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Thread: Terminating a Study Site

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  1. #1
    Forum Member
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    Jan 2023

    Terminating a Study Site

    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 Institution’s 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,

  2. #2
    Dear Hello123, hopefully this reply is still of interest given the 2 months elapsed since your post.
    1 - In my opinion: yes, as sponsor you have the right to terminate the contract with this site. How to phrase this best and which contract § to cite should be aligned with your legal department. At least you could ask how the instituation intends to tackle the situation (perhaps they have an alternative PI and other staff to take over).
    2 - I assume there was an official initiation visit. The site may have investigational product at their disposal. So, yes, a close out should be done. Even if the site did not include subjects, they were "open for recruitment". Depending on what has been done beforehand (e.g. return of investigational product) it may be an option to do the close out remotely. You need to check the specific case. You also want to ensure that any documentation provided (like an Investigators Brochure) will be kept confidential. In my opinion you can also perform a short close out visit with another nomimee of the site who has access to e.g. study material or documents.

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