Mastery of CCRC Exam Prep Questions
and Answers.
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)
What is an IDMC? -
Independent Data Monitoring Committee, established by the sponsor to assess at
intervals the progress, the safety data, and the critical efficacy endpoints of a clinical
trial.
IRB composition -
(a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
Only those IRB/IEC members who are independent of the investigator and the sponsor
of the trial should vote/provide opinion on a trial-related matter.
A list of IRB/IEC members and their qualifications should be maintained.
Record retention IRB -
All relevant records (e.g., written procedures, membership lists, lists of
occupations/affiliations of members, submitted documents, minutes of meetings, and
correspondence) for a period of at least 3 years after completion of the trial and make
them available upon request from the regulatory authorities.
Can a PI notify a patient's primary care provider regarding participation in clinical trial? -
It is recommended that the investigator inform the subject's primary physician about the
subject's participation in the trial if the subject has a primary physician and if the subject
agrees to the primary physician being informed
What requirements must be met before an investigator can implement protocol
changes? -
The investigator should not implement any deviation from, or changes of, the protocol
without agreement by the sponsor and prior review and documented approval/favorable
and Answers.
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)
What is an IDMC? -
Independent Data Monitoring Committee, established by the sponsor to assess at
intervals the progress, the safety data, and the critical efficacy endpoints of a clinical
trial.
IRB composition -
(a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
Only those IRB/IEC members who are independent of the investigator and the sponsor
of the trial should vote/provide opinion on a trial-related matter.
A list of IRB/IEC members and their qualifications should be maintained.
Record retention IRB -
All relevant records (e.g., written procedures, membership lists, lists of
occupations/affiliations of members, submitted documents, minutes of meetings, and
correspondence) for a period of at least 3 years after completion of the trial and make
them available upon request from the regulatory authorities.
Can a PI notify a patient's primary care provider regarding participation in clinical trial? -
It is recommended that the investigator inform the subject's primary physician about the
subject's participation in the trial if the subject has a primary physician and if the subject
agrees to the primary physician being informed
What requirements must be met before an investigator can implement protocol
changes? -
The investigator should not implement any deviation from, or changes of, the protocol
without agreement by the sponsor and prior review and documented approval/favorable
