Obtaining Consent in International Clinical Trials - Webinar CD/Transcript
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.