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Phase III clinical trials require strict compliance with privacy and data protection laws across multiple jurisdictions, including GDPR obligations, local authorizations, and ethics committee oversight. The article outlines practical strategies such as the “funnel approach” to harmonize global frameworks, manage cross-border transfers, appoint Data Protection Officers, and ensure proper informed consent documentation. It also emphasizes the need for local representatives, jurisdiction-specific formalities, and standardized templates to maintain compliance and avoid delays in global studies.

Our latest analysis: U.S. vs EU—AI regulation shaping healthcare’s future.

China’s data protection regulations play a crucial role in clinical trials, requiring sponsors and researchers to comply with multiple laws, including the PIPL, GCP-2020, and cross-border data transfer rules. Unlike other jurisdictions, China imposes strict consent requirements, risk assessments, and regulatory filings, making compliance a key factor when selecting trial locations and managing participant data.

ICH-GCP and GDPR are vital for clinical trials, setting standards for participant protection and data integrity, with distinct focuses and enforcement approaches.