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RegisterSub-investigators on 1572 form and financial discosure [Regulatives / Guidelines]
Dear Johanne,
Have a look at 21CFR54.
According to §54.3, the requirement for financial disclosure applies to trials submitted in marketing applications. §54.2(e) gives details on the type of studies covered. None makes reference to IND so I would understand the requirement applies independently from the IND status of the studies.
I only had a quick look at Part 54 but a more detailed reading may help answer your other questions. There may also be a guidance document on the FDA web site; sorry I'm a bit short in time right now to search for it.
Regards
Ohlbe
Have a look at 21CFR54.
According to §54.3, the requirement for financial disclosure applies to trials submitted in marketing applications. §54.2(e) gives details on the type of studies covered. None makes reference to IND so I would understand the requirement applies independently from the IND status of the studies.
I only had a quick look at Part 54 but a more detailed reading may help answer your other questions. There may also be a guidance document on the FDA web site; sorry I'm a bit short in time right now to search for it.
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Sub-investigators on 1572 form jlanteigne 2011-03-23 23:14 [Regulatives / Guidelines]
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- Sub-investigators on 1572 form Ohlbe 2011-03-24 00:20
- Sub-investigators on 1572 form and financial discosure jlanteigne 2011-03-24 15:34
- Sub-investigators on 1572 form and financial discosureOhlbe 2011-03-24 18:56
- Sub-investigators on 1572 form and financial discosure aracine 2011-03-25 20:04
- Sub-investigators on 1572 form and financial discosure jlanteigne 2011-03-24 15:34
- Sub-investigators on 1572 form Ohlbe 2011-03-24 00:20
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