ACRP CP Verified Exam Questions and Answers Latest update
2026/2027
Question:
Phase I
Answer:
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Question:
Who is ultimately responsible for all aspects of the research conducted at a site?
Answer:
Principal investigator
Question:
Define GCP
Answer:
An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials
and credibility of data
Question:
What event resulted in the Nuremburg Cod of 1949
Answer:
Nazi Medical Experiments
Question:
Which ICH Guideline is known as the GCP guideline?
Answer:
E6(R2)
Question:
What are the basic ethical principles of the Belmont Report?
Answer:
Beneficence, Respect for persons, Justice
, Question:
Define CBER, and full title
Answer:
Center for Biologics Evaluation and Research FDA center that regulates blood, vaccine, gene therapy
and tissue
Question:
What is the International Conference on Harmonization (ICH) Guidelines?
Answer:
A unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in
the European Union, Japan and United States.
Question:
To be a qualifying clinical trial, which three requirements must be met?
Answer:
Therapeutic Intent Enrolls patients with diagnosed disease Evaluates an item/service that falls within a
Medicare Benefit Category
Question:
Define informed consent
Answer:
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.
Question:
Primary purpose of IRB
Answer:
To ensure the protection of the rights and welfare of the human subjects
Question:
When can IRB waive informed consent?
Answer:
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
2026/2027
Question:
Phase I
Answer:
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Question:
Who is ultimately responsible for all aspects of the research conducted at a site?
Answer:
Principal investigator
Question:
Define GCP
Answer:
An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials
and credibility of data
Question:
What event resulted in the Nuremburg Cod of 1949
Answer:
Nazi Medical Experiments
Question:
Which ICH Guideline is known as the GCP guideline?
Answer:
E6(R2)
Question:
What are the basic ethical principles of the Belmont Report?
Answer:
Beneficence, Respect for persons, Justice
, Question:
Define CBER, and full title
Answer:
Center for Biologics Evaluation and Research FDA center that regulates blood, vaccine, gene therapy
and tissue
Question:
What is the International Conference on Harmonization (ICH) Guidelines?
Answer:
A unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in
the European Union, Japan and United States.
Question:
To be a qualifying clinical trial, which three requirements must be met?
Answer:
Therapeutic Intent Enrolls patients with diagnosed disease Evaluates an item/service that falls within a
Medicare Benefit Category
Question:
Define informed consent
Answer:
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.
Question:
Primary purpose of IRB
Answer:
To ensure the protection of the rights and welfare of the human subjects
Question:
When can IRB waive informed consent?
Answer:
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
