Risk Management Video Series

Clinical Trials

• Navigating the Clinical Trial Process

  In this video, we begin to explore why a clinical trial may be required and how to navigate through the clinical trial process. This video focuses on FDA regulations. Future videos delve into the clinical trial process as regulated by Health Canada, the Medicines and Healthcare products Regulatory Agency, and the relevant regulations in EU and EEA countries. This video sets the stage for our next segment on the products liability implications of clinical trials.

• Products Liability

  This video begins with a quick overview of products liability law as it applies to the life sciences industry then a discussion of how products liability may become an issue for those running clinical trials, and lastly, what you can do to reduce your exposure to liability.

• The Informed Consent Process

  Part three, we review the informed consent process. If you are ready to start phase one of your clinical trial, you might begin with subject recruitment through advertising. Once you have a group of individuals who are interested in participating in your clinical trial, this is where the informed consent process begins.

• Clinical Trial Agreement

  This video discusses the importance of the clinical trial agreement (CTA), which is essential for outlining the roles, responsibilities, and obligations of all parties involved to ensure regulatory compliance and patient safety.

• Vetting Your Institutional Review Board (IRB)

  Part 5 of this clinical trial series focused on the critical topic of vetting your Institutional Review Board or IRB. Ensuring your IRB is appropriately qualified and prepared is essential for mitigating risks in your clinical trials. This video will cover questions like: What is an IRB? Why is IRB oversight crucial for clinical trials? And how can you vet your IRB to ensure compliance with regulatory requirements?