Financial Disclosures Flashcards
Financial disclosure in clinical trial under an IND is done on:
a) Form 1571
b) Form 1572
c) Form 3455
d) MedWatch 3500 A
c) Form 3455
With respect to financial disclosure by the principal investigator in a clinical trial the FDA requires:
a) Disclosure of any financial arrangement
b) Financial arrangements that could influence the outcome of the study
c) Financial arrangements that meet the threshold requirements set forth in Form 3455
d) All of the above
d) All of the above
a) Disclosure of any financial arrangement
b) Financial arrangements that could influence the outcome of the study
c) Financial arrangements that meet the threshold requirements set forth in Form 3455
FDA requires the disclosure by the principal investigator of financial payments of an amount greater than:
a) $5,000
b) $10,000
c) $25,000
d) $50,000
c) $25,000
FDA requires disclosure by the principal investigator of equity interest greater than:
a) $10,000
b) $25,000
c) $50,000
d) $75,000
c) $50,000
FDA requires disclosure by the principal investigator of proprietary interest which includes:
a) Patents
b) Copyright or trademark
c) Intellectual property
d) All of the above
d) All of the above
a) Patents
b) Copyright or trademark
c) Intellectual property
FDA requires reporting of any financial interest of the principal investigator in the sponsor:
a) Immediately before the trial begins
b) During the clinical trial
c) For a period of one year after study closure at the site.
d) All of the above
d) All of the above
a) Immediately before the trial begins
b) During the clinical trial
c) For a period of one year after study closure at the site.
The principal investigator in an IND study owns shares in a mutual fund that invests in the stock of the sponsor as one of its holdings. The investigator:
a) Must disclose this to the FDA on form 3455
b) Need not disclose this to the FDA on Form 3455
c) Must disclose this to the institutional conflict of interest
d) Must disclose this on the consent form
b) Need not disclose this to the FDA on Form 3455
The principal investigator’s wife owns equity interest greater than $50,000 directly in the sponsor’s stock.
The principal investigator:
a) Must disclose this to the FDA on form 3455
b) Need not disclose this to the FDA on Form 3455
c) Must disclose this to the institutional conflict of interest committee
d) Must disclose this on the consent form
a) Must disclose this to the FDA on form 3455
The principal investigator receives a cash payment for consultation from the sponsor in the amount of $10,000. This amount is:
a) Below the threshold amount for disclosure to the FDA
b) May have to be disclosed to the conflict of interest committee
c) May have to be disclosed to the IRB if required by the institutional guidelines
d) All of the above.
d) All of the above.
a) Below the threshold amount for disclosure to the FDA
b) May have to be disclosed to the conflict of interest committee
c) May have to be disclosed to the IRB if required by the institutional guidelines
The conflict of interest committee reviewing the disclosure of a PI on an FDA dinical trial in the amount of $10,000:
a) May require the PI to transfer consenting responsibilities to others on the research team
b) May require the Pl to transfer the principal investigator duties to the co-investigator who does not have a conflict of interest
c) May develop a customized conflict of interest management plan specific to this situation.
d) All of the above.
d) All of the above.
a) May require the PI to transfer consenting responsibilities to others on the research team
b) May require the Pl to transfer the principal investigator duties to the co-investigator who does not have a conflict of interest
c) May develop a customized conflict of interest management plan specific to this situation.
The threshold payment amounts to be disclosed to the institutional conflict of interest committees in most institutions:
a) Are the same as the FDA guidelines
b) Are greater than the FDA guidelines
c) Are less than the FDA guidelines
d) Are greater than the NIH guidelines
c) Are less than the FDA guidelines
