Consent template designed for global clinical trials. Includes provisions for cross-border data transfer, local regulatory compliance, and multi-language considerations.
The International Multi-Site consent template addresses the complex regulatory and ethical requirements of global clinical research. It provides a framework that can be adapted to meet local requirements while maintaining consistency across participating sites and countries.
With thirteen sections, this comprehensive template covers introduction, global study overview, local site information, study procedures, risks and safety monitoring, benefits, cross-border data transfer provisions, privacy protections under multiple regulatory frameworks, compensation, voluntary participation, local emergency contacts, sponsor contacts, and IRB/ethics committee information.
The cross-border data transfer section is particularly detailed, explaining GDPR implications for European participants, standard contractual clauses, and how data will flow between countries. This transparency is essential for compliance and for building participant trust in multinational studies.
This template serves as a master consent that can be localized for each participating country while maintaining the core elements required by the study sponsor and international regulations.
This is a preview of the complete consent form experience participants will see.
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Signature Area
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This template includes provisions for cross-border data transfer that comply with GDPR requirements for European participants.
Addresses privacy protections under multiple regulatory frameworks and provides flexibility for local adaptations.