ACRP CP UPDATED Questions and
CORRECT Answers
Phase I - CORRECT ANSWERS 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? - CORRECT
ANSWERS Principal investigator
Define GCP - CORRECT ANSWERS 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 - CORRECT ANSWERS Nazi
Medical Experiments
Which ICH Guideline is known as the GCP guideline? - CORRECT ANSWERS E6(R2)
What are the basic ethical principles of the Belmont Report? - CORRECT
ANSWERS Beneficence, Respect for persons, Justice
Define CBER, and full title - CORRECT ANSWERS 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? - CORRECT
ANSWERS 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? - CORRECT
ANSWERS Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit Category
Define informed consent - CORRECT ANSWERS 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 - CORRECT ANSWERS To ensure the protection of the rights
and welfare of the human subjects
When can IRB waive informed consent? - CORRECT ANSWERS 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. - CORRECT
ANSWERS 30, 60
Phase II - CORRECT ANSWERS Focuses primarily on safety and effectiveness, is dose-
ranging and occurs in subjects with the disease or condition.
Quality documentation practices ALCOAC stands for - CORRECT
ANSWERS Attributable, Legible, Contemporaneous, Original, Accurate, Complete
After the New Drug Application is approved, the responsibility for reporting safety issues to the
FDA rests with - CORRECT ANSWERS The sponsor
CORRECT Answers
Phase I - CORRECT ANSWERS 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? - CORRECT
ANSWERS Principal investigator
Define GCP - CORRECT ANSWERS 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 - CORRECT ANSWERS Nazi
Medical Experiments
Which ICH Guideline is known as the GCP guideline? - CORRECT ANSWERS E6(R2)
What are the basic ethical principles of the Belmont Report? - CORRECT
ANSWERS Beneficence, Respect for persons, Justice
Define CBER, and full title - CORRECT ANSWERS 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? - CORRECT
ANSWERS 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? - CORRECT
ANSWERS Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit Category
Define informed consent - CORRECT ANSWERS 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 - CORRECT ANSWERS To ensure the protection of the rights
and welfare of the human subjects
When can IRB waive informed consent? - CORRECT ANSWERS 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. - CORRECT
ANSWERS 30, 60
Phase II - CORRECT ANSWERS Focuses primarily on safety and effectiveness, is dose-
ranging and occurs in subjects with the disease or condition.
Quality documentation practices ALCOAC stands for - CORRECT
ANSWERS Attributable, Legible, Contemporaneous, Original, Accurate, Complete
After the New Drug Application is approved, the responsibility for reporting safety issues to the
FDA rests with - CORRECT ANSWERS The sponsor
