The regulation is vague on your question, but based on the description in 21 CFR 312.30(c) you can count the 30 days from when the investigator is eligible to receive drug. I can tell you that we struggle all the time with the definition of when an investigator is added, or a study initiated, etc. Generally, we use eligibility to receive drug as the key time point.
Note in 312.30(e) that new investigators can be combined and submitted monthly.
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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 18-Sep-2018 09:09
From: Anonymous Member
Subject: New Investigator Submissions
This message was posted by a user wishing to remain anonymous
Dear Community-
21 CFR 312.30(c) states that the sponsor shall notify the FDA of the new investigator within 30 days of the investigator being added. What triggers the start of the 30 days - is it site activation, first subject to consent or shipping drug?
Thank you for you for your guidance!