We have a situation where we need to close a study site because they do not have the resources to perform the study anymore (coordinator has left and PI is not interested in the study anymore and he is leaving the institution). The site has not enrolled anyone into the study.

1. Do we as the sponsor have authority to terminate a site via a written letter to the site? Or does the notification need to come from the site/investigator themselves where they indicate that they want to withdraw as a site? Our current CTA language includes the following:
"Institution and Investigator may terminate this Agreement immediately upon written notice to Sponsor if: Investigator is unable or unwilling to continue to serve in his/her capacity for the Study and Institutionís efforts to replace the Investigator have continued without finding such replacement for more than thirty (30) days from the date that Institution so notified Sponsor of such inability or unwillingness." We also have this language: Either Party may terminate this Agreement upon written notice if the other Party materially breaches any provision of this Agreement, which breach continues and is not remedied within [thirty (30)] calendar days after the date of receipt of such notice.

2. Does a formal closeout visit need to be performed? Nothing was done at the site and no patients were enrolled. If yes, how would this be done, if there is no coordinator?

Thank you,