Principal Investigator (PI) Changes

If a Principal Investigator (PI) for an industry-sponsored clinical trial intends to resign from Stanford or will be away or disengage from the study 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 Stanford’s PI Training as well as 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.  [See links on sidebar for more information on required training].

Instructions:

The existing PI or department sends an email requesting the PI change to the CT Intake team at  ct_rmg_intake@stanford.edu.

The email must include:

  • SPO and project title
  • Dates of intended departure and return (if applicable) of current PI
  • CTA Amendment for PI Change or correspondence from sponsor
  • PI Waiver for replacement PI (if applicable) with required supporting documents


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 replacement PI training and initiates an award amendment transaction in SeRA.  The amendment is assigned to a CT Contract Officer for review and execution. 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.

Departments are reminded that if this is a temporary/interim change in PI, the department will need to request another PI change from CT RMG when the original PI returns to the project.