Good Clinical Practice Exam | Verified Exam Questions and Answers |
Latest Updated Study Material 2026
Question:
Which of the following are the three principles included in the Belmont Report?
Answer:
• Respect for Persons
Question:
• Beneficence
• Justice
Which of the following is an example of how the Principle of Beneficence can be applied to a
study employing human subjects?
Answer:
• Determining that the study
has maximized benefits and minimized risks.
Question:
* The Belmont Report's principle of beneficence includes the two general rules as
complementary expressions of beneficent actions (1) do not harm and (2) maximize possible
benefits and minimize possible harms. Providing detailed information about the study and
obtaining the subject's consent to participate would be an example of the principle of respect for
persons. Ensuring that the selection of subjects includes people from all segments of the
population would be an example of the principle of justice. Finally, ensuring that confidentiality
is maintained is a regulatory requirement per HHS regulations 45 CFR 46. Ensuring
confidentiality could be supported by respect for persons (extending the idea that the subject's
right to autonomy could include their right to privacy and confidentiality) and beneficence (that
maintaining privacy and confidentiality helps to protect subjects from potential harms of a
breach of confidentiality with sensitive information), but it is not the best response for this
question since it is not directly an example of the principle of beneficence in human subjects
research.
Which of the following best describes the principle of Respect for Persons as described in the
Belmont Report?
Answer:
• Information
,Question:
• Comprehension
• Voluntariness
* Respect for persons requires that subjects, to the degree that they are capable, be given the
opportunity to choose what shall or shall not happen to them. This opportunity is provided when
adequate standards for informed consent are satisfied. While the importance of informed consent
is unquestioned, controversy prevails over the nature and possibility of an informed consent.
Nonetheless, there is widespread agreement that the consent process can be analyzed as
containing three elements: information, comprehension and voluntariness.
In terms of explaining the probability of assignment to trial arms in consent forms, which is true?
Answer:
• ICH notes that it should be included, but does not specify how
the information should be presented.
Question:
* ICH (2016) E6 Section 4.8.10(c) states that "Both the informed consent discussion and the
written informed consent form and any other written information to be provided to subjects
should include the probability for random assignment to each treatment;" however, it does not
specify how the information should be presented. The FDA has no such requirement about
including probability for random assignment to each treatment, but does require an identification
of any procedures which are experimental. This difference can be addressed by including a
description of each arm of the study in the consent form, and including a statement about the
likelihood of receiving each of the study arms.
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage
quality throughout all stages of the trial process. The system should use a risk-based approach
including which of the following?
Answer:
• Identification of study risks
to determine which may safely be omitted from continual monitoring.
Question:
* ICH (2016) E6 Section 5.0.4 states that the sponsor should decide which risks to reduce and/or
which risks to accept. The approach used to reduce risk to an acceptable level should be
proportionate to the significance of the risk. Risk reduction activities may be incorporated in
protocol design and implementation, monitoring plans, and agreements. Routine scheduled
audits of study documentation whether on-site or remote are not considered fully responsive to
the need for continuous monitoring of data under a proactive risk-based approach. While data
from Case Report Forms may be selected for ongoing monitoring, there is no ICH template and a
, "one-size-fits-all" approach is not appropriate for study-specific monitoring. The use of any
specific method of analysis quality improvement is not required and routine annual review may
not be sufficient for monitoring the study-specific risks that have been identified.
What is the status of ICH in U.S.?
Answer:
• It is a FDA guidance
Question:
* After the ICH E6 guideline was finalized, several countries adopted it as law. In the United
States, however, the FDA adopted the ICH E6 only as guidance. Therefore, the ICH E6 guideline
does not have the force of law in the United States and is not a regulation. In the Federal Register
notice, FDA stated that the ICH E6 guideline "does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statutes, regulations, or both" (HHS
and FDA 1997, 25692). Therefore, compliance is voluntary, but as with any published FDA
guidance, compliance is considered part of good clinical practice.
Regarding subject receipt of a signed and dated copy of the consent forms, which is true about
FDA regulations?
Answer:
• The FDA regulations allow subjects or the
legally acceptable representatives (LARs) to receive either a signed or unsigned copy.
Question:
* The FDA regulations allow subjects to receive either a signed or unsigned copy. ICH E6
Section 4.8.11 requires that the subject or the legally acceptable representative (LAR) receive a
copy of the signed and dated written informed consent form. The FDA (1998) regulations allow
subjects to receive either a signed or unsigned copy. To be in compliance with ICH E6 guideline,
the investigator should include a statement in the consent form that the subject will receive a
signed and dated copy of the consent form. Persons obtaining consent must then ensure that this
procedure is followed.
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical
records and access by third parties. If investigators are complying with ICH E6 guideline, they
must:
Answer:
• Clearly disclose to subjects in the informed consent form
that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the
subject's medical records.
Latest Updated Study Material 2026
Question:
Which of the following are the three principles included in the Belmont Report?
Answer:
• Respect for Persons
Question:
• Beneficence
• Justice
Which of the following is an example of how the Principle of Beneficence can be applied to a
study employing human subjects?
Answer:
• Determining that the study
has maximized benefits and minimized risks.
Question:
* The Belmont Report's principle of beneficence includes the two general rules as
complementary expressions of beneficent actions (1) do not harm and (2) maximize possible
benefits and minimize possible harms. Providing detailed information about the study and
obtaining the subject's consent to participate would be an example of the principle of respect for
persons. Ensuring that the selection of subjects includes people from all segments of the
population would be an example of the principle of justice. Finally, ensuring that confidentiality
is maintained is a regulatory requirement per HHS regulations 45 CFR 46. Ensuring
confidentiality could be supported by respect for persons (extending the idea that the subject's
right to autonomy could include their right to privacy and confidentiality) and beneficence (that
maintaining privacy and confidentiality helps to protect subjects from potential harms of a
breach of confidentiality with sensitive information), but it is not the best response for this
question since it is not directly an example of the principle of beneficence in human subjects
research.
Which of the following best describes the principle of Respect for Persons as described in the
Belmont Report?
Answer:
• Information
,Question:
• Comprehension
• Voluntariness
* Respect for persons requires that subjects, to the degree that they are capable, be given the
opportunity to choose what shall or shall not happen to them. This opportunity is provided when
adequate standards for informed consent are satisfied. While the importance of informed consent
is unquestioned, controversy prevails over the nature and possibility of an informed consent.
Nonetheless, there is widespread agreement that the consent process can be analyzed as
containing three elements: information, comprehension and voluntariness.
In terms of explaining the probability of assignment to trial arms in consent forms, which is true?
Answer:
• ICH notes that it should be included, but does not specify how
the information should be presented.
Question:
* ICH (2016) E6 Section 4.8.10(c) states that "Both the informed consent discussion and the
written informed consent form and any other written information to be provided to subjects
should include the probability for random assignment to each treatment;" however, it does not
specify how the information should be presented. The FDA has no such requirement about
including probability for random assignment to each treatment, but does require an identification
of any procedures which are experimental. This difference can be addressed by including a
description of each arm of the study in the consent form, and including a statement about the
likelihood of receiving each of the study arms.
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage
quality throughout all stages of the trial process. The system should use a risk-based approach
including which of the following?
Answer:
• Identification of study risks
to determine which may safely be omitted from continual monitoring.
Question:
* ICH (2016) E6 Section 5.0.4 states that the sponsor should decide which risks to reduce and/or
which risks to accept. The approach used to reduce risk to an acceptable level should be
proportionate to the significance of the risk. Risk reduction activities may be incorporated in
protocol design and implementation, monitoring plans, and agreements. Routine scheduled
audits of study documentation whether on-site or remote are not considered fully responsive to
the need for continuous monitoring of data under a proactive risk-based approach. While data
from Case Report Forms may be selected for ongoing monitoring, there is no ICH template and a
, "one-size-fits-all" approach is not appropriate for study-specific monitoring. The use of any
specific method of analysis quality improvement is not required and routine annual review may
not be sufficient for monitoring the study-specific risks that have been identified.
What is the status of ICH in U.S.?
Answer:
• It is a FDA guidance
Question:
* After the ICH E6 guideline was finalized, several countries adopted it as law. In the United
States, however, the FDA adopted the ICH E6 only as guidance. Therefore, the ICH E6 guideline
does not have the force of law in the United States and is not a regulation. In the Federal Register
notice, FDA stated that the ICH E6 guideline "does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statutes, regulations, or both" (HHS
and FDA 1997, 25692). Therefore, compliance is voluntary, but as with any published FDA
guidance, compliance is considered part of good clinical practice.
Regarding subject receipt of a signed and dated copy of the consent forms, which is true about
FDA regulations?
Answer:
• The FDA regulations allow subjects or the
legally acceptable representatives (LARs) to receive either a signed or unsigned copy.
Question:
* The FDA regulations allow subjects to receive either a signed or unsigned copy. ICH E6
Section 4.8.11 requires that the subject or the legally acceptable representative (LAR) receive a
copy of the signed and dated written informed consent form. The FDA (1998) regulations allow
subjects to receive either a signed or unsigned copy. To be in compliance with ICH E6 guideline,
the investigator should include a statement in the consent form that the subject will receive a
signed and dated copy of the consent form. Persons obtaining consent must then ensure that this
procedure is followed.
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical
records and access by third parties. If investigators are complying with ICH E6 guideline, they
must:
Answer:
• Clearly disclose to subjects in the informed consent form
that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the
subject's medical records.
