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
Phase I - Initial clinical safety studies in humans. May be as few as 10 subjects, often
healthy volunteers, includes PK, ADME and dose escalation studies. Usually open
label.
Phase II - The study drug or treatment is given to a larger group of people (100-300) to
see if it is effective and to further evaluate its safety.
Phase III Clinical Trial - Testing of drug on patients to assess efficacy, effectiveness and
safety (usually multi-center trials on a much larger patient groups).
The drug or treatment is given to large groups of people
to confirm its effectiveness, monitor side effects, compare it to commonly used
treatments, and collect information that will allow the drug or treatment to be used
safely.
Phase IV Clinical Trial - Post-marketing, continue assessing therapeutic value and
monitor less common adverse events
Nonclinical Study - Biomedical studies not performed on human subjects. (ICH GCP E6
1.41)
double-dummy technique - -a technique used to maintain blinding under conditions in
which treatments differ, such as by route of administration
-it consists of preparing both treatment and placebo (or an alternative treatment) in such
a manner that such cues do not identify the treatment
Confirmatory Trial - Phase 3 trial during which the previously revealed actions of a
therapeutic intervention are confirmed
GCP - Good Clinical Practice, a standard for the conduct, performance, monitoring,
auditing, recording, analyses, and reporting of clinical trials that provides assurance that
the data and reported results are credible and accurate, and that the rights, integrity,
and confidentiality of trial subjects are protected.
ICH - International Council on Harmonization
Declaration of Helsinki - The World Medical Association's international ethical guidelines
for medical professionals researching human subjects
ICH GCP E2a - Expedited reporting
IB - Investigator's Brochure, A compilation of the clinical and nonclinical data on the
investigational products which is relevant to the study of the investigational products in
human subjects. (ICH GCP E6 1.36)