Good question! I found a requirement that the IRB be immediately notified in this
Guidance, at section 3.1 (Establishment and Operation of Clinical Trial Data Monitoring Committees).
Since you might expect the new site has different procedures, and different staff that may need different training, I recommend you contact your manager at FDA and let them know what's involved in this change, and follow their directions.
FDA is very flexible with changes during the pandemic, as per
this guidance, Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency so I believe they will be helpful.
Also, review the changes discussed here, in this
Information Sheet. Good luck!
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Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.
Maryland
United States
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Original Message:
Sent: 02-Feb-2022 08:27
From: Anonymous Member
Subject: IDE Clinical Trial
This message was posted by a user wishing to remain anonymous
Please let me know the regulatory implications of shutting down an IDE site that has not enrolled any patients and replacing it with another qualifying site. Is it sufficient to include this change in the annual report to FDA ? The FDA only restricted the total number of sites in the IDE .
Thank you