Which of the following is a disclosure of financial interests form? - ✔✔FDA Form 3455
Which of the following is a certification of financial interest form? - ✔✔FDA Form 3454
If the investigator did have financial arran
...
Which of the following is a disclosure of financial interests form? - ✔✔FDA Form 3455
Which of the following is a certification of financial interest form? - ✔✔FDA Form 3454
If the investigator did have financial arrangement with the sponsor, he/she would submit
the following form: - ✔✔FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial -
✔✔Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? - ✔✔Office of
Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is - ✔✔3500
Medical device adverse events/problems are reported via a form: - ✔✔3500A
What is FDA form 1571? - ✔✔Cover-sheet for Investigational New Drug Applications
21 CFR 312 deals with - ✔✔Investigational New Drug Application
Investigational new drug means - ✔✔A new drug or biological drug that is used in a
clinical investigation
The immediate package of an investigational new drug intended for human use shall
bear a label with the statement - ✔✔"Caution: New Drug—Limited by Federal (or United
States) law to investigational use."
Which of the following is not listed on FDA form 1571: - ✔✔Approved informed consent
document
"Any adverse drug experience that places the patient or subject, in the view of the
investigator, at immediate risk of death from the reaction as it occurred" Is... - ✔✔Life
threatening adverse drug experience
What are the three main basic ethical principles of the Belmont Report? - ✔✔1. Respect
for Persons
2. Beneficence
3. Justice
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