SOCRA PRACTICE TEST 2025 WITH
WELL DETAILED SOLUTIONS ALREADY
GRADED A+
Which of the following is a disclosure of financial interests form? CORRECT ANSWERFDA Form 3455
Which of the following is a certification of financial interest form? CORRECT ANSWERFDA Form 3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the following
form: CORRECT ANSWERFDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial CORRECT
ANSWERInvestigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? CORRECT ANSWEROffice of
Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is CORRECT ANSWER3500
Medical device adverse events/problems are reported via a form: CORRECT ANSWER3500A
What is FDA form 1571? CORRECT ANSWERCover-sheet for Investigational New Drug Applications
21 CFR 312 deals with CORRECT ANSWERInvestigational New Drug Application
,Investigational new drug means CORRECT ANSWERA 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 ANSWERApproved 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 ANSWERLife threatening adverse
drug experience
What are the three main basic ethical principles of the Belmont Report? CORRECT ANSWER1. Respect
for Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? CORRECT ANSWER1. 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
ANSWERPhase 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 ANSWERA 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 ANSWER20-80: Typical number of healthy volunteers used in
Phase 1: this phase emphasizes SAFETY.
,What is Phase 2 of a clinical trial? CORRECT ANSWER100s: Typical number of patients used in Phase 2;
this phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? CORRECT ANSWER1000'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 ANSWERPost 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 ANSWERProtection of Human Subjects
Subpart D of 21 CFR 50 lists the CORRECT ANSWERAdditional 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 ANSWERa. true X (21 CFR
56.110 Subpart D)
b. false
A Phase ___ protocol is more flexible and less detailed than the others. CORRECT ANSWERPhase 1
A source document is any document found that is associated with a clinical trial. CORRECT ANSWERa.
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: CORRECT
ANSWER- 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
Certification of absence of financial interest would also be known as: CORRECT ANSWERForm 3454
What is the minimum number of IRB members? CORRECT ANSWER5
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new
dosage would be? CORRECT ANSWER77
The responsibility for ensuring that the investigator understands a clinical trial lies with CORRECT
ANSWERthe sponsor
Significant risk device is defined as an investigational device that is: CORRECT ANSWERa. Intended as an
implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a
potential risk to the health, safety, or welfare of a subject.
c. for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise
preventing impairment of human health and presents a potential for serious risk to the health, safety, or
welfare of a subject.
Answer: All the above
A purpose of monitoring clinical trials is to verify that: CORRECT ANSWERThe rights, safety and well-
being of human subjects are protected.
A sponsor may transfer responsibility for any of all of the obligations to a CORRECT ANSWERContract
Research Organization (CRO)
A contract research organization shall be responsible for : CORRECT ANSWER- Control of the Drug
- Selecting Investigators
- Obtaining information from the investigators
WELL DETAILED SOLUTIONS ALREADY
GRADED A+
Which of the following is a disclosure of financial interests form? CORRECT ANSWERFDA Form 3455
Which of the following is a certification of financial interest form? CORRECT ANSWERFDA Form 3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the following
form: CORRECT ANSWERFDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial CORRECT
ANSWERInvestigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? CORRECT ANSWEROffice of
Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is CORRECT ANSWER3500
Medical device adverse events/problems are reported via a form: CORRECT ANSWER3500A
What is FDA form 1571? CORRECT ANSWERCover-sheet for Investigational New Drug Applications
21 CFR 312 deals with CORRECT ANSWERInvestigational New Drug Application
,Investigational new drug means CORRECT ANSWERA 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 ANSWERApproved 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 ANSWERLife threatening adverse
drug experience
What are the three main basic ethical principles of the Belmont Report? CORRECT ANSWER1. Respect
for Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? CORRECT ANSWER1. 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
ANSWERPhase 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 ANSWERA 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 ANSWER20-80: Typical number of healthy volunteers used in
Phase 1: this phase emphasizes SAFETY.
,What is Phase 2 of a clinical trial? CORRECT ANSWER100s: Typical number of patients used in Phase 2;
this phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? CORRECT ANSWER1000'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 ANSWERPost 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 ANSWERProtection of Human Subjects
Subpart D of 21 CFR 50 lists the CORRECT ANSWERAdditional 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 ANSWERa. true X (21 CFR
56.110 Subpart D)
b. false
A Phase ___ protocol is more flexible and less detailed than the others. CORRECT ANSWERPhase 1
A source document is any document found that is associated with a clinical trial. CORRECT ANSWERa.
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: CORRECT
ANSWER- 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
Certification of absence of financial interest would also be known as: CORRECT ANSWERForm 3454
What is the minimum number of IRB members? CORRECT ANSWER5
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new
dosage would be? CORRECT ANSWER77
The responsibility for ensuring that the investigator understands a clinical trial lies with CORRECT
ANSWERthe sponsor
Significant risk device is defined as an investigational device that is: CORRECT ANSWERa. Intended as an
implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a
potential risk to the health, safety, or welfare of a subject.
c. for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise
preventing impairment of human health and presents a potential for serious risk to the health, safety, or
welfare of a subject.
Answer: All the above
A purpose of monitoring clinical trials is to verify that: CORRECT ANSWERThe rights, safety and well-
being of human subjects are protected.
A sponsor may transfer responsibility for any of all of the obligations to a CORRECT ANSWERContract
Research Organization (CRO)
A contract research organization shall be responsible for : CORRECT ANSWER- Control of the Drug
- Selecting Investigators
- Obtaining information from the investigators
