Regulatory Open Forum

Here is the question: The Sponsor has a US IND, the planned clinical trial was not initiated, but there are other studies ongoing in country X, the sponsor reported 2 SUSAR report of the foreign study to the US IND and leads to the clinical hold of the US IND, in this situation, does the sponsor needs to continue report the foreign study SUSAR (follow-up report) to the US IND? and does the sponsor need to report new SUSARs (initial report) to the clinical hold US IND? Thanks a lot for the input here!

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Ziqi Zhang
Clinical Consultant
Raleigh NC
United States
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Hi Ziqi - although on clinical hold, the IND is still active and safety information, including SUSARs and annual reports, still need to be submitted to the IND.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 31-Jan-2023 11:19
From: Ziqi Zhang
Subject: SUSAR reporting during clinical hold period

Here is the question: The Sponsor has a US IND, the planned clinical trial was not initiated, but there are other studies ongoing in country X, the sponsor reported 2 SUSAR report of the foreign study to the US IND and leads to the clinical hold of the US IND, in this situation, does the sponsor needs to continue report the foreign study SUSAR (follow-up report) to the US IND? and does the sponsor need to report new SUSARs (initial report) to the clinical hold US IND? Thanks a lot for the input here!

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Ziqi Zhang
Clinical Consultant
Raleigh NC
United States
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