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Dear all,
Do you differentiate artifacts for submission of Initial & Substantial Ammendments vs simple notifications, both in Regulatory and IRB/IECs?
We are filing Initial submission & Substantial Amendments under 03.01.01 or 04.01.01.
But we have doubts with simple notifications such as notification of first patient in, start of trial, study specific memos.
In Zone 3, Regulatory we are filing in 03.03.01 Notification of Safety or Trial Information and in Zone 4 in 04.04.01 Relevant Correspondence.But the truth is that in the definition of artifact 03.03.01 Notification of Safety or Trial Information, only relates to Safety documents.
Not sure if 03.03.02 Regulatory Progress Report would be an option. We file here only Annual Progress Report.
Many thanks in advance for your feedback
KRs
Chelo
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