Sponsor Changes

When an industry sponsor or contract research organization (CRO) notifies Stanford that it has transferred an active clinical trial to a new sponsor or CRO, the CT Team must amend the existing clinical trial agreement (CTA) to reflect the new parties to the agreement. The CT Team also updates the SeRA (Stanford Electronic Research Administration) system to ensure that future invoices are sent to the correct sponsor. Other types of Sponsor Changes include changes to the sponsor’s contact information or a change of the sponsor’s name only.

The purpose of the Sponsor Change is to ensure:

• The CTA names the correct legal entity,
• No conflict of interest exists between the new sponsor and the Principal Investigator (PI) and anyone on the study team, and
• Stanford sends invoices and legal notifications to the correct entity.

When a PI or department receives a notification of Sponsor Change from the current sponsor, the PI or department must:

1. Notify ORO of the Sponsor Change. The new sponsor must be
   1.  named in the IRB revision application as well as the Informed Consent Form.
2. complete a Conflict of Interest certification in the Outside Professional Activities System (OPACS) referencing the new sponsor name.
3. Submit the following to CT Intake:
   1. Sponsor notification letter and all correspondence relating to the Sponsor Change;
   2. Sponsor Change Form
   3. IRB approval of the Sponsor Change; and
   4. Confirmation of Conflict of Interest certification.

If the CT Team receives a Sponsor Change notification, the CT Team sends the notification to the appropriate PI and department and requests the documentation noted above.

After receiving notice of a Sponsor Change

1. The CT Team Intake reviews the required Sponsor Change Documentation and if necessary, requests additional information from the department, PI, or sponsor.
2. CT CO processes an amendment to the existing CTA to reflect the Sponsor Change information.
3. CT CO processes the Sponsor Change in SeRA as a CTA amendment so that OSR Post-Award updates the financial system to reflect the Sponsor Change for future invoices.