Related links

Organizations

• Northern Alberta Clinical Trials & Research Center
  Contact: Kathy Brodeur-Robb kbrodeur@cha.ab.ca
• Partnership Program Grants Officer, University of Calgary
  Contact: Fay Wilkinson - fwilkins@ucalgary.ca
• Health Trials Health Science Centre
  Contact: Leslie Stewart - healthtrials@hsc.mb.ca
• Manitoba Clinical Research Institute
• Office of Clinical Research, St. Boniface General Hospital
  Contact: April Hughes ahughes@sbgh.mb.ca
  Website: www.sbgh.mb.ca
• Health Care Corporation of St. John's
  Contact: Linda Purchase - lpurchas@mun.ca
  Website: www.hccsj.nf.ca
• Center for Clinical Research
  Contact: Lisa Underwood www.cdha.nshealth.ca
• Clinical Trials Division
  Website: www.clinicaltrialsdivision.com
• London Clinical Trials Research Group
  Website: www.lctrg.com
• Society of Clinical Research Associates (SoCRA)
  Website: www.socra.org
• Association of Clinical Research Professionals (ACRP) Website: www.acrpnet.org
• Clinical Research Excellence through Accreditation Training Education Website: www.createnetinc.com

• Canada's Research-Based Pharmaceutical Companies www.canadapharma.org

Studies

• CenterWatch www.centerwatch.com/
  - Clinical Trials Listing Service.
• ClinicalTrials.gov www.clinicaltrials.gov
  - The purpose of this site is to inform potential subjects about studies. It is the first comprehensive listing of federally funded trials in the United States. This site is expected to become the major online clearinghouse for private and publicly funded trials, and in the process, to help trial sites and other businesses get work, and track the industry.

Resources

• Bioethics Resources on the Web www.nih.gov/sigs/bioethics
• Interagency Advisory Panel on Research Ethics (PRE) www.pre.ethics.gc.ca
• CBER Dear Gene Therapy IND Sponsor / Principal Investigator Letter www.fda.gov/cber/ltr/gt110599.htm
  - At this site you can access a letter written by CBER's director, Kathryn Zoon, to all sponsors and principal investigators of gene therapy INDs to clarify serious adverse events (SAE) reporting requirements.
• Centers for Disease Control's Human Subjects Research www.cdc.gov/od/ads/hsr2.htm
  - It helps researchers determine what should go into a protocol, how to provide safeguards for children, pregnant women and genetics research. It includes forms for IRB review, guidelines for informed consent documents, sample IRB reports, an all-day training seminar for investigators and a two-hour "nuts and bolts" education session for investigators.
• Declaration of Helsinki www.wma.net/e/policy/17-c_e.html
• FDA Forms Distribution Page for CDER www.fda.gov/opacom/morechoices/fdaforms/cder.html
• FDA Guidance document and FAQs for Financial Disclosure by Clinical Investigators www.fda.gov/oc/guidance/financialdis.html
• FDA information www.fda.gov/oc/ohrt/irbs/default.htm
• Food and Drugs Act, Health Canada www.hc-sc.qc.ca/...."
• Manual of Regulatory Standard Operating Procedures and Policies www.fda.gov/cber/regsopp/regsopp.htm
  - Provides two new Standard Operating Procedures and Policies to notify NIH when FDA has received adverse event reports and protocol changes.
• NIH Office of Extramural Research - Office for Protection from Research Risks (OPRR) grants2.nih.gov/grants/funding/SBIRConf2000/Scharke/index.htm
• Health Information Protection Act www.health.gov.sk.ca/ph_br_health_leg_hipamain.html
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans www.nserc.ca/programs/ethics/english/ethics-e.pdf
• Health Canada - Health Products and Food Branch www.hc-sc.gc.ca/....
• Health Professional or Consumer Advisories for Health Products www.hc-sc.gc.ca/....
• MEDLINEplus www.medlineplus.gov/
• Saskatchewan Formulary Website: //formulary.drugplan.health.gov.sk.ca/

ICH/GCP

• FDA's Good Clinical Practice www.fda.gov/oc/gcp/default.htm
• FDA: For Good Clinical Practice and Clinical Trial Information www.fda.gov/oc/ohrt/irbs/websites.html
• Good Clinical Practice: Consolidated Guideline www.ncehr-cnerh.org/english/gcp/index.htm
  published by Health Canada.

Education

• Management Training for the Health Care Sector www.health.bcit.ca/hlthmgmt/index.html