SOCRA Practice Test QUESTIONS
AND ANSWERS GRADED A
Which of the following is a disclosure of financial interests form? Correct Answer: FDA Form
3455
Which of the following is a certification of financial interest form? Correct Answer: FDA Form
3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the
following form: Correct Answer: FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Correct
Answer: Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? Correct Answer: Office
of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is Correct Answer: 3500
Medical device adverse events/problems are reported via a form: Correct Answer: 3500A
What is FDA form 1571? Correct Answer: Cover-sheet for Investigational New Drug
Applications
21 CFR 312 deals with Correct Answer: Investigational New Drug Application
Investigational new drug means Correct 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 Correct 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: Correct 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... Correct Answer: Life threatening
adverse drug experience
What are the three main basic ethical principles of the Belmont Report? Correct Answer: 1.
Respect for Persons
2. Beneficence
, 3. Justice
What are the applications for the Belmont Report? Correct 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? 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.
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.
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.
What is Phase 2 of a clinical trial? Correct Answer: 100s: Typical number of patients used in
Phase 2; this phase emphasizes EFFECTIVENESS
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.
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.
The main concept of 21 CFR 50 is Correct Answer: Protection of Human Subjects
Subpart D of 21 CFR 50 lists the Correct Answer: Additional Safeguards for children in Clinical
Investigations
The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review
procedure when necessary to protect the rights or welfare of subject Correct Answer: a. true X
(21 CFR 56.110 Subpart D)
b. false
A Phase ___ protocol is more flexible and less detailed than the others. Correct Answer: Phase 1
A source document is any document found that is associated with a clinical trial. Correct
Answer: a. true
b. false X (A source document is any document where the date are FIRST recorded)
AND ANSWERS GRADED A
Which of the following is a disclosure of financial interests form? Correct Answer: FDA Form
3455
Which of the following is a certification of financial interest form? Correct Answer: FDA Form
3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the
following form: Correct Answer: FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Correct
Answer: Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? Correct Answer: Office
of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is Correct Answer: 3500
Medical device adverse events/problems are reported via a form: Correct Answer: 3500A
What is FDA form 1571? Correct Answer: Cover-sheet for Investigational New Drug
Applications
21 CFR 312 deals with Correct Answer: Investigational New Drug Application
Investigational new drug means Correct 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 Correct 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: Correct 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... Correct Answer: Life threatening
adverse drug experience
What are the three main basic ethical principles of the Belmont Report? Correct Answer: 1.
Respect for Persons
2. Beneficence
, 3. Justice
What are the applications for the Belmont Report? Correct 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? 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.
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.
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.
What is Phase 2 of a clinical trial? Correct Answer: 100s: Typical number of patients used in
Phase 2; this phase emphasizes EFFECTIVENESS
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.
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.
The main concept of 21 CFR 50 is Correct Answer: Protection of Human Subjects
Subpart D of 21 CFR 50 lists the Correct Answer: Additional Safeguards for children in Clinical
Investigations
The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review
procedure when necessary to protect the rights or welfare of subject Correct Answer: a. true X
(21 CFR 56.110 Subpart D)
b. false
A Phase ___ protocol is more flexible and less detailed than the others. Correct Answer: Phase 1
A source document is any document found that is associated with a clinical trial. Correct
Answer: a. true
b. false X (A source document is any document where the date are FIRST recorded)
