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Compliance In Focus
Posted by Jaime Wynbrandt on Mon, Feb 1, 2016

Study Closure and Final Sponsor Report

We have all had sites that close prior to the study actually being completed. It is always asked if the site’s Study_Closure_and_Final_Sponsor_ReportIRB allows them to close the study and submit the Sponsor’s final report when the study is completed or if the study needs to remain open at the site to allow the final report to be received by the IRB.

If the study needs to remain open with the IRB, this can become time consuming and costly if the study completion is several years away.  The site would need to submit for Continuing Review each year until the Sponsor’s final report is received.

Recently, a site closed the study with their IRB following their close-out monitoring visit. When the Sponsor’s final report came out six months later the site was unable to submit the report to their IRB as they would no longer accept the submission for a closed study. As a monitor, I wondered if this was okay and what, if any, implications this would have.

What do the regulations say?

  • In the case of a significant risk device, the sponsor shall submit a final report to all the IRB's and participating investigators within 6 months after completion or termination. (21 CFR 812.150(b)(7))
  • No requirements in the regulations for Sites

What does FDA say?

We contacted the FDA at the email address where they accept and answer questions to ask them this very question. (gcp.questions@fda.hhs.gov).  The following prompt response was received from Sheila Brown, RN, MS, Policy Analyst, Office of Good Clinical Practice.

FDA regulations or guidance do not specifically address this situation. The IRB's SOPs should indicate what documentation/report is to be submitted at what time period, and shared with the investigators in the information sent when approving the study. This IRB has indicated that they will consider the study closed when the final report for this site is submitted, and not accept any further documentation. You have a choice to either keep the study open for that site until the entire study is completed, or to submit a final report for the single study completed at that site, and close the study at that single site.  If you choose to close this single site with a final site report when follow-up is completed, the Sponsor may still send the final study report for the completed IDE study to the IRB. The Sponsor may want to send it with a return receipt requested, or other method to document that the submission was received, which fulfills their responsibility as a Sponsor to provide the report per 812.150(b)(7).

Ultimately, in this scenario, the Sponsor should still submit the final report to the site’s IRB even if the IRB will not accept the submission.

What are your experiences with this? We look forward to hearing them.

Research Coordinator Support blog CTA

photo credit: reflections via photopin (license)

Topics: FDA, IRB, Sponsor Report, Study Closure

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