ACRP CP Exam 1 Questions with Verified
Correct Answers
In any trial, what should be the main concern of the physician?
The welfare of the subjects
The world medical association (WMA) ethical principles for medical research involving
human subjects is called:
The Declaration of Helsinki
The process by which a subject voluntarily confirms his or her willingness to participate
in a clinical trial is known as:
Informed Consent of Trial Subjects
What does the IRB/IEC evaluate?
The scientific tenability of the trial, the subject-selection procedure, and the rights, safety,
and well being of the subjects participating in the trial
Which of the following documents is the investigator obliged to comply with during the
trial?
All applicable laws and regulations, ICH-GCP, and the trial protocol
What is the purpose of the initiation visit?
To review the protocol, to review the blank case report forms (CRFs), and to review standard
procedures
Who is ultimately responsible for Source Data Verification (SDV)?
The monitor
,Every research study involving human subjects must be registered in a publicly
accessible database before recruitment of the first subject (T/F).
True
The Declaration of Helsinki was developed by:
the WMA
This phase determines therapeutic benefit and is usually done in larger, specific
population:
Phase 3
Therapeutic use & begins after drug approval.
Phase 4
A sponsor can be defined as...
Phase 1
Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of
clinical trials is the..
Mission statement of the ICH
A sub-investigator can be defined as..
Any individual member of the clinical trial team designated and supervised by the
investigator of a trial site to perform clinical trial related procedures and/or to make important
trial related decisions
According to the principles of ICH GCP...
, 1. Clinical trials should be conducted in accordance with the ethical principles that have their
origin in the DoH and that are consistent with GCP and the applicable regulatory
requirement(s)
2. Before a trial is initiated, foreseeable risks and inconveniences should be weighted against
the anticipated benefit for the individual trial subject and society. A trial should be initiated
and continued only if the anticipated benefits justify the risks.
3. The available nonclinical and clinical info on an investigational product should be
adequate to support the proposed clinical trial
4. Clinical trials should be scientifically sound, and described in a clear, detailed protocol
Source data are..
All info in original records and certified copies of original records of critical findings,
observations, or other activities in a clinical trial necessary for the reconstruction and
evaluation of the trial
What is the purpose of the IRB/IEC?
To protect subject safety
Who is responsible for providing the trial protocol?
The sponsor
What does DSMB stand for?
Data and Safety Monitoring Board
One of the primary purposes of a Phase 1 study is to:
Determine the metabolic and pharmacologic action of the drug in humans
What is the purpose of the DSMB?
Correct Answers
In any trial, what should be the main concern of the physician?
The welfare of the subjects
The world medical association (WMA) ethical principles for medical research involving
human subjects is called:
The Declaration of Helsinki
The process by which a subject voluntarily confirms his or her willingness to participate
in a clinical trial is known as:
Informed Consent of Trial Subjects
What does the IRB/IEC evaluate?
The scientific tenability of the trial, the subject-selection procedure, and the rights, safety,
and well being of the subjects participating in the trial
Which of the following documents is the investigator obliged to comply with during the
trial?
All applicable laws and regulations, ICH-GCP, and the trial protocol
What is the purpose of the initiation visit?
To review the protocol, to review the blank case report forms (CRFs), and to review standard
procedures
Who is ultimately responsible for Source Data Verification (SDV)?
The monitor
,Every research study involving human subjects must be registered in a publicly
accessible database before recruitment of the first subject (T/F).
True
The Declaration of Helsinki was developed by:
the WMA
This phase determines therapeutic benefit and is usually done in larger, specific
population:
Phase 3
Therapeutic use & begins after drug approval.
Phase 4
A sponsor can be defined as...
Phase 1
Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of
clinical trials is the..
Mission statement of the ICH
A sub-investigator can be defined as..
Any individual member of the clinical trial team designated and supervised by the
investigator of a trial site to perform clinical trial related procedures and/or to make important
trial related decisions
According to the principles of ICH GCP...
, 1. Clinical trials should be conducted in accordance with the ethical principles that have their
origin in the DoH and that are consistent with GCP and the applicable regulatory
requirement(s)
2. Before a trial is initiated, foreseeable risks and inconveniences should be weighted against
the anticipated benefit for the individual trial subject and society. A trial should be initiated
and continued only if the anticipated benefits justify the risks.
3. The available nonclinical and clinical info on an investigational product should be
adequate to support the proposed clinical trial
4. Clinical trials should be scientifically sound, and described in a clear, detailed protocol
Source data are..
All info in original records and certified copies of original records of critical findings,
observations, or other activities in a clinical trial necessary for the reconstruction and
evaluation of the trial
What is the purpose of the IRB/IEC?
To protect subject safety
Who is responsible for providing the trial protocol?
The sponsor
What does DSMB stand for?
Data and Safety Monitoring Board
One of the primary purposes of a Phase 1 study is to:
Determine the metabolic and pharmacologic action of the drug in humans
What is the purpose of the DSMB?
