If the error was a clerical error that does not impact safety at all, then you can follow the process that you describe. At the time of the next "substantial" amendment to be submitted to FDA you will have skipped an amendment number, so naturally you would provide an explanation in the cover letter.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States
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Original Message:
Sent: 06-May-2021 16:26
From: Anonymous Member
Subject: IND Protocol Administrative Changes
This message was posted by a user wishing to remain anonymous
How do you handle an editorial correction (i.e. correct information that was missed in previous amendment) in a protocol? An amendment was submitted to FDA but the error was caught before IRB submission. Do you make the change (update protocol version) submit to IRB and then next time you have an amendment call it out in the cover letter?