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PRACTICE QUESTIONS FOR SOCRA 2025|
BRAND NEW ACTUAL EXAM WITH 100%
VERIFIED QUESTIONS AND CORRECT
SOLUTIONS| GUARANTEED VALUE PACK| ACE
YOUR GRADES.
1. Which of the following is not listed on FDA form 1571: - correct
answer - a. name, address, phone number of the sponsor
b. a commitment not to start the clinical investifation until the
InD is in effect
c. identification of the phase of the trail
d. approved informed consent document
2. "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 - a.
serious adverse drug experience
b. life threatening adverse drug experience
c. none of the above
3. What are the three main basic ethical principles of the Belmont
Report? - correct answer - 1. Respect for Persons
2. Beneficence
3. Justice
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4. What are the applications for the Belmont Report? - correct
answer - 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
5. 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.
6. 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.
7. 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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8. What is Phase 2 of a clinical trial? - correct answer - 100s:
Typical number of patients used in Phase 2; this phase
emphasizes EFFECTIVENESS
9. What is Phase 3 of a clinical trial? - correct answer - 1000's
:Typical number of patients used in 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.
10. What is Phase 4 of a clinical trial? - correct answer - Post
Marketing: Because it's not possible to predict all of a drug's
effects during clinical trials, monitoring safety issues after drugs
get on the market is critical. The role of FDA's post-marketing
safety system is to detect serious unexpected adverse events
and take definitive action when needed.
11. This form is submitted by sponsor to the FDA prior to the
beginning of the drug trial - correct answer - Investigational
New Drug Application
12. In the top right corner, form have OMB number. What does it
stand for? - correct answer -
PRACTICE QUESTIONS FOR SOCRA 2025|
BRAND NEW ACTUAL EXAM WITH 100%
VERIFIED QUESTIONS AND CORRECT
SOLUTIONS| GUARANTEED VALUE PACK| ACE
YOUR GRADES.
1. Which of the following is not listed on FDA form 1571: - correct
answer - a. name, address, phone number of the sponsor
b. a commitment not to start the clinical investifation until the
InD is in effect
c. identification of the phase of the trail
d. approved informed consent document
2. "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 - a.
serious adverse drug experience
b. life threatening adverse drug experience
c. none of the above
3. What are the three main basic ethical principles of the Belmont
Report? - correct answer - 1. Respect for Persons
2. Beneficence
3. Justice
, Page | 2
4. What are the applications for the Belmont Report? - correct
answer - 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
5. 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.
6. 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.
7. 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.
, Page | 3
8. What is Phase 2 of a clinical trial? - correct answer - 100s:
Typical number of patients used in Phase 2; this phase
emphasizes EFFECTIVENESS
9. What is Phase 3 of a clinical trial? - correct answer - 1000's
:Typical number of patients used in 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.
10. What is Phase 4 of a clinical trial? - correct answer - Post
Marketing: Because it's not possible to predict all of a drug's
effects during clinical trials, monitoring safety issues after drugs
get on the market is critical. The role of FDA's post-marketing
safety system is to detect serious unexpected adverse events
and take definitive action when needed.
11. This form is submitted by sponsor to the FDA prior to the
beginning of the drug trial - correct answer - Investigational
New Drug Application
12. In the top right corner, form have OMB number. What does it
stand for? - correct answer -
