Hi Richard, Thanks a lot for your input. Although it's an IDE but under CBER, and involves Stem Cell Transplant for cancer treatment. However, I like your idea of communicating the two aspects independently which will be easy for reviewers to go through.
Thanks again, have a good day!
Israr
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Israr Ansari PhD, MS, RAC
Sr. Scientist - Clinical Trials
University of Wisconsin-Madison
Madison, WI.
USA
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Original Message:
Sent: 24-Aug-2021 04:01
From: Richard Vincins
Subject: Combining IDE report with minor changes in the protocol
Good day Israr,
The IDE process can be a bit complicated so being able to answer your inquiry succinctly might be difficult. It sound from the information provided this might be acceptable, but also trying to understand what type of reporting you are referring to in the post. Generally, if you are making protocol changes, these would be identified and reported based on the changes being made. When dealing with IDEs, I personally prefer to keep things separate based on what is being done. If you submit too many different things to reviewers, it can get a little confusing and raises more questions than would be expected. Also being able to answer depends on what point you are in the IDE process, type of device, and type of study you are doing, so might seek some external help in this regard.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 23-Aug-2021 11:15
From: Israrul Ansari
Subject: Combining IDE report with minor changes in the protocol
Hello everyone,
I'm exploring to submit a combined IDE report (immunotherapy) and a couple of minor changes in the protocol together. Briefly, the IDE report would involve submitting safety reports on few subjects, and the protocol changes would mainly involve minor changes. Still, they will include changes in the study duration, changes in the testing laboratory, and a day or two adjustments in the timing of clinical assessments due to scheduling conflicts. Any help will be great; thanks in advance.
Israr
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Israr Ansari PhD, MS, RAC
Sr. Scientist - Clinical Trials
University of Wisconsin-Madison
Madison, WI.
USA
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