca/index.asp?navid=53&fid1=7616
Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) (U.S.): http://www.hipaa.org/
Policies and Guidelines
Tri-Council Policy Statement: Ethical Conduct for research involving humans:
http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): http://www.ich.org
Declaration of Helsinki: http://www.cirp.org/library/ethics/helsinki/
Funding Agencies
CIHR: http://www.cihr.ca/
Ontario Ministry of Health & Long-term Care: http://www.health.gov.on.ca/
Ontario Cancer Research Network: http://www.ocrn.on.ca/
National Institutes of Health (U.S.): http://www.nih.gov/
Insurance
Canadian Medical Protective Association (CMPA): www.cmpa-acpm.ca
Frank Cowan Company Limited: http://www.hiroc.com
Health Insurance Reciprocal of Canada (HIROC): http://www.hiroc.com
Publications
Uniform Requirements for Manuscripts Submitted to Biomedical Journals:http://www.icmje.org/index.html#authorship
Clinical Trials.Gov: http://clinicaltrials.gov/
Articles and Caselaw:
Grimes v. Kennedy Krieger Institute, Inc. (2000) (informed consent) http://www.law.uh.edu/healthlaw/law/StateMaterials/Marylandcases/grimesvkennedykreiger.pdf, or http://biotech.law.lsu.edu/cases/research/grimes_v_KKI_rehearing.htm
Comment: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1447190