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jlanteigne ☆ 2011-03-24 00:14 (5562 d 21:23 ago) Posting: # 6798 Views: 4,608 |
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Dear all, Here is my case: A sub-investigator (physician) perfoming subjects initial visit (screening), has been delegated by the Investigator to performed this trial related task and he also signed the signature log. Therefore, subjects screened by that sub-investigator were not dosed in the study. Should that sub-investigator be listed on the 1572 form of the study? Thanks Johanne |
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Ohlbe ★★★ France, 2011-03-24 01:20 (5562 d 20:17 ago) @ jlanteigne Posting: # 6799 Views: 3,970 |
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Dear Johanne, First of all the 1572 form is only needed if the study is run under an IND. This can be the case in a BA or in a bridge BE, but it is very unusual in a BE for generic drugs. Did you look at this Q&A ? Particularly points 31 and 7 ? Regards Ohlbe — Regards Ohlbe |
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jlanteigne ☆ 2011-03-24 16:34 (5562 d 05:03 ago) @ Ohlbe Posting: # 6807 Views: 3,949 |
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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 |
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Ohlbe ★★★ France, 2011-03-24 19:56 (5562 d 01:41 ago) @ jlanteigne Posting: # 6809 Views: 3,861 |
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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 — Regards Ohlbe |
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aracine ● 2011-03-25 21:04 (5561 d 00:33 ago) (edited on 2011-03-25 22:51) @ jlanteigne Posting: # 6814 Views: 3,780 |
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Hi Johanne ! According to FDA guideline on financial disclosure : "The sponsor, who is in contact with the investigator, is best placed to inquire as to the financial arrangements of investigators, and this obligation applies to any IND/IDE sponsor (e.g., commercial, government or CRO). The IND/IDE sponsor shall maintain complete and accurate records showing any financial interest as described in Section 54.4 (a) (3) (i-iv) in a sponsor of the covered study. The IND/IDE sponsor is responsible for ensuring that required financial information is collected and is made available to the applicant company, so that, the information can be included in the NDA/BLA/PMA submission. Annie Edit: guidance linked [Ohlbe] |
Ing. Helmut Schütz