Clinical Trial Closeout
The standard Study Closeout process begins when the sponsor confirms with the study team that all work on the clinical trial has been completed and the relationship between Stanford and the Sponsor on the project has ended.
The Office of Sponsored Research (OSR) Post Award Team Accountant assigned to your department manages the Closeout process at Stanford and will provide the department award manager with a Checklist to Closeout a clinical trial.
No Cost Extension (NCX)
When a Stanford department receives an automated Closeout notice from OSR, but the Study has not yet ended or is not ready to Closeout, submit a NCX Central Office Request Form in the SeRA system.
Most clinical trial agreements (CTA) do not have a specified end date stated in the contract. The agreements typically state that the study will terminate when it has been completed at the site or the sponsor notifies the site in writing to cease enrollment and all study activities.
When both the sponsor and study team agree that all work on the clinical trial, including all financial obligations, has been completed before the Award end date, the study team or department should request an Early Termination by submitting a Clinical Trial Research Management Group (CT RMG) Early Termination form to the CT RMG Intake Team.
If a Stanford department receives a Notice of Termination, the department should submit the notice to CT RMG to update the SeRA (Stanford Electronic Research Administration) system record to reflect the correct end date of the Study.
An Early Termination and a Checklist to Closeout a clinical trial will be required by the Office of Sponsored Research (OSR) Post Award Team Accountant prior to processing an Early Closeout.
How to Request an Early Termination
- Checks the CTA to determine the process for termination required by the contract;
- Changes the end date in SeRA to the requested end date or the date in the Notice of Termination; and
- Issues an Early Termination Notice of Award (NOA).
The Department works with Office of Sponsored Research (OSR) Post Award to close the study account.
FAQ’s Early Termination / No Cost Extension for Industry or Investigator Initiated Sponsored Clinical Trials
1. Invoicing has been completed but we’re waiting to receive payment. Can I request the account (PTA) be closed?
Yes. If all invoicing has been completed, the close-out process with OSR can still move forward to changing the award status to On Hold to prevent further charges to process. Funds can be received after the close-out process.
Award close-out also prompts OSR Collections to pursue any hold back payments.
2. Should the IRB protocol stay open if the study account (PTA) is open?
If there are patients being seen or the sponsor has not closed the study, then the IRB protocol must remain open. But the study account only needs to remain open in order for expenses to post (e.g., from the hospital) or if invoices still need to be processed thru CRISP. In those cases, the IRB protocol does not need to be open.
3. As a Research Administrator, how do I know if I need to request an early closeout? And if so, how do I do that?
Check with the PI/Study Team to see if the study and IRB protocol are still open. If IRB protocol is closed/final report submitted, and all invoicing has been completed, then you should request an early termination by following the process outlined above.
4. What if the PI is still doing data analysis and the IRB protocol is closed. Do I need a NCX?
If the IRB protocol is closed, the PTA only needs to remain open if there will be additional charges (non-human subject) for the data analysis or invoicing. Otherwise, a NCX is not needed.
5. Where can I find information about how to close an IRB protocol?
On the Research Compliance Website: https://researchcompliance.stanford.edu/panels/hs/forms/forms-templates/faqs#close
6. Stanford is part of a multi-site Clinical Trial, and Stanford’s portion of the CT is now completed. However, if the sponsor wants to keep the study open until ALL sites are complete (e.g., sponsor won’t do the data lock until all sites are complete), does Stanford’s IRB need to remain open until the sponsor closes the entire study?
Yes, the IRB will need to remain open until the Sponsor closes the protocol and will continue to go through continuing review (renewal). Generally IRB protocols remain open while investigators are still collecting or reviewing identifiable data. Annual IRB Renewal Fees will continue to be charged until the Stanford protocol is closed.