Dear Vasundhara -
Qi Cheng is correct, you normally don't send FDA copies of any "memos." And I may add that except for certain safety reports that meet the requirements for submission by the sponsor to FDA under an IND (or IDE), it is incredibly rare to include any of the communications between the sponsor and investigators in your FDA regulatory submissions. Even if you send a protocol amendment to investigators (and yes, a copy of that amendment itself goes to FDA eventually), the cover memo to the investigator would not need to accompany the protocol amendment copy that is sent to FDA. Keep all those communications on file, of course, should an inspector wish to determine if the sponsor is adequately monitoring the study and otherwise assuring that investigators are following the investigational plan as appropriate.
Best regards,
Jan
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Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
Consultant and
VP of Regulatory Affairs and Quality
Global Regulatory Partners, Inc.
United States
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Original Message:
Sent: 24-Jul-2020 08:59
From: Vasundhara Pathak
Subject: Investigators Memo
Hello All,
I have a query. Do you need to submit to the FDA all types of memos sent to study investigators? or Only memo related urgent safety measures (USM) need to be submitted to FDA?
Please advice!
Thanks