Obtaining Consent in International Clinical Trials - Webinar CD/Transcript

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Obtaining Consent in International Clinical Trials: Key Considerations

More than 60 percent of clinical studies submitted to CDER contain data from foreign study sites.

Researchers need to be aware of the cultural differences, legal and regulatory requirements — and international guidelines — dictating principles for obtaining informed consent.

Get prepared to adapt global informed consent templates to local country requirements.

Kristen Henderson, legal director at Quintiles, will help attendees navigate the international informed consent landscape with practical advice about:

  • Cultural differences
  • Regulatory environment factors (Case Study — India’s requirement for Audio-Visual Consent)
  • Patient Populations (e.g., Pediatric, Incapacitated, Vulnerable Subjects)
  • e-Consent and other Data Protection/Confidentiality Considerations
  • Data sharing initiatives

Order today to get prepared for conducting international clinical trials.

  • Clinical project specialists
  • Clinical research associates
  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Strategic planning and business development staff
  • Study monitors
  • Study research coordinators
  • Study sponsors
  • Training personnel

Kristen M. Henderson is a Legal Director specializing in regulatory affairs and privacy at Quintiles, the largest biopharmaceutical services provider in the world.  For nearly a decade, Kristen has provided practical guidance to Quintiles’ employees and customers on legal-regulatory and privacy matters, principally in the context of international clinical research.  Kristen serves as the subject matter expert on informed consent matters within Quintiles’ Office of General Counsel, as well as primary legal counsel for Quintiles’ Health Engagement and Communications team.