Amendments

After a clinical trial agreement has been signed and awarded, Stanford or the sponsor may need to request changes to the budget or the terms of the original agreement. These changes need to be reflected in SeRA.

External Amendments

External amendments have the following characteristics:

  • Require signature by an Institutional Official for Stanford and an authorized individual from the sponsor or Clinical Research Organization (CRO)
  • May require negotiation
  • Require an effective date

External Amendments can result from:

  • Protocol Amendment – change in protocol requires a budget revision, either increase or decrease.
  • Revised terms and conditions to reflect a change in the sponsor’s policy or practice, in CRO, or other material terms of the Agreement.
  • Change in Principal Investigator

Internal or Administrative Amendments

Internal amendments have the following characteristics:

  • Do not require signature by an Institutional Official for Stanford nor an authorized individual from the sponsor or CRO
  • Negotiation not required

How to Process an External Amendment

  1. When a sponsor sends a proposed contract amendment to a department, the department sends the amendment document and any correspondence related to the amendment to RMG_CT_Intake@stanford.edu. For Cancer Studies, amendment requests are sent to ccto-intake@stanford.edu.
  2. Reference the SPO number on ALL correspondence regarding the amendment.
  3. CT RMG or CCTO assigns the request to a Contract Officer and/or Research Process Manager or CCTO Financial Analyst.
  4. CT RMG or CCTO checks the original Clinical Trial Agreement and budget and works with the study team to determine acceptability of the amendment funding. If the offered amount is not acceptable, the CT RPM or Financial Analyst negotiates the higher amount with the sponsor, with input from the study team.
  5. If the sponsor requests a change to the terms of the agreement, a Clinical Trial Contract Officer will review and negotiate the terms.
  6. After the parties have negotiated and approved an amendment, the Contract Officer will sign the amendment and issue an Award Approval Notification (AAN).
  7. CT RMG routes the AAN to the department and to Office of Sponsored Research (OSR) Post Award to issue a Notice of Award.  OSR changes the existing account to reflect amendments to the budget.

How to Process an Internal Amendment

No-Cost Extension

If the CTA does not have a specified end date and study period needs to be updated in SeRA.

Funding Increase

If the receipts from a clinical trial are at or near the awarded amount in SeRA, the study team needs to submit a Funding Increase request to CT RMG.  CT RMG issues an internal amendment that allows Sponsored Receivables Management to credit the study account with additional payments from the sponsor.