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 |
FDA, US Food and Drug Administration; IRB, institutional review board.