9/15/25, 6:03 AM SOCRA Practice Test EXAM Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 EXAM Flashcards | Quizlet
SOCRA Practice Test EXAM Questions & Answers
| Latest Already Graded A+ UPDATE 2025|2026
EXAM
Save
Terms in this set (107)
Which of the following is a FDA Form 3455
disclosure of financial
interests form?
Which of the following is a FDA Form 3454
certification of financial
interest form?
If the investigator did have FDA Form 3455
financial arrangement with
the sponsor, he/she would
submit the following form:
This form is submitted by Investigational New Drug Application (1571)
sponsor to the FDA prior
to the beginning of the
drug trial
In the top right corner, Office of Management and Budget
form have OMB number.
What does it stand for?
The form, which is 3500
submitted to the FDA to
report an Adverse Event is
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,9/15/25, 6:03 AM SOCRA Practice Test EXAM Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 EXAM Flashcards | Quizlet
Medical device adverse 3500A
events/problems are
reported via a form:
Cover-sheet for Investigational New Drug
What is FDA form 1571?
Applications
21 CFR 312 deals with Investigational New Drug Application
Investigational new drug A new drug or biological drug that is used in a clinical
means investigation
The immediate package of "Caution: New Drug—Limited by Federal (or United
an investigational new States) law to investigational use."
drug intended for human
use shall bear a label with
the statement
Which of the following is Approved informed consent document
not listed on FDA form
1571:
"Any adverse drug Life threatening adverse drug experience
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...
What are the three main 1. Respect for Persons
basic ethical principles of 2. Beneficence
the Belmont Report? 3. Justice
1. Informed Consent
What are the applications
2. Assessment of Risk and Benefits
for the Belmont Report?
3. Selection of Subjects
What phrase of a drug trial Phase 3: These studies gather more information about
usually includes hundreds safety and effectiveness, study different populations
to thousands of and different dosages, and uses the drug in
volunteers? combination with other drugs.
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, 9/15/25, 6:03 AM SOCRA Practice Test EXAM Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 EXAM Flashcards | Quizlet
A drug is an product that is intended for use in the
What is a drug as defined diagnosis, cure mitigation, treatment, or prevention of
by the FDA? disease; and that is intended to affect the structure or
any function of the body.
What is Phase 1 of a 20-80: Typical number of healthy volunteers used in
clinical trial? Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a 100s: Typical number of patients used in Phase 2; this
clinical trial? phase emphasizes EFFECTIVENESS
1000's :Typical number of patients used in Phase. 3.
These studies gather more information about safety
What is Phase 3 of a
and effectiveness, study different populations and
clinical trial?
different dosages, and uses the drug in combination
with other drugs.
Post Marketing: Because it's not possible to predict all
of a drug's effects during clinical trials, monitoring
What is Phase 4 of a safety issues after drugs get on the market is critical.
clinical trial? The role of FDA's post-marketing safety system is to
detect serious unexpected adverse events and take
definitive action when needed.
The main concept of 21 Protection of Human Subjects
CFR 50 is
Subpart D of 21 CFR 50 Additional Safeguards for children in Clinical
lists the Investigations
The FDA may restrict, a. true X (21 CFR 56.110 Subpart D)
suspend, or terminate an b. false
institution's or IRB's use of
the expedited review
procedure when
necessary to protect the
rights or welfare of
subject
https://quizlet.com/1076462071/socra-practice-test-exam-questions-answers-latest-already-graded-a-update-20252026-exam-flash-cards/?new 3/17
SOCRA Practice Test EXAM Questions & Answers
| Latest Already Graded A+ UPDATE 2025|2026
EXAM
Save
Terms in this set (107)
Which of the following is a FDA Form 3455
disclosure of financial
interests form?
Which of the following is a FDA Form 3454
certification of financial
interest form?
If the investigator did have FDA Form 3455
financial arrangement with
the sponsor, he/she would
submit the following form:
This form is submitted by Investigational New Drug Application (1571)
sponsor to the FDA prior
to the beginning of the
drug trial
In the top right corner, Office of Management and Budget
form have OMB number.
What does it stand for?
The form, which is 3500
submitted to the FDA to
report an Adverse Event is
https://quizlet.com/1076462071/socra-practice-test-exam-questions-answers-latest-already-graded-a-update-20252026-exam-flash-cards/?new 1/17
,9/15/25, 6:03 AM SOCRA Practice Test EXAM Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 EXAM Flashcards | Quizlet
Medical device adverse 3500A
events/problems are
reported via a form:
Cover-sheet for Investigational New Drug
What is FDA form 1571?
Applications
21 CFR 312 deals with Investigational New Drug Application
Investigational new drug A new drug or biological drug that is used in a clinical
means investigation
The immediate package of "Caution: New Drug—Limited by Federal (or United
an investigational new States) law to investigational use."
drug intended for human
use shall bear a label with
the statement
Which of the following is Approved informed consent document
not listed on FDA form
1571:
"Any adverse drug Life threatening adverse drug experience
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...
What are the three main 1. Respect for Persons
basic ethical principles of 2. Beneficence
the Belmont Report? 3. Justice
1. Informed Consent
What are the applications
2. Assessment of Risk and Benefits
for the Belmont Report?
3. Selection of Subjects
What phrase of a drug trial Phase 3: These studies gather more information about
usually includes hundreds safety and effectiveness, study different populations
to thousands of and different dosages, and uses the drug in
volunteers? combination with other drugs.
https://quizlet.com/1076462071/socra-practice-test-exam-questions-answers-latest-already-graded-a-update-20252026-exam-flash-cards/?new 2/17
, 9/15/25, 6:03 AM SOCRA Practice Test EXAM Questions & Answers | Latest Already Graded A+ UPDATE 2025|2026 EXAM Flashcards | Quizlet
A drug is an product that is intended for use in the
What is a drug as defined diagnosis, cure mitigation, treatment, or prevention of
by the FDA? disease; and that is intended to affect the structure or
any function of the body.
What is Phase 1 of a 20-80: Typical number of healthy volunteers used in
clinical trial? Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a 100s: Typical number of patients used in Phase 2; this
clinical trial? phase emphasizes EFFECTIVENESS
1000's :Typical number of patients used in Phase. 3.
These studies gather more information about safety
What is Phase 3 of a
and effectiveness, study different populations and
clinical trial?
different dosages, and uses the drug in combination
with other drugs.
Post Marketing: Because it's not possible to predict all
of a drug's effects during clinical trials, monitoring
What is Phase 4 of a safety issues after drugs get on the market is critical.
clinical trial? The role of FDA's post-marketing safety system is to
detect serious unexpected adverse events and take
definitive action when needed.
The main concept of 21 Protection of Human Subjects
CFR 50 is
Subpart D of 21 CFR 50 Additional Safeguards for children in Clinical
lists the Investigations
The FDA may restrict, a. true X (21 CFR 56.110 Subpart D)
suspend, or terminate an b. false
institution's or IRB's use of
the expedited review
procedure when
necessary to protect the
rights or welfare of
subject
https://quizlet.com/1076462071/socra-practice-test-exam-questions-answers-latest-already-graded-a-update-20252026-exam-flash-cards/?new 3/17
