Principal investigator (PI)
In Roles & organizations
The principal investigator is the person responsible for the conduct of a clinical trial at one site. The PI must be qualified by education, training, and experience, and is accountable for participant safety, protocol compliance, and the accuracy of the data from that site. Tasks can be delegated to trained staff, but the responsibility cannot.
Example
A PI signs the delegation of authority log to authorize a coordinator to take consent, and reviews and signs off laboratory results that fall outside the normal range.
Common questions
- Can the principal investigator delegate their duties?
- They can delegate specific tasks to suitably qualified staff and must record this on the delegation log, but they cannot delegate overall responsibility for the trial at their site.
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