SOCRA Practice Test UPDATED ACTUAL Questions and CORRECT Answers
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Course
SOCRA
Institution
SOCRA
SOCRA Practice Test UPDATED ACTUAL
Questions and CORRECT Answers
Which of the following is a disclosure of financial interests form? - CORRECT
ANSWER- FDA Form 3455
Which of the following is a certification of financial interest form? - CORRECT
ANSWER- FDA Form 3454
If the investigator did...
SOCRA Practice Test UPDATED ACTUAL
Questions and CORRECT Answers
Which of the following is a disclosure of financial interests form? - CORRECT
ANSWER✔✔- FDA Form 3455
Which of the following is a certification of financial interest form? - CORRECT
ANSWER✔✔- FDA Form 3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the
following form: - CORRECT ANSWER✔✔- FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial -
CORRECT ANSWER✔✔- Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? - CORRECT
ANSWER✔✔- Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is - CORRECT
ANSWER✔✔- 3500
Medical device adverse events/problems are reported via a form: - CORRECT
ANSWER✔✔- 3500A
What is FDA form 1571? - CORRECT ANSWER✔✔- Cover-sheet for Investigational New
Drug Applications
21 CFR 312 deals with - CORRECT ANSWER✔✔- Investigational New Drug Application
Investigational new drug means - CORRECT ANSWER✔✔- 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 - CORRECT ANSWER✔✔- "Caution: New Drug—Limited by
Federal (or United States) law to investigational use."
Which of the following is not listed on FDA form 1571: - CORRECT ANSWER✔✔-
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... - CORRECT
ANSWER✔✔- Life threatening adverse drug experience
What are the three main basic ethical principles of the Belmont Report? - CORRECT
ANSWER✔✔- 1. Respect for Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? - CORRECT ANSWER✔✔- 1. Informed
Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What phrase of a drug trial usually includes hundreds to thousands of volunteers? -
CORRECT ANSWER✔✔- Phase 3: These studies gather more information about safety and
effectiveness, study different populations and different dosages, and uses the drug in
combination with other drugs.
What is a drug as defined by the FDA? - CORRECT ANSWER✔✔- A drug is an product
that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease;
and that is intended to affect the structure or any function of the body.
What is Phase 1 of a clinical trial? - CORRECT ANSWER✔✔- 20-80: Typical number of
healthy volunteers used in Phase 1: this phase emphasizes SAFETY.
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