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 Clinical Trial Research Management Group (CT RMG) must amend the existing clinical trial agreement (CTA) to reflect the new parties to the agreement. CT RMG 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.
How to Request a Sponsor Change
When a PI or department receives a notification of Sponsor Change from the current sponsor, the PI or department must:
- of the Sponsor Change. The new sponsor must be
- named in the IRB revision application as well as the Informed Consent Form.
- complete a Conflict of Interest certification in the Outside Professional Activities System (OPACS) referencing the new sponsor name.
- Submit the following to CT RMG Intake:
- Sponsor notification letter and all correspondence relating to the Sponsor Change;
- IRB approval of the Sponsor Change; and
- Confirmation of Conflict of Interest certification.
If CT RMG receives a Sponsor Change notification, CT RMG sends the notification to the appropriate PI and department and requests the documentation noted above.
After receiving notice of a Sponsor Change
- CT RMG Intake reviews the required Sponsor Change Documentation and if necessary, requests additional information from the department, PI, or sponsor.
- CT CO processes an amendment to the existing CTA to reflect the Sponsor Change information.
- 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.