CCRC Exam Prep Test
What is an Adverse Event (AE) ? - answer 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)? - answer All noxious and unintended
responses to a medicinal product related to any dose. (ICH GCP E6 1.1)
What is the definition of Severity? - answer intensity
What are the criteria for a Serious Adverse Event? - answer 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? - answerA 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? - answerAn investigational or marketed
product (i.e., active control), or placebo, used as a reference in a clinical trial.
Type I Error - answerRejecting null hypothesis when it is true
Type II error - answerFailing to reject a false null hypothesis.
composite variables - answerIf 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) - answersafeguard the rights, safety, and well-
being of all trial subjects. Special attention should be paid to trials that may include
vulnerable subjects
,Phase I - answerInitial 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 - answerThe 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 - answerTesting 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 - answerPost-marketing, continue assessing therapeutic value
and monitor less common adverse events
Nonclinical Study - answerBiomedical studies not performed on human subjects. (ICH
GCP E6 1.41)
double-dummy technique - answer-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 - answerPhase 3 trial during which the previously revealed actions of
a therapeutic intervention are confirmed
GCP - answerGood 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 - answerInternational Council on Harmonization
Declaration of Helsinki - answerThe World Medical Association's international ethical
guidelines for medical professionals researching human subjects
ICH GCP E2a - answerExpedited reporting
IB - answerInvestigator'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? - answerIndependent 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 - answer(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 - answerAll 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? -
answerIt 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? - answerThe investigator should not implement any deviation from, or
changes of, the protocol without agreement by the sponsor and prior review and
documented approval/favorable opinion from the IRB/IEC of an amendment, except
where necessary to eliminate an immediate hazard(s) to trial subjects, or when the
change(s) involves only logistical or administrative aspects of the trial (e.g., change in
monitor(s), change of telephone number(s)).
What an investigator must do in the event of accidental unblinding - answerThe
investigator should follow the trial's randomization procedures, if any, and should ensure
that the code is broken only in accordance with the protocol. If the trial is blinded, the
investigator should promptly document and explain to the sponsor any premature
unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the
investigational product(s)
Protocol language cannot.... - answerContain any language that causes the subject or
the subject's legally acceptable representative to waive or to appear to waive any legal
rights, or that releases or appears to release the investigator, the institution, the
sponsor, or their agents from liability for negligence.
When can an investigator deviate from the protocol? - answerThe investigator may
implement a deviation from, or a change in, the protocol to eliminate an immediate
hazard(s) to trial subjects without prior IRB/IEC approval/favorable opinion. As soon as
What is an Adverse Event (AE) ? - answer 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)? - answer All noxious and unintended
responses to a medicinal product related to any dose. (ICH GCP E6 1.1)
What is the definition of Severity? - answer intensity
What are the criteria for a Serious Adverse Event? - answer 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? - answerA 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? - answerAn investigational or marketed
product (i.e., active control), or placebo, used as a reference in a clinical trial.
Type I Error - answerRejecting null hypothesis when it is true
Type II error - answerFailing to reject a false null hypothesis.
composite variables - answerIf 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) - answersafeguard the rights, safety, and well-
being of all trial subjects. Special attention should be paid to trials that may include
vulnerable subjects
,Phase I - answerInitial 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 - answerThe 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 - answerTesting 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 - answerPost-marketing, continue assessing therapeutic value
and monitor less common adverse events
Nonclinical Study - answerBiomedical studies not performed on human subjects. (ICH
GCP E6 1.41)
double-dummy technique - answer-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 - answerPhase 3 trial during which the previously revealed actions of
a therapeutic intervention are confirmed
GCP - answerGood 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 - answerInternational Council on Harmonization
Declaration of Helsinki - answerThe World Medical Association's international ethical
guidelines for medical professionals researching human subjects
ICH GCP E2a - answerExpedited reporting
IB - answerInvestigator'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? - answerIndependent 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 - answer(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 - answerAll 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? -
answerIt 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? - answerThe investigator should not implement any deviation from, or
changes of, the protocol without agreement by the sponsor and prior review and
documented approval/favorable opinion from the IRB/IEC of an amendment, except
where necessary to eliminate an immediate hazard(s) to trial subjects, or when the
change(s) involves only logistical or administrative aspects of the trial (e.g., change in
monitor(s), change of telephone number(s)).
What an investigator must do in the event of accidental unblinding - answerThe
investigator should follow the trial's randomization procedures, if any, and should ensure
that the code is broken only in accordance with the protocol. If the trial is blinded, the
investigator should promptly document and explain to the sponsor any premature
unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the
investigational product(s)
Protocol language cannot.... - answerContain any language that causes the subject or
the subject's legally acceptable representative to waive or to appear to waive any legal
rights, or that releases or appears to release the investigator, the institution, the
sponsor, or their agents from liability for negligence.
When can an investigator deviate from the protocol? - answerThe investigator may
implement a deviation from, or a change in, the protocol to eliminate an immediate
hazard(s) to trial subjects without prior IRB/IEC approval/favorable opinion. As soon as
