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.
• An investigator is required to maintain investigation records for:
  • 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated.
  • 2 years after the investigation is discontinued and FDA is notified if no application is to be filed or if the application has not been approved for such indication.