Good Clinical Practice Exam | Verified Exam Questions and Answers |
Latest Updated Study Material 2026
Question:
The ICH E6 guideline should be followed when:
A. Generating clinical trial data that are intended to be submitted to regulatory authorities
B. Conducting studies under a U.S. Investigational New Drug (IND) application or
Investigational Device Exemption (IDE)
C. Generating quality improvement and quality assurance data
D. Conducting device studies under a Canadian Investigational Testing Authorization (ITA)
Answer:
A. Generating clinical trial data that are intended to be submitted
to regulatory authorities.
Question:
ICH E6 describes standards that apply to:
A. Research
B. IRBs only
C. Investigators, sponsors, Institutional Review Board (IRBs) / Independent Ethics Committees
(IECs) / Research Ethics Boards (REBs)
D. Investigators only
Answer:
C. Investigators, sponsors, and
Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics
Boards (REBs).
Question:
ICH topics and guidelines fall into four main categories:
A. Sponsor, Investigator, Statistical Analysis, Trial Management
B. Quality, Safety, Efficacy, Multidisciplinary
C. Sponsor, Investigator, Statistical Analysis, Research Ethics
D. Quality, Security, Efficiency, Multidisciplinary
,Answer:
B. Quality,
Safety, Multidisciplinary.
Question:
The two important goals of the ICH E6 standard are:
A. To assure that sponsors select sites based on qualifications; to assure that data are reported on
time
B. To assure that the rights, well-being, and confidentiality of trial subjects are protected; to
assure that data are reported on time
C. To assure that the rights, well-being, and confidentiality of trial subjects are protected; to
assure that trial data are credible
D. To assure that all patients have access to a clinical trial; to assure that the trial data are
credible
Answer:
C. To assure that the rights, well-being, and
confidentiality of trial subjects are protected; to assure that trial data are credible.
Question:
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
Answer:
D. Minimize the
need for redundant research.
Question:
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
Answer:
D. As soon as possible after the investigator is aware of the SAE.
Question:
Delegation of study-related tasks by the qualifies/principal investigator to other study team
members (for example, completion of the Case Report Form [CRF]) is permitted, provided that:
A. The task occurs in the screening phase of the study rather than the treatment phase
B. The qualified/principal investigator is not available to carry out the task
C. The individual has been trained/experienced in the task and has signed the task delegation log
D. The individual has signed the task delegation log
Answer:
C. The
individual has been trained/experienced in the task and has signed the task delegation log.
Question:
Which of the following statements appears in ICH E6 Section 4.2 entitled "Adequate
Resources?"
A. The investigator is not obliged to demonstrate a potential for recruiting the required number
of suitable research subjects withing the agrees recruitment period.
B. The investigator should have sufficient time to properly conduct and complete the research
study, even if this exceeds the agreed trial period
C. The sponsor is responsible for ensuring that the investigator has an adequate number of
qualified staff, sufficient time and adequate facilities available at all times for the duration of the
study
D. The investigator should ensure that all persons assisting with the trial are adequately informed
about the protocol , the investigational product(s), and their trial-related duties and functions
Answer:
D. The investigstor should ensure that all persons assisting the
with the trial are adequately informed about the protocol, the investigational product(s), and their
trial-related duties and functions.
Question:
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
Latest Updated Study Material 2026
Question:
The ICH E6 guideline should be followed when:
A. Generating clinical trial data that are intended to be submitted to regulatory authorities
B. Conducting studies under a U.S. Investigational New Drug (IND) application or
Investigational Device Exemption (IDE)
C. Generating quality improvement and quality assurance data
D. Conducting device studies under a Canadian Investigational Testing Authorization (ITA)
Answer:
A. Generating clinical trial data that are intended to be submitted
to regulatory authorities.
Question:
ICH E6 describes standards that apply to:
A. Research
B. IRBs only
C. Investigators, sponsors, Institutional Review Board (IRBs) / Independent Ethics Committees
(IECs) / Research Ethics Boards (REBs)
D. Investigators only
Answer:
C. Investigators, sponsors, and
Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics
Boards (REBs).
Question:
ICH topics and guidelines fall into four main categories:
A. Sponsor, Investigator, Statistical Analysis, Trial Management
B. Quality, Safety, Efficacy, Multidisciplinary
C. Sponsor, Investigator, Statistical Analysis, Research Ethics
D. Quality, Security, Efficiency, Multidisciplinary
,Answer:
B. Quality,
Safety, Multidisciplinary.
Question:
The two important goals of the ICH E6 standard are:
A. To assure that sponsors select sites based on qualifications; to assure that data are reported on
time
B. To assure that the rights, well-being, and confidentiality of trial subjects are protected; to
assure that data are reported on time
C. To assure that the rights, well-being, and confidentiality of trial subjects are protected; to
assure that trial data are credible
D. To assure that all patients have access to a clinical trial; to assure that the trial data are
credible
Answer:
C. To assure that the rights, well-being, and
confidentiality of trial subjects are protected; to assure that trial data are credible.
Question:
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
Answer:
D. Minimize the
need for redundant research.
Question:
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
Answer:
D. As soon as possible after the investigator is aware of the SAE.
Question:
Delegation of study-related tasks by the qualifies/principal investigator to other study team
members (for example, completion of the Case Report Form [CRF]) is permitted, provided that:
A. The task occurs in the screening phase of the study rather than the treatment phase
B. The qualified/principal investigator is not available to carry out the task
C. The individual has been trained/experienced in the task and has signed the task delegation log
D. The individual has signed the task delegation log
Answer:
C. The
individual has been trained/experienced in the task and has signed the task delegation log.
Question:
Which of the following statements appears in ICH E6 Section 4.2 entitled "Adequate
Resources?"
A. The investigator is not obliged to demonstrate a potential for recruiting the required number
of suitable research subjects withing the agrees recruitment period.
B. The investigator should have sufficient time to properly conduct and complete the research
study, even if this exceeds the agreed trial period
C. The sponsor is responsible for ensuring that the investigator has an adequate number of
qualified staff, sufficient time and adequate facilities available at all times for the duration of the
study
D. The investigator should ensure that all persons assisting with the trial are adequately informed
about the protocol , the investigational product(s), and their trial-related duties and functions
Answer:
D. The investigstor should ensure that all persons assisting the
with the trial are adequately informed about the protocol, the investigational product(s), and their
trial-related duties and functions.
Question:
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
