Phase I -Correct 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? -Correct Answer Principal investigator
Define GCP -Correct Answer An international quality st...
ACRP CP Test Questions and Answers
2024 Graded A
Phase I -Correct 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? -
Correct Answer ✔Principal investigator
Define GCP -Correct 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 -Correct Answer ✔Nazi Medical
Experiments
Which ICH Guideline is known as the GCP guideline? -Correct Answer ✔E6(R2)
What are the basic ethical principles of the Belmont Report? -Correct Answer
✔Beneficence, Respect for persons, Justice
Define CBER, and full title -Correct 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? -Correct
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? -Correct Answer
✔Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit Category
Define informed consent -Correct 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 -Correct Answer ✔To ensure the protection of the rights and
welfare of the human subjects
ACRP-CP Exam
, ACRP-CP Exam
When can IRB waive informed consent? -Correct 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
application); is valid one year; and must be updated within ___ days of taking effect. -
Correct Answer ✔30, 60
Phase II -Correct Answer ✔Focuses primarily on safety and effectiveness, is dose-
ranging and occurs in subjects with the disease or condition.
After the New Drug Application is approved, the responsibility for reporting safety issues
to the FDA rests with -Correct Answer ✔The sponsor
To whom may a sponsor transfer its responsibility for any or all of its clinical trial
obligations? -Correct Answer ✔Contract Research Organization
Define role of CDRH and abbreviation -Correct Answer ✔Center for Devices and
Radiological Health
FDA center that assures that patients and providers have timely and continued access
to safe, effective, and high-quality medical devices and safe radiation-emitting products.
Define Adverse Drug reaction -Correct Answer ✔all noxious and unintended response
to a medicinal product related to any dose.
How many days does a sponsor have to report non-fatal IND safety report to the FDA -
Correct Answer ✔15 calendar days
What are examples of hidden costs in a study budget -Correct Answer ✔Unexpected
equipment failure
Four types of monitoring visits are: -Correct Answer ✔Qualification, Initiation, Routine,
Close-out
Define Protocol -Correct Answer ✔A document that describes the objective(s), design,
methodology, statistical considerations and organization of a trial.
ACRP-CP Exam
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