Practice Questions for SOCRA exam VERIFIED

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Practice Questions for SOCRA exam VERIFIED

Question 1: Which of the following is a disclosure of financial

interests form?

CORRECT ANSWER : FDA Form 3455

Question 2: Which of the following is a certification of financial

interest form?

CORRECT ANSWER : FDA Form 3454

Question 3: If the investigator did have financial arrangement

with the sponsor, he/she would submit the following form:

CORRECT ANSWER : FDA Form 3455

Question 4: This form is submitted by sponsor to the FDA prior

to the beginning of the drug trial

CORRECT ANSWER : Investigational New Drug Application

(1571)

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Question 5: In the top right corner, form have OMB number.

What does it stand for?

CORRECT ANSWER : Office of Management and Budget

Question 6: The form, which is submitted to the FDA to report

an Adverse Event is

CORRECT ANSWER: 3500

Question 7: Medical device adverse events/problems are

reported via a form:

CORRECT ANSWER : 3500A

Question 8: What is FDA form 1571?

CORRECT ANSWER : Cover-sheet for Investigational New

Drug Applications

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Question 9: 21 CFR 312 deals with

CORRECT ANSWER : Investigational New Drug Application

Question 10: Investigational new drug means

CORRECT ANSWER : A new drug or biological drug that is

used in a clinical investigation

Question 11: The immediate package of an investigational new

drug intended for human use shall bear a label with the statement

CORRECT ANSWER : "Caution: New Drug—Limited by Federal (or United States) law to investigational use."

Question 12: Which of the following is not listed on FDA form

1571:

CORRECT ANSWER : Approved informed consent document

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Question 13: "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...

CORRECT ANSWER : Life threatening adverse drug

experience

Question 14: What are the three main basic ethical principles of

the Belmont Report?

CORRECT ANSWER : 1. Respect for Persons 2. Beneficence 3.

Justice

Question 15: What are the applications for the Belmont Report?

CORRECT ANSWER : 1. Informed Consent 2. Assessment of

Risk and Benefits 3. Selection of Subjects

Question 16: What phrase of a drug trial usually includes

hundreds to thousands of volunteers?