Bioequivalence and Bioavailability Forum • Sub-investigators on 1572 form and financial discosure

Sub-investigators on 1572 form and financial discosure [Regulatives / Guidelines]

posted by aracine – 2011-03-25 21:04 (5556 d 00:27 ago) – Posting: # 6814
Views: 3,768
(edited on 2011-03-25 22:51)

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]

Complete thread:

Sub-investigators on 1572 form jlanteigne 2011-03-23 23:14 [Regulatives / Guidelines]
- 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 discosure Ohlbe 2011-03-24 18:56
    - Sub-investigators on 1572 form and financial discosurearacine 2011-03-25 20:04