SOCRA COMPREHENSIVE QUESTIONS
WITH VERIFIED SOLUTIONS AND
PRACTICE NOTES
●● Which of the following is a certification of financial interest form?
Answer: FDA Form 3454
●● If the investigator did have financial arrangement with the sponsor,
he/she would submit the following form:
Answer: FDA Form 3455
●● This form is submitted by sponsor to the FDA prior to the beginning
of the drug trial
Answer: Investigational New Drug Application (1571)
●● In the top right corner, form have OMB number. What does it stand
for?
Answer: Office of Management and Budget
●● The form, which is submitted to the FDA to report an Adverse Event
is
Answer: 3500
,●● Medical device adverse events/problems are reported via a form:
Answer: 3500A
●● What is FDA form 1571?
Answer: Cover-sheet for Investigational New Drug Applications
●● 21 CFR 312 deals with
Answer: Investigational New Drug Application
●● Investigational new drug means
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
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:
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...
Answer: Life threatening adverse drug experience
●● What are the three main basic ethical principles of the Belmont
Report?
Answer: 1. Respect for Persons
2. Beneficence
3. Justice
●● What are the applications for the Belmont Report?
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?
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?
WITH VERIFIED SOLUTIONS AND
PRACTICE NOTES
●● Which of the following is a certification of financial interest form?
Answer: FDA Form 3454
●● If the investigator did have financial arrangement with the sponsor,
he/she would submit the following form:
Answer: FDA Form 3455
●● This form is submitted by sponsor to the FDA prior to the beginning
of the drug trial
Answer: Investigational New Drug Application (1571)
●● In the top right corner, form have OMB number. What does it stand
for?
Answer: Office of Management and Budget
●● The form, which is submitted to the FDA to report an Adverse Event
is
Answer: 3500
,●● Medical device adverse events/problems are reported via a form:
Answer: 3500A
●● What is FDA form 1571?
Answer: Cover-sheet for Investigational New Drug Applications
●● 21 CFR 312 deals with
Answer: Investigational New Drug Application
●● Investigational new drug means
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
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:
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...
Answer: Life threatening adverse drug experience
●● What are the three main basic ethical principles of the Belmont
Report?
Answer: 1. Respect for Persons
2. Beneficence
3. Justice
●● What are the applications for the Belmont Report?
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?
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?
