SOCRA Practice Test Latest Updated Graded A+
/. Which of the following is a disclosure of financial interests form? - Answer-✅FDA
Form 3455
/.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? - 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? - Answer-✅20-80: Typical number of healthy
volunteers used in Phase 1: this phase emphasizes SAFETY.
/.What is Phase 2 of a clinical trial? - Answer-✅100s: Typical number of patients used
in Phase 2; this phase emphasizes EFFECTIVENESS
/.What is Phase 3 of a clinical trial? - 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? - 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 - Answer-✅Protection of Human Subjects
/.Subpart D of 21 CFR 50 lists the - 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 -
Answer-✅a. true X (21 CFR 56.110 Subpart D)
b. false
/. Which of the following is a disclosure of financial interests form? - Answer-✅FDA
Form 3455
/.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? - 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? - Answer-✅20-80: Typical number of healthy
volunteers used in Phase 1: this phase emphasizes SAFETY.
/.What is Phase 2 of a clinical trial? - Answer-✅100s: Typical number of patients used
in Phase 2; this phase emphasizes EFFECTIVENESS
/.What is Phase 3 of a clinical trial? - 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? - 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 - Answer-✅Protection of Human Subjects
/.Subpart D of 21 CFR 50 lists the - 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 -
Answer-✅a. true X (21 CFR 56.110 Subpart D)
b. false
