World of Compliance Module

Statement of Investigator, Form FDA 1572

The investigator must provide the sponsor with a completed, signed Statement of Investigator, Form FDA 1572. The clinical investigator must abide by FDA regulations in the conduct of the trial.

Clinical investigators commit to:

• Provide names of sub-investigators
• Follow current protocol
• Personally conduct or supervise the investigation
• Ensure all persons assisting in the study are informed of their obligations
• Inform subjects about investigational drugs and ensure informed consent and IRB review, approval and reporting
• Report adverse events to the sponsor
• Inform associates in conduct of the study
• Maintain adequate and accurate records, and ensure the records are available for inspection
• Ensure initial and continuing review by IRB, report all changes to research and unanticipated problems involving risks to subjects and not make changes without IRB approval except where necessary to eliminate immediate hazards to subjects
• Comply with other requirements