How do I submit a change of Principal Investigator (PI)?
• Please provide confirmation from the sponsor that the change is acceptable and has been approved. The sponsor is required to select investigators under 21 CFR 312.53(a). • Provide a letter from the current PI, relinquishing responsibility for the study (if this is unavailable, please indicate that it is not available and why). • Provide a letter from the new PI requesting appointment as the new PI.
