Principal investigator role

Definition

Principal investigator (PI) is an individual who actually conducts a study (i.e. under whose immediate direction the drug is dispensed to a subject). If an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.

FDA Expectations of Clinical Investigators

The FDA requires the investigator to adhere to the code of federal regulations and to have complete knowledge and understanding of the clinical investigators regulations and responsibilities.

Responsibilities of Principal Investigator

• Principal investigators are in charge and can be held accountable if required.
• They are required to control the investigational drug.
• They are responsible for record keeping and retention.
• They have to maintain adequate records of the disposition of the drug.
• They are responsible for accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
• They are not permitted to delegate their general responsibilities to Contract Research Organizations (CRO) or site management organizations, subinvestigators, or study staff.