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CCRC Exam Prep Study Guide 2023 Graded A

CCRC Exam Prep Study Guide 2023 Graded A

CCRC Exam Prep Study Guide 2023
Graded A
What is an Adverse Event (AE) ? - Any untoward medical occurrence in a patient or
clinical investigation subject administered a pharmaceutical product and which does not
necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2)
What is an Adverse Drug Reaction (ADR)? - All noxious and unintended responses to a
medicinal product related to any dose. (ICH GCP E6 1.1)
What is the definition of Severity? - intensity
What are the criteria for a Serious Adverse Event? - Any event that:
(1) results in death;
(2) is life-threatening;
(3) results in inpatient hospitalization or prolongation of existing hospitalization;
(4) results in a persistent or significant disability/incapacity
(5) results in a congenital anomaly/birth defect; or
(6) based upon appropriate medical judgment, may jeopardize the subject's health and
may require medical or surgical intervention to prevent one of the other outcomes listed
above.
What is CRF characterized by? - A printed, optical, or electronic document designed to
record all of the protocol required information to be reported to the sponsor on each trial
subject
What are the different types of Comparators? - An investigational or marketed product
(i.e., active control), or placebo, used as a reference in a clinical trial.
Type I Error - Rejecting null hypothesis when it is true
Type II error - Failing to reject a false null hypothesis.
composite variables - If a single primary variable cannot be selected from multiple
measurements associated with the primary objective, another useful strategy is to
integrate or combine the multiple measurements into a single or composite variable,
using a pre-defined algorithm.
Role of IRB (Institutional Review Board) - safeguard the rights, safety, and well-being of
all trial subjects. Special attention should be paid to trials that may include vulnerable
subjects

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