Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​

Dear all,

Your guidance for my question will be much appreciated.

Section 3.5.5 of the guidance eCTD technical conformance guide indicates that IND safety reports should be provided in section 5.3 of the eCTD.

We have currently a clinical study filed under CTD section 5.3.5.1 (US IND). For an IND safety report (SUSAR), it is not clear for us in which subsection of 5.3 of the eCTD shall we file such report. Is it ok if we create a sub node under section 16.3.1 of the CSR for this purpose?

Thanks a lot for your help!

You would want to first create the study tagging file in 5.3.5.1 and then create a sub node for the SUSAR and place it there.  I would not create a sub node under 16.3.1 and place the SUSAR there.

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Mary Waters
Hartmann Willner
Washington DC
United States
mlwaters@hw-fda.com
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Original Message:
Sent: 05-Oct-2017 11:56
From: Anonymous Member
Subject: IND Safety Report Question

This message was posted by a user wishing to remain anonymous

​

Dear all,

Your guidance for my question will be much appreciated.

Section 3.5.5 of the guidance eCTD technical conformance guide indicates that IND safety reports should be provided in section 5.3 of the eCTD.

We have currently a clinical study filed under CTD section 5.3.5.1 (US IND). For an IND safety report (SUSAR), it is not clear for us in which subsection of 5.3 of the eCTD shall we file such report. Is it ok if we create a sub node under section 16.3.1 of the CSR for this purpose?

Thanks a lot for your help!