CCRC 2024 CORRECT QUESTION AND ANSWERS
1. 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)
2. What is an Adverse Drug Reaction (ADR)?: All noxious and
unintended re- sponses to a medicinal product related to any dose.
(ICH GCP E6 1.1)
3. What is the definition of Severity?: intensity
4. 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 out- comes listed above.
5. 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
,6. 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.
7. Type I Error: Rejecting null hypothesis when it is true
8. Type II error: Failing to reject a false null hypothesis.
9. composite variables: If a single primary variable cannot be selected
from mul- tiple 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.
10.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
11.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.
12.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.
13.Phase III Clinical Trial: Testing of drug on patients to assess efficacy,
effective- ness 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.
14.Phase IV Clinical Trial: Post-marketing, continue assessing
therapeutic value and monitor less common adverse events
15.Nonclinical Study: Biomedical studies not performed on human
subjects. (ICH GCP E6 1.41)
16.double-dummy technique: -a technique used to maintain blinding
under con- ditions 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
17.Confirmatory Trial: Phase 3 trial during which the previously revealed
actions of a therapeutic intervention are confirmed
18.GCP: Good Clinical Practice, a standard for the conduct,
performance, mon- itoring, 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.
19.ICH: International Council on Harmonization
20.Declaration of Helsinki: The World Medical Association's international
ethical guidelines for medical professionals researching human subjects
21.ICH GCP E2a: Expedited reporting
22.IB: Investigator's Brochure, A compilation of the clinical and
1. 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)
2. What is an Adverse Drug Reaction (ADR)?: All noxious and
unintended re- sponses to a medicinal product related to any dose.
(ICH GCP E6 1.1)
3. What is the definition of Severity?: intensity
4. 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 out- comes listed above.
5. 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
,6. 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.
7. Type I Error: Rejecting null hypothesis when it is true
8. Type II error: Failing to reject a false null hypothesis.
9. composite variables: If a single primary variable cannot be selected
from mul- tiple 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.
10.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
11.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.
12.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.
13.Phase III Clinical Trial: Testing of drug on patients to assess efficacy,
effective- ness 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.
14.Phase IV Clinical Trial: Post-marketing, continue assessing
therapeutic value and monitor less common adverse events
15.Nonclinical Study: Biomedical studies not performed on human
subjects. (ICH GCP E6 1.41)
16.double-dummy technique: -a technique used to maintain blinding
under con- ditions 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
17.Confirmatory Trial: Phase 3 trial during which the previously revealed
actions of a therapeutic intervention are confirmed
18.GCP: Good Clinical Practice, a standard for the conduct,
performance, mon- itoring, 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.
19.ICH: International Council on Harmonization
20.Declaration of Helsinki: The World Medical Association's international
ethical guidelines for medical professionals researching human subjects
21.ICH GCP E2a: Expedited reporting
22.IB: Investigator's Brochure, A compilation of the clinical and
