ISO 14155:2026 is the governing standard for Good Clinical Practice (GCP) in medical device clinical investigations. Sponsor responsibilities now sit in Clause 9. Principal investigator responsibilities are in Clause 10. The 2026 edition introduced substantive new requirements around study governance, the estimand framework, adverse event categorization, and risk management integration.

This checklist, written by Páll Jóhannesson, covers both sets of obligations across pre-study and ongoing study phases, with section-level notes on requirements that commonly surface as audit findings.