ACRP CP EXAM 2024 | ACCURATE 2 CURRENTLY TESTING
EXAMS WITH A STUDY GUIDE AND KNOWLEDGE CHECK
FLASHCARDS WITH SUMMARIZED INSTRUCTOR NOTES
AT THE END FOR A GUARANTED PASS
Who is ultimately responsible for Source Data Verification (SDV)?
A. The coordinator
b. The subject
c. The monitor
d. The investigator
C
Every research study involving human subjects must be registered in a publicly accessible
database
before recruitment of the first subject.
A. True b. False
A
The Declaration of Helsinki was developed by:
a. The Nuremberg tribunal
b. The World Medical Association
c. The government of Finland
d. The American Medical Association
B
This phase determines therapeutic benefit and is usually done in a larger, specific population.
A. Phase 1
b. Phase 2
c. Phase 3
d. Phase 4
C
This phase begins after drug approval and explores therapeutic use:
a. Phase 1
b. Phase 2
c. Phase 3
d. Phase 4
D
This is the most typical study. Investigates human pharmacology. It is the initial administration
or an
investigational new drug into humans. It is most commonly done in healthy subjects.
,A. Phase 1
b. Phase 2
c. Phase 3
d. Phase 4
A
Providing a unified standard for Europe US, and Japan to facilitate the acceptance of clinical
trials is
the...
A. Mission statement of the ICH
b. Mission statement of the Declaration
of Helsinki
c. Mission statement of the GCP Guidelines
d. Mission statement of Canada Health
A
An investigator can be defined as... (Select all that apply)
a. A person responsible for the conduct of the clinical trial with the sponsor
b. A person responsible for writing the trial protocol
c. The responsible leader of the clinical research team at the site and may be called the
principal investigator
d. A person responsible for the conduct of the clinical trial at that site
C, d
A sub-investigator can be defined as...
A. The clinical research coordinator (CRC) or clinical trial nurse
b. Any individual member of the clinical trial team designated and supervised by the investigator
at a trial site to perform critical trial-related procedures and/or to make important trial-related
decisions
c. Any individual member of the clinical trial team supervised by the investigator at a trial site to
perform trial-related procedures
d. Any individual member of the clinical trial team that performs trial related duties
B
A sponsor can be defined as...
A. An individual who both initiates and conducts, alone or with others, a clinical trial
b. An individual who participates in a clinical trial
c. An individual or juridical or other body authorized under applicable law to consent to the
subject's participation in the clinical trial
d. An individual, company, institution, or organization which takes responsibility for the
initiation,
management, and/or financing a clinical trial
,D
What is the purpose of ICH-GCP?
A. To standardize the design, conduct, recording, and reporting of clinical trials
b. To instruct clinicians as to how to conduct preclinical toxicology tests
c. To ensure that subjects are treated with the best available therapy
d. To increase the number of abbreviations used in clinical practice
A
What is the purpose of the IRB/IEC?
A. To help ensure that trials are
conducted according to the protocol
b. To monitor clinical trials
c. To design trial protocols
d. To protect subject safety
D
According to ICH, the abbreviation 'LAR' stands for 'Legally authorized Representative'.
A. True b. False
B
What is the minimum number of members on an IRB/IEC?
A. 3
b. 5
c. 7
d. 8
B
Who is responsible for providing the trial protocol?
A. The sponsor
b. The investigator
c. The IRB/IEC
d. The Institution
A
What does 'DSMB' stand for?
A. Data Record Monitoring Board
b. Drug Statistics Measurement
Bureau
c. Drug Safety Monitoring Board
d. Data and Safety Monitoring Board
D
, In any trial, what should be the main concern of the physician?
A. The welfare of the subjects
b. Ensuring that the allotted quota of
subjects enrolled
c. The esteem that will be gained from a
successful trial outcome
d. The scientific outcome of the trial
A
The World Medical Association (WMA) ethical principles for medical research involving
human
subjects is called:
a. The International Research Act
b. The Belmont Report
c. The National Research Act
d. The Declaration of Helsinki
D
The process by which a subject voluntarily confirms his or her willingness to participate in a
clinical
trial is known as:
a. Intent to treat
b. Legally authorized agreement
c. Informed consent of trial subjects
d. IRB/IEC approval
C
One of the primary purposes of a Phase I study is to:
a. Demonstrate long term safety and efficacy
b. Determine he metabolic and pharmacologic action of the drug in humans
c. Demonstrate efficacy within the established safe dose range
d. Gather information on additional indications for the drug
B
What is the purpose of the 'Data and Safety Monitoring Board (DSMB)'?
A. To approve the trial protocol
b. To ensure that the monitor is performing his/her duties correctly
c. To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints
d. To ensure the accuracy of data and to carry out data analysis
C
. What does the IRB/IEC evaluate? (select all that apply)
a. The subject-selection procedure
EXAMS WITH A STUDY GUIDE AND KNOWLEDGE CHECK
FLASHCARDS WITH SUMMARIZED INSTRUCTOR NOTES
AT THE END FOR A GUARANTED PASS
Who is ultimately responsible for Source Data Verification (SDV)?
A. The coordinator
b. The subject
c. The monitor
d. The investigator
C
Every research study involving human subjects must be registered in a publicly accessible
database
before recruitment of the first subject.
A. True b. False
A
The Declaration of Helsinki was developed by:
a. The Nuremberg tribunal
b. The World Medical Association
c. The government of Finland
d. The American Medical Association
B
This phase determines therapeutic benefit and is usually done in a larger, specific population.
A. Phase 1
b. Phase 2
c. Phase 3
d. Phase 4
C
This phase begins after drug approval and explores therapeutic use:
a. Phase 1
b. Phase 2
c. Phase 3
d. Phase 4
D
This is the most typical study. Investigates human pharmacology. It is the initial administration
or an
investigational new drug into humans. It is most commonly done in healthy subjects.
,A. Phase 1
b. Phase 2
c. Phase 3
d. Phase 4
A
Providing a unified standard for Europe US, and Japan to facilitate the acceptance of clinical
trials is
the...
A. Mission statement of the ICH
b. Mission statement of the Declaration
of Helsinki
c. Mission statement of the GCP Guidelines
d. Mission statement of Canada Health
A
An investigator can be defined as... (Select all that apply)
a. A person responsible for the conduct of the clinical trial with the sponsor
b. A person responsible for writing the trial protocol
c. The responsible leader of the clinical research team at the site and may be called the
principal investigator
d. A person responsible for the conduct of the clinical trial at that site
C, d
A sub-investigator can be defined as...
A. The clinical research coordinator (CRC) or clinical trial nurse
b. Any individual member of the clinical trial team designated and supervised by the investigator
at a trial site to perform critical trial-related procedures and/or to make important trial-related
decisions
c. Any individual member of the clinical trial team supervised by the investigator at a trial site to
perform trial-related procedures
d. Any individual member of the clinical trial team that performs trial related duties
B
A sponsor can be defined as...
A. An individual who both initiates and conducts, alone or with others, a clinical trial
b. An individual who participates in a clinical trial
c. An individual or juridical or other body authorized under applicable law to consent to the
subject's participation in the clinical trial
d. An individual, company, institution, or organization which takes responsibility for the
initiation,
management, and/or financing a clinical trial
,D
What is the purpose of ICH-GCP?
A. To standardize the design, conduct, recording, and reporting of clinical trials
b. To instruct clinicians as to how to conduct preclinical toxicology tests
c. To ensure that subjects are treated with the best available therapy
d. To increase the number of abbreviations used in clinical practice
A
What is the purpose of the IRB/IEC?
A. To help ensure that trials are
conducted according to the protocol
b. To monitor clinical trials
c. To design trial protocols
d. To protect subject safety
D
According to ICH, the abbreviation 'LAR' stands for 'Legally authorized Representative'.
A. True b. False
B
What is the minimum number of members on an IRB/IEC?
A. 3
b. 5
c. 7
d. 8
B
Who is responsible for providing the trial protocol?
A. The sponsor
b. The investigator
c. The IRB/IEC
d. The Institution
A
What does 'DSMB' stand for?
A. Data Record Monitoring Board
b. Drug Statistics Measurement
Bureau
c. Drug Safety Monitoring Board
d. Data and Safety Monitoring Board
D
, In any trial, what should be the main concern of the physician?
A. The welfare of the subjects
b. Ensuring that the allotted quota of
subjects enrolled
c. The esteem that will be gained from a
successful trial outcome
d. The scientific outcome of the trial
A
The World Medical Association (WMA) ethical principles for medical research involving
human
subjects is called:
a. The International Research Act
b. The Belmont Report
c. The National Research Act
d. The Declaration of Helsinki
D
The process by which a subject voluntarily confirms his or her willingness to participate in a
clinical
trial is known as:
a. Intent to treat
b. Legally authorized agreement
c. Informed consent of trial subjects
d. IRB/IEC approval
C
One of the primary purposes of a Phase I study is to:
a. Demonstrate long term safety and efficacy
b. Determine he metabolic and pharmacologic action of the drug in humans
c. Demonstrate efficacy within the established safe dose range
d. Gather information on additional indications for the drug
B
What is the purpose of the 'Data and Safety Monitoring Board (DSMB)'?
A. To approve the trial protocol
b. To ensure that the monitor is performing his/her duties correctly
c. To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints
d. To ensure the accuracy of data and to carry out data analysis
C
. What does the IRB/IEC evaluate? (select all that apply)
a. The subject-selection procedure
