Change of Terms
After a clinical trial agreement has been signed and awarded, Stanford or the sponsor may wish to make changes to the terms and conditions of the original agreement. In most cases, this requires that both parties agree to and sign an amendment to the original agreement that specifically states the change to the language of the contract and the effective date of the change. This requires negotiation and signature by an Institutional Official for Stanford and an authorized individual from the sponsor or Clinical Research Organization (CRO).
Sponsors may also request that the terms and conditions of an existing agreement be changed to reflect a change in the sponsor’s policy or practice, in CRO, or in other material terms of the Agreement. Stanford may request that a contract be amended if a Principal Investigator assigned to the study leaves Stanford, for example, or some other change in policy or circumstances requires an amendment to an existing agreement.
If there is no change to the original budget, a change of the terms of an agreement does not require review by a Clinical Trial Research Process Manager (CT RPM) or Cancer Clinical Trials Office (CCTO) Financial Analyst. These amendments are negotiated and signed by a Clinical Trial Contract Officer (CT CO) at Clinical Trial Research Management Group (CT RMG).
How to Process a Change to the Terms of an Agreement
- If a sponsor sends a proposed contract amendment to a department, the department should send the amendment document and any correspondence related to the amendment to RMG_CT_Intake@stanford.edu. For Cancer Studies, amendment requests should be sent to firstname.lastname@example.org.
- Reference the SPO number on ALL correspondence regarding the amendment.
- CT RMG or CCTO will assign the request to a Contract Officer to review the original contract and the amendment.
- The Contract Officer will check the original Clinical Trial Agreement to determine whether the proposed amendment is acceptable under Stanford policy. If it is acceptable, the Contract Officer will sign the amendment and route it to the PI for signature.
- After the Amendment is executed by all parties, the Contract Officer will issue an Award Approval Notification (AAN) describing the change to the terms.
- The AAN is routed to the department and Office of Research Administration (ORA) to issue a Notice of Award (NOA).