ACRP CP WITH DETAILED QUESTIONS
AND VERIFIED ANSWERS ALREADY
GRADED A
Phase I - ANSWER>>>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? - ANSWER>>>Principal investigator
Define GCP - ANSWER>>>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 -
ANSWER>>>Nazi Medical Experiments
Which ICH Guideline is known as the GCP guideline? -
ANSWER>>>E6(R2)
What are the basic ethical principles of the Belmont Report? -
ANSWER>>>Beneficence, Respect for persons, Justice
Define CBER, and full title - ANSWER>>>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? - ANSWER>>>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? - ANSWER>>>Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit
Category
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.
Primary purpose of IRB - ANSWER>>>To ensure the
protection of the rights and welfare of the human subjects
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
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
AND VERIFIED ANSWERS ALREADY
GRADED A
Phase I - ANSWER>>>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? - ANSWER>>>Principal investigator
Define GCP - ANSWER>>>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 -
ANSWER>>>Nazi Medical Experiments
Which ICH Guideline is known as the GCP guideline? -
ANSWER>>>E6(R2)
What are the basic ethical principles of the Belmont Report? -
ANSWER>>>Beneficence, Respect for persons, Justice
Define CBER, and full title - ANSWER>>>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? - ANSWER>>>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? - ANSWER>>>Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit
Category
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.
Primary purpose of IRB - ANSWER>>>To ensure the
protection of the rights and welfare of the human subjects
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
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
