SOCRA Practice Test Exam Question And
Answers 2024
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 And
Answers 2024
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
, SOCRA Practice Test Exam Question And
Answers 2024
What are the three main basic ethical principles of the
Belmont Report? - correct answers✅1. Respect for
Persons
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.
Answers 2024
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 And
Answers 2024
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
, SOCRA Practice Test Exam Question And
Answers 2024
What are the three main basic ethical principles of the
Belmont Report? - correct answers✅1. Respect for
Persons
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.
