As the clinical trial award project end date approaches, the Principal Investigator (PI) and study team should assess whether they can complete the project work within the remaining time. If the project requires additional time, the study team should request a No-Cost Extension (NCX) 30-60 days prior to the project end date. The Clinical Trial Contract Officer (CT CO) may issue an administrative NCX in SeRA without sponsor approval if the clinical trial agreement (CTA) does not specify an end date. If the CTA specifies an end date, CT RMG first must request written permission from the sponsor in order to extend the CTA term.
Department finance and budget personnel request an NCX by submitting a Central Office Request Form in the SeRA System. When completing the request form, indicate the NCX is for a clinical trial and should be routed to CT RMG for processing.
CT CO reviews the CTA to determine whether it specifies an end date. The following steps are dependent on the CTA terms:
- if the CTA does not specify an end date the CT CO issues an NCX in SeRA with the revised end date; or
- if the CTA specifies an end date, the CT CO contacts the sponsor to request an amendment to the CTA. After the sponsor and CT CO sign the amendment, the CT CO issues and NCX extending the project end date in SeRA.
Stanford Internal Policies: