Principal investigator

The principal investigator leads the site team, protects subjects and makes sure the CIP is followed. Whether the role sits with a person or an institution can depend on national law.

qualified person responsible for conducting the clinical investigation (3.8) at an investigation site (3.28) Note 1 to entry: If a clinical investigation is conducted by a team of individuals at an investigation site, the principal investigator is responsible for leading the team. Note 2 to entry: Whether this is the responsibility of an individual or an institution can depend on national regulations.

ISO 14155:2020, clause 3.39