Obtaining Consent in International Clinical Research: Key Considerations

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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.

This management report will help trial sponsors and investigators navigate the international informed consent landscape with practical advice about:

  • How cultural differences in different countries affect obtaining informed consent

  • 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 Obtaining Consent in International Clinical Research today to get prepared for conducting international clinical trials.

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  • 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

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