ACRP CP Test Questions with Verified Correct
Answers
Phase I
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the research conducted at a site?
Principal investigator
Define GCP
An international quality standard that is provided by ICH E6(R2) describing safety, accuracy
of trials and credibility of data
What event resulted in the Nuremburg Cod of 1949
Nazi Medical Experiments
Which ICH Guideline is known as the GCP guideline?
E6(R2)
What are the basic ethical principles of the Belmont Report?
Beneficence, Respect for persons, Justice
Define CBER, and full title
Center for Biologics Evaluation and Research
FDA center that regulates blood, vaccine, gene therapy and tissue
What is the International Conference on Harmonization (ICH) Guidelines?
, A unified standard to facilitate the mutual acceptance of clinical data by the regulatory
authorities in the European Union, Japan and United States.
To be a qualifying clinical trial, which three requirements must be met?
Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit Category
Define informed consent
A process by which a subject voluntarily confirms his or her willingness to participate in a
particular trial, after having been informed of all aspects of the trial that are relevant to the
subjects decision to participate.
Primary purpose of IRB
To ensure the protection of the rights and welfare of the human subjects
When can IRB waive informed consent?
IRB has the ability to waive the informed consent requirement if the research is no more than
minimal risk and involves no procedures for which consent is required outside of the research
context and in emergency research
An investigational New Drug (IND) Application becomes effective ___ days after receipt
by the FDA (barring a hold, request for additional information, or rejection of an
application); is valid one year; and must be updated within ___ days of taking effect.
30, 60
Phase II
Answers
Phase I
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the research conducted at a site?
Principal investigator
Define GCP
An international quality standard that is provided by ICH E6(R2) describing safety, accuracy
of trials and credibility of data
What event resulted in the Nuremburg Cod of 1949
Nazi Medical Experiments
Which ICH Guideline is known as the GCP guideline?
E6(R2)
What are the basic ethical principles of the Belmont Report?
Beneficence, Respect for persons, Justice
Define CBER, and full title
Center for Biologics Evaluation and Research
FDA center that regulates blood, vaccine, gene therapy and tissue
What is the International Conference on Harmonization (ICH) Guidelines?
, A unified standard to facilitate the mutual acceptance of clinical data by the regulatory
authorities in the European Union, Japan and United States.
To be a qualifying clinical trial, which three requirements must be met?
Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit Category
Define informed consent
A process by which a subject voluntarily confirms his or her willingness to participate in a
particular trial, after having been informed of all aspects of the trial that are relevant to the
subjects decision to participate.
Primary purpose of IRB
To ensure the protection of the rights and welfare of the human subjects
When can IRB waive informed consent?
IRB has the ability to waive the informed consent requirement if the research is no more than
minimal risk and involves no procedures for which consent is required outside of the research
context and in emergency research
An investigational New Drug (IND) Application becomes effective ___ days after receipt
by the FDA (barring a hold, request for additional information, or rejection of an
application); is valid one year; and must be updated within ___ days of taking effect.
30, 60
Phase II
