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Posted On: 08/23/2021 5:41:20 PM
Post# of 148925
Regarding Biomm's notes and the wait for the trials to start
This is the most fundamental post I've seen about it, but is secondhand info from the YMB. If I find the original post about contacting Biomm, I'll post it:
As for what the notes are, also from the YMB:
This is the most fundamental post I've seen about it, but is secondhand info from the YMB. If I find the original post about contacting Biomm, I'll post it:
Quote:
Jay2 days ago
Someone indicated that they got a message back from a representative at BIOMM indicating the beginning of the critical trial of Brazil is pending "notes" from ANVISA. What notes are they referring to?
As for what the notes are, also from the YMB:
Quote:
notes from the (meeting). not sure how it works there, but in the US, if you don't wait for the meeting notes or official letter, you can end up missing something - like a requested change to an ICF (informed consent form). if you get that, you have to either accept their changes, incorporate them, get the ICF approved internally and send back to the ethics committee for the approved stamp. if someone signs an ICF that doesn't have the approved stamp, you'll get dinged in an audit, have to confirm nothing was done that wasn't included in the ICF they signed, track the error for the ICF and possibly put a corrective action plan in place. it's easier to wait for the notes.
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