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Page 2
Summary of Investigator 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 |