SOCRA Practice Test 2024 Q&A
Which of the following is a disclosure of financial interests form? - ANS FDA Form
3455
Which of the following is a certification of financial interest form? - ANS FDA Form
3454
If the investigator did have financial arrangement with the sponsor, he/she would
submit the following form: - ANS FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial -
ANS Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? - ANS
Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is - ANS 3500
Medical device adverse events/problems are reported via a form: - ANS 3500A
What is FDA form 1571? - ANS Cover-sheet for Investigational New Drug
Applications
21 CFR 312 deals with - ANS Investigational New Drug Application
Investigational new drug means - ANS 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 - ANS "Caution: New Drug—Limited by Federal (or
United States) law to investigational use."
Which of the following is not listed on FDA form 1571: - ANS 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... - ANS
Life threatening adverse drug experience
What are the three main basic ethical principles of the Belmont Report? - ANS 1.
Respect for Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? - ANS 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? -
ANS 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? - ANS 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? - ANS 20-80: Typical number of healthy
volunteers used in Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a clinical trial? - ANS 100s: Typical number of patients used in
Phase 2; this phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? - ANS 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? - ANS 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 - ANS Protection of Human Subjects
Subpart D of 21 CFR 50 lists the - ANS 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 - ANS a. true X (21 CFR 56.110 Subpart D)
b. false
A Phase ___ protocol is more flexible and less detailed than the others. - ANS
Phase 1
A source document is any document found that is associated with a clinical trial. -
ANS a. true
b. false X (A source document is any document where the date are FIRST recorded)
A sponsor will not ship a study drug until they have received all of the following
documents: - ANS - IRB approved protocol, IRB approved informed consent form,
IRB approval letter, IRB approved recruitment materials
- Signed and completed 1572, CV's and financial disclosures from everyone listed on
1572
- Current lab certifications and normal ranges
Which of the following is a disclosure of financial interests form? - ANS FDA Form
3455
Which of the following is a certification of financial interest form? - ANS FDA Form
3454
If the investigator did have financial arrangement with the sponsor, he/she would
submit the following form: - ANS FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial -
ANS Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? - ANS
Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is - ANS 3500
Medical device adverse events/problems are reported via a form: - ANS 3500A
What is FDA form 1571? - ANS Cover-sheet for Investigational New Drug
Applications
21 CFR 312 deals with - ANS Investigational New Drug Application
Investigational new drug means - ANS 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 - ANS "Caution: New Drug—Limited by Federal (or
United States) law to investigational use."
Which of the following is not listed on FDA form 1571: - ANS 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... - ANS
Life threatening adverse drug experience
What are the three main basic ethical principles of the Belmont Report? - ANS 1.
Respect for Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? - ANS 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? -
ANS 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? - ANS 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? - ANS 20-80: Typical number of healthy
volunteers used in Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a clinical trial? - ANS 100s: Typical number of patients used in
Phase 2; this phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? - ANS 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? - ANS 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 - ANS Protection of Human Subjects
Subpart D of 21 CFR 50 lists the - ANS 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 - ANS a. true X (21 CFR 56.110 Subpart D)
b. false
A Phase ___ protocol is more flexible and less detailed than the others. - ANS
Phase 1
A source document is any document found that is associated with a clinical trial. -
ANS a. true
b. false X (A source document is any document where the date are FIRST recorded)
A sponsor will not ship a study drug until they have received all of the following
documents: - ANS - IRB approved protocol, IRB approved informed consent form,
IRB approval letter, IRB approved recruitment materials
- Signed and completed 1572, CV's and financial disclosures from everyone listed on
1572
- Current lab certifications and normal ranges
