Bioequivalence and Bioavailability Forum

Hello,

Here is another question related to the previous one.

As per FDA, CFR 312.53 c) (4): Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain the following:
(1) A signed investigator statement (Form FDA-1572)
(2) Curriculum vitae of the investigator
(3) Financial disclosure information.

I know that 1572 is required for IND only do financial disclosure also required for IND only?

Do you think that the sponsor should received financial disclosure of the investigator and all subinvestigators before they begin their participation in the trial or only at the time of the final report? If yes, Is it the sponsor responsibility to require those documents or to the investigator to provide them before the begining of the trial?


Thanks
Johanne