Hello Hua,
Generally speaking, it is required that
applicable clinical trials be registered
within 21 days of the first patient enrollment.
Here is a checklist to determine if your study is an "applicable" clinical trial requiring registration. Technically, phase I trials are not required to be registered (so Box A would technically be correct). However, I highly recommend registering the phase I trial for many reasons including transparency, patient recruitment, etc. Additionally, ICMJE standards are that a trial must be registered in order to be considered for publication (
see their website here). I would note that ICMJE timing requirements for registration are more stringent than CT.gov; they require registration
at or before the first patient enrollment.
I have found the ClinicalTrials.gov FAQ page to be very helpful (
see FAQ page here).
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Susie Hargrove JD
Regulatory Affairs JD
Horseshoe Bay TX
United States
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Original Message:
Sent: 05-Oct-2022 18:50
From: Hua Jin
Subject: 3674 form Section 9, B or C for FIH IND
Hello all,
For phase I IND submission to the FDA, should one check box B or box C for the 3674 form section 9.
Box A is checked if the clinical trial is not subject to the registration requirements
Box B is checked if the registration requirements do not apply at the time of the submission of the IND
Box C is checked if the study has been registered
Thank you.
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Hua Jin
United States
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