Avoid Clinical Trial Liability Lawsuits Improving Your Informed Consent Practices

Held Nov. 17, 2009

Lawsuits over the informed consent process are an unfortunate downside of clinical trials. But there are proven ways to minimize your risk. Learn about them from an expert at …

Informed consent problems never seem to go away. In fact informed consent lawsuits are on the rise.

That’s why FDAnews has invited a legal expert to explain informed consent ― in simple English that anyone can relate to. You’ll discover:

  • Top 5 elements missing from informed consent forms
  • Risks you must identify on the informed consent form ― what has to be included, what may be left out
  • Best practices for reviewing the informed consent form with trial subjects
  • The right person and the wrong person to conduct the informed consent reviewing
  • Risks and concerns of the “teach-back” trend
  • How to disclose financial interests of parties in the informed consent process
  • Ensure site-by-site consistency with the informed consent process
  • And much more!

Lawyer Mark Rodgers, an expert on legal issues in life sciences and healthcare, demonstrates how to perform successful risk assessments of your informed consent documents. You’ll learn how plaintiff’s lawyers think and the issues they might sue over ... best practices to protect yourself and patients ... practical precautions that reduce your liability long before a clinical trial begins.

This fact-packed 90-minute audio CD/Transcript is the perfect learning vehicle for busy professionals. You can attend from the privacy of your desk, listen to the presentation and ask questions by email. And you can count on getting answers by the time you log off.

Even better, use a conference room and invite your colleagues and staff. As many personnel may listen as you want, for one low registration fee. Just make sure all are at the same company location.

  • Clinical project specialists
  • Clinical research associates
  • Clinical quality assurance professionals
  • Regulatory/legislative affairs professionals
  • Compliance officers
  • Executive management
  • Study research coordinators
  • Physicians/chief medical officers
  • Clinical portfolio management
  • Risk management specialists

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Mark Rodgers is a member of The Rogers Law Firm's healthcare, corporate and international practice groups, specializing in life sciences, healthcare and corporate contractual matters, regulatory compliance, and fraud and abuse investigations. He has published and lectured extensively on legal issues in the life sciences and healthcare industries, and is co-editor of The Boston Health Law Reporter.

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