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. There are 2 types of amendments: External and Internal
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:
- Change in Contract Terms and Conditions - 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 - How to Process a Change in PI: http://med.stanford.edu/rmg/clinical-trials/post-award-management/pi-changes.html
- Changes in Sponsor or CRO - How to Process a Change in Sponsor: http://med.stanford.edu/rmg/clinical-trials/post-award-management/sponsor-changes.html
- Budget Amendment - Protocol Amendment requires either an increase or decrease in funding or department-initiated change in budget.
How to Process a Budget Amendment
- The department of study team prepares a Budget Amendment Intake Packet
- Completed Budget Amendment Intake Form
- All relevant email correspondence
- All required documentation
- For non-cancer studies, department or study team submit packet by email to RMG_CT_Intake@stanford.edu. If the study budget was completed by CCTO, submit to CCTO as a REDCap request. Contact email@example.com for any questions.
- Reference the SPO number on ALL correspondence regarding the amendment.
- CT RMG or CCTO assigns the request to a Research Process Manager or CCTO Financial Analyst and a Clinical Trial Contract Officer (CT CO)
- CT RMG or CCTO checks the original Clinical Trial Agreement and budget and if required, requests SHC Coverage Analysis to update or revise the Billing Grid in the Workbook. PI approval of the revised coverage analysis (Billing Grid) is required for budget analysis and negotiation with sponsor.
- CT RMG or CCTO 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.
- If the sponsor requests a change to the terms of the agreement, a CT CO will review and negotiate the terms.
- After the parties have negotiated and approved an amendment, the CT CO will sign the amendment and issue an Award Approval Notification (AAN).
- 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.
- If changes are made to the CA Billing Grid, a new Final Approved CA Workbook will be sent by Ankura to the study team for submission to PFS.
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
- Details updated in SeRA for internal/administrative purposes only.
How to Process an Internal Amendment
If the CTA does not have a specified end date and study period needs to be updated in SeRA.
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.