Principal Investigator (PI) Changes
If a Principal Investigator (PI) for an industry-sponsored clinical trial intends to resign from Stanford or will be away for an extended period (3 months or more), the PI must request approval from the sponsor to appoint a permanent replacement or an interim PI to manage the study. Stanford confirms the formal transfer through an amendment to the Clinical Trial Agreement (CTA).
How to Request a PI Change
The existing PI should identify an eligible colleague who will assume responsibility for the study while the PI is absent from Stanford. To be eligible, the new PI must be qualified by education, training, and experience to perform required tasks as a Principal Investigator and should provide evidence of such qualifications through an up-to-date curriculum vitae (CV) and/or other relevant documentation the sponsor requests. All PIs must complete Good Clinical Practice (GCP) as a part of Human Subjects training prior to assuming responsibility for a clinical trial. The sponsor must approve the new PI in accordance with the terms of the CTA.
The existing PI or department notifies CT RMG of the dates of intended departure and return (if applicable) and provides all of the following:
- CTA amendment request, including any correspondence with the sponsor approving the PI Change
- PI Waiver with required supporting documents (if applicable)
In addition, the PI or department needs to submit a change of Protocol Director (PD) to the Institutional Review Board (IRB). CT RMG reviews the required documentation, verifies completion of training and requests a contract amendment from the sponsor to formally change the PI name permanently or temporarily. Before signing the amendment, RMG will confirm IRB approval of the change in PD. After receiving a fully-executed amendment from the sponsor, CT RMG issues an Award Approval Notification (AAN) through the SeRA (Stanford Electronic Research Administration) system.