Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi Community, 

FDA has approved our IDE, and IRB has not yet. When FDA approved the IDE, they have also provided a list of recommendation for editorial changes on the clinical protocol, separately. When there are significant amount of changes to the clinical protocol (maybe 1 or two changes that are really considered significant change but many small little editorial types), would one 30-day supplement be the easiest way to approach this?

This message was posted by a user wishing to remain anonymous

FDA has a guidance on what changes have to be reported during a clinical study and when. Depending on the significance, they either require approval in an IDE Supplement, or FDA has to be notified within 5 days of implementation or the change has to be included in the annual report. If you have any changes that require approval per a supplement, it probably makes sense to include them all in that supplement. The guidance is attached in case you have not seen it.
Original Message:
Sent: 29-Jun-2018 17:19
From: Anonymous Member
Subject: Approved IDE - Modification on Clinical Protocol

This message was posted by a user wishing to remain anonymous

Hi Community,

FDA has approved our IDE, and IRB has not yet. When FDA approved the IDE, they have also provided a list of recommendation for editorial changes on the clinical protocol, separately. When there are significant amount of changes to the clinical protocol (maybe 1 or two changes that are really considered significant change but many small little editorial types), would one 30-day supplement be the easiest way to approach this?