Who is ultimately responsible for product accountability at the study site?

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Summary of Investigator Requirements and Responsibilities

Category	Requirements and Responsibilities
Principal investigator	•Anyone qualified by training to run the trial; a physician or dentist must be listed as a subinvestigator if the principal investigator is not a physician
	•Hire and train qualified individuals to run the trial
Subject safety	•Protect subjects from harm
	•Keep track of drugs and distribute only as specified in the protocol
	•Obtain informed consent
	•Ensure IRB approval
	•Keep careful records and maintain them for as long as the protocol dictates or at least 2 years
Reports	•Progress, safety, financial, and a final report to the study sponsor
	•Adverse events; serious adverse events must be reported immediately
	•Update financial disclosures if any circumstances change during the study
Form 1572	•Strictly adhere to the protocol
	•Directly supervise the study and take responsibility for study staff
	•Inform subjects of experimental nature of the drug products
	•Report adverse events and stay updated on the investigational brochure
	•Maintain records
	•Ensure IRB compliance
FDA inspections	•Ensure all records are complete and easily accessible by FDA
	•Send a written response within 15 business days if any violations are found
How to avoid violations	•Read all communications from the IRB
	•Hire experienced staff and verify their credentials
	•Train staff regularly
	•Check for conflicts of interest/financial disclosures regularly
	•Write efficient protocols or reduce inefficiencies or confusing portions of the protocol
	•Keep regulatory binders up to date and conduct continuing reviews
	•Meet with the team regularly
	•Conduct several dry runs to ensure the study will run smoothly
	•Regularly check data processes