ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems vs GDPR

What is the difference between ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems and GDPR?

ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems is a other framework applying in International (ICH), with 22 controls across 7 domains. GDPR is a privacy framework applying in the European Union, with 40 controls across 4 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.

ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems22 controls

GDPR40 controls

Questions people ask about ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems and GDPR

What is the difference between ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems and GDPR?

ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems has 22 controls while GDPR has 40 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.

Do I need both ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems and GDPR?

Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems and GDPR so you can identify shared requirements and avoid duplicate effort.

How do ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems and GDPR controls map to each other?

Our platform maps controls between ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems and GDPR at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.

Which framework should I implement first, ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems or GDPR?

The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.

Each framework on its own