Good Clinical Practice
A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic
neuropathy. While the study in ongoing, a new drug becomes commercially available
that may have equal or greater benefit to the subject. The investigator should do which
of the following.
A. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
B. Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subjects to decide whether to withdraw from the
research to take the new drug
C. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed
D. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients - ANS - B. Discuss the pros and cons of both the
investigational drug and the commercially available drug and the allow the subject to
decide whether to withdraw from the research to take the new drug.
A healthy volunteer is considering participating in a research study testing a new
vaccine for Ebola. He has left his glasses at home and he is unable to read the informed
consent form. According to ICH E6, who must be present during the discussion of
informed consent?
A. The qualified/principal investigator
B. A witness to signature
C. An impartial witness
D. The subject's legally acceptable representative (LAR) - ANS - C. An impartial
witness.
A monitor visits a site conducting a Phase III study for an investigational drug to treat
depression. The monitor is surprised to see so many improperly completed case report
forms (CRFs) by the study personnel. The monitor would likely take the following action:
A. Retrain, if necessary, the study coordinators on CRF filling procedures as outlines in
the protocol
B. Bring the matter to the IRB/IEC/REB
,C. Bring the matter to the regulatory authorities (for example, Health Canade and/or
FDA)
D. Fire the non-compliant study personnel, replacing them with others who will follow
the protocol - ANS - A. Retrain, if necessary, the study coordinates on CRF filling
procedures as outlines in the protocol.
A primary purpose of the ICH E6 guideline is to:
A. Require registration of clinical trials
B. Require publication of negative trial results
C. Develop mandatory worldwide regulations for drug development
D. Minimize the need for redundant research - ANS - D. Minimize the need for
redundant research.
A regulatory authority (for example, Health Canada or the FDA) sends a representative
to evaluate a trial in order to assure protection of research subjects, verify data, and
assure compliance with regulation. This is an example of:
A. Regulatory Inspection
B. Sponsor audit
C. Sponsor monitoring visit
D. IRB/IEC/REB review - ANS - A. Regulatory inspection.
A study subject breaks his leg in a skating accident. Is this incident a Serious Adverse
Event (SAE)?
A. Yes-only if the subject withdrew from the study
B. Yes-if the subject stayed in hospital overnight or had serious complications
C. No-it is not even an Adverse Event (AE)
D. No-it was not related to participation in the study - ANS - B. Yes- if the subject
stayed in hospital overnight or had serious complications.
A study subject reports that he has been having headaches for years but they seem to
have become more frequent since starting the study. The investigator believes this is
not related to the study medication. How would a clinical research coordinator document
this event?
A. This event would be a serious adverse event because the subject is taking part in a
research study
, B. This event does not require documentation because it is part of the study subject's
medical history
C. This even would be an adverse event because the complaint is more frequent
headaches since starting the study
D. This event would not be considered an adverse event, but it would be noted in the
subject's medial history form - ANS - C. This event would be an adverse event
because the complaint is more frequent headaches since starting the study.
According to a definition used in ICH E6, an individual (not a corporation or agency)
who both initiates and conduct, alone or with others, a clinical trial, and under whose
immediate direction the investigational product is administered to dispensed to, or used
by a research subject is a:
A. Principal Investigator
B. Sponsor-Investigator
C. Coordinating Investigator
D. Sponsor - ANS - B. Sponsor-Investigator
According to ICH E5, one purpose of effective study monitoring us to verify that:
A. Data are being recorded and collected electronically
B. The rights, safety, and well-being of all study subjects are being protected
C. The study is being conducted with the most up-to-date equipment available
D. The protocol is being loosely followed - ANS - B. The rights, safety, and well-being
of all study subjects are being protected.
According to ICH E6 Section 4.11.1, the investigator should notify the sponsor of
serious adverse events (SAE):
A. Within seven (7) days
B. At the next monitoring visit
C. When all the information about the SAE becomes available
D. As soon as possible after the investigator is aware of the SAE - ANS - D. As soon
as possible after the investigator is aware of the SAE.
According to ICH E6 the investigator should fulfill the following criteria: -Meet all the
qualification specified by the applicable regulatory requirements.
-Provide evidence of qualification through a Curriculum Vitae and other documentation
requested as applicable by the sponsor, the IRB/IEC/REB, regulatory authorities and
institution.
A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic
neuropathy. While the study in ongoing, a new drug becomes commercially available
that may have equal or greater benefit to the subject. The investigator should do which
of the following.
A. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
B. Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subjects to decide whether to withdraw from the
research to take the new drug
C. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed
D. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients - ANS - B. Discuss the pros and cons of both the
investigational drug and the commercially available drug and the allow the subject to
decide whether to withdraw from the research to take the new drug.
A healthy volunteer is considering participating in a research study testing a new
vaccine for Ebola. He has left his glasses at home and he is unable to read the informed
consent form. According to ICH E6, who must be present during the discussion of
informed consent?
A. The qualified/principal investigator
B. A witness to signature
C. An impartial witness
D. The subject's legally acceptable representative (LAR) - ANS - C. An impartial
witness.
A monitor visits a site conducting a Phase III study for an investigational drug to treat
depression. The monitor is surprised to see so many improperly completed case report
forms (CRFs) by the study personnel. The monitor would likely take the following action:
A. Retrain, if necessary, the study coordinators on CRF filling procedures as outlines in
the protocol
B. Bring the matter to the IRB/IEC/REB
,C. Bring the matter to the regulatory authorities (for example, Health Canade and/or
FDA)
D. Fire the non-compliant study personnel, replacing them with others who will follow
the protocol - ANS - A. Retrain, if necessary, the study coordinates on CRF filling
procedures as outlines in the protocol.
A primary purpose of the ICH E6 guideline is to:
A. Require registration of clinical trials
B. Require publication of negative trial results
C. Develop mandatory worldwide regulations for drug development
D. Minimize the need for redundant research - ANS - D. Minimize the need for
redundant research.
A regulatory authority (for example, Health Canada or the FDA) sends a representative
to evaluate a trial in order to assure protection of research subjects, verify data, and
assure compliance with regulation. This is an example of:
A. Regulatory Inspection
B. Sponsor audit
C. Sponsor monitoring visit
D. IRB/IEC/REB review - ANS - A. Regulatory inspection.
A study subject breaks his leg in a skating accident. Is this incident a Serious Adverse
Event (SAE)?
A. Yes-only if the subject withdrew from the study
B. Yes-if the subject stayed in hospital overnight or had serious complications
C. No-it is not even an Adverse Event (AE)
D. No-it was not related to participation in the study - ANS - B. Yes- if the subject
stayed in hospital overnight or had serious complications.
A study subject reports that he has been having headaches for years but they seem to
have become more frequent since starting the study. The investigator believes this is
not related to the study medication. How would a clinical research coordinator document
this event?
A. This event would be a serious adverse event because the subject is taking part in a
research study
, B. This event does not require documentation because it is part of the study subject's
medical history
C. This even would be an adverse event because the complaint is more frequent
headaches since starting the study
D. This event would not be considered an adverse event, but it would be noted in the
subject's medial history form - ANS - C. This event would be an adverse event
because the complaint is more frequent headaches since starting the study.
According to a definition used in ICH E6, an individual (not a corporation or agency)
who both initiates and conduct, alone or with others, a clinical trial, and under whose
immediate direction the investigational product is administered to dispensed to, or used
by a research subject is a:
A. Principal Investigator
B. Sponsor-Investigator
C. Coordinating Investigator
D. Sponsor - ANS - B. Sponsor-Investigator
According to ICH E5, one purpose of effective study monitoring us to verify that:
A. Data are being recorded and collected electronically
B. The rights, safety, and well-being of all study subjects are being protected
C. The study is being conducted with the most up-to-date equipment available
D. The protocol is being loosely followed - ANS - B. The rights, safety, and well-being
of all study subjects are being protected.
According to ICH E6 Section 4.11.1, the investigator should notify the sponsor of
serious adverse events (SAE):
A. Within seven (7) days
B. At the next monitoring visit
C. When all the information about the SAE becomes available
D. As soon as possible after the investigator is aware of the SAE - ANS - D. As soon
as possible after the investigator is aware of the SAE.
According to ICH E6 the investigator should fulfill the following criteria: -Meet all the
qualification specified by the applicable regulatory requirements.
-Provide evidence of qualification through a Curriculum Vitae and other documentation
requested as applicable by the sponsor, the IRB/IEC/REB, regulatory authorities and
institution.
