SOCRA Practice Test Exam Question
& Answers ( Latest update)
Which of the following is a disclosure of financial interests form? -
CORRECT ANSWERS ✔✔FDA Form 3455
Which of the following is a certification of financial interest form? -
CORRECT ANSWERS ✔✔FDA Form 3454
If the investigator did have financial arrangement with the sponsor,
he/she would submit the following form: - CORRECT ANSWERS
✔✔FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of
the drug trial - CORRECT ANSWERS ✔✔Investigational New Drug
Application (1571)
In the top right corner, form have OMB number. What does it stand
for? - CORRECT ANSWERS ✔✔Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is -
CORRECT ANSWERS ✔✔3500
Medical device adverse events/problems are reported via a form: -
CORRECT ANSWERS ✔✔3500A
,SOCRA Practice Test Exam Question
& Answers ( Latest update)
What is FDA form 1571? - CORRECT ANSWERS ✔✔Cover-sheet for
Investigational New Drug Applications
21 CFR 312 deals with - CORRECT ANSWERS ✔✔Investigational
New Drug Application
Investigational new drug means - CORRECT ANSWERS ✔✔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 ANSWERS
✔✔"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
ANSWERS ✔✔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 ANSWERS ✔✔Life threatening
adverse drug experience
What are the three main basic ethical principles of the Belmont Report?
- CORRECT ANSWERS ✔✔1. Respect for Persons
, SOCRA Practice Test Exam Question
& Answers ( Latest update)
2. Beneficence
3. Justice
What are the applications for the Belmont Report? - CORRECT
ANSWERS ✔✔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 ANSWERS ✔✔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 ANSWERS ✔✔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 ANSWERS ✔✔20-80:
Typical number of healthy volunteers used in Phase 1: this phase
emphasizes SAFETY.
& Answers ( Latest update)
Which of the following is a disclosure of financial interests form? -
CORRECT ANSWERS ✔✔FDA Form 3455
Which of the following is a certification of financial interest form? -
CORRECT ANSWERS ✔✔FDA Form 3454
If the investigator did have financial arrangement with the sponsor,
he/she would submit the following form: - CORRECT ANSWERS
✔✔FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of
the drug trial - CORRECT ANSWERS ✔✔Investigational New Drug
Application (1571)
In the top right corner, form have OMB number. What does it stand
for? - CORRECT ANSWERS ✔✔Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is -
CORRECT ANSWERS ✔✔3500
Medical device adverse events/problems are reported via a form: -
CORRECT ANSWERS ✔✔3500A
,SOCRA Practice Test Exam Question
& Answers ( Latest update)
What is FDA form 1571? - CORRECT ANSWERS ✔✔Cover-sheet for
Investigational New Drug Applications
21 CFR 312 deals with - CORRECT ANSWERS ✔✔Investigational
New Drug Application
Investigational new drug means - CORRECT ANSWERS ✔✔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 ANSWERS
✔✔"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
ANSWERS ✔✔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 ANSWERS ✔✔Life threatening
adverse drug experience
What are the three main basic ethical principles of the Belmont Report?
- CORRECT ANSWERS ✔✔1. Respect for Persons
, SOCRA Practice Test Exam Question
& Answers ( Latest update)
2. Beneficence
3. Justice
What are the applications for the Belmont Report? - CORRECT
ANSWERS ✔✔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 ANSWERS ✔✔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 ANSWERS ✔✔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 ANSWERS ✔✔20-80:
Typical number of healthy volunteers used in Phase 1: this phase
emphasizes SAFETY.
