Regulatory and Ethics Support for Clinical Trials

Companies and institutions undertaking clinical trial research face an increasingly challenging and complex regulatory environment.  A member of the Faculty of Law at the University of Ottawa, and with almost 20 years working on the ethics and regulation of clinical trials at elite institutions including the US National Institutes of Health, University of Toronto and University of Chicago, Gordon DuVal Consulting:

Prepares and delivers training in research ethics and regulation to help staff and scientists better prepare for the complex and evolving ethical and regulatory clinical trial environment in which they work, including training in:
  • ICH Good Clinical Practice Guidelines.
  • Health Canada, Tri-Council Policy Statement and other Canadian regulatory requirements.
  • FDA, OHRP and other US regulatory requirements.
  • Helsinki Declaration, CIOMS and other international guidelines.
  • Specialized topics of particular importance to your institution.
Click here for a fuller description of this course.

In addition:

  • Acts as expert ethics advisor on Data and Safety Monitoring Boards and other study review committees.
  • Reviews proposed trial protocols to identify and describe potential ethical difficulties and provide appropriate strategies to resolve problems.
  • Carries out background research on challenging or recurring research issues and proposes policy options for dealing with them.

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