GOOD CLINICAL PRACTICE ICH
COMPREHENSIVE TEST 2026 QUESTIONS
WITH ANSWERS GRADED A+
◉ (select all that apply) The Declaration of Helsinki emphasizes the
importance of:
A. qualified researchers
B. structurally sound protocol
C. the prevention of torture
D. independent ethics committee review. Answer: A, B, and D
A. qualified researchers
B. structurally sound protocol
D. independent ethics committee review
◉ An investigational product should be stored between 0°C and -
20°C. Upon receipt, the temperature device indicates a maximum
temperature of -5°C. What should you do?
A. reject the product and return it to the sponsor
B. quarantine the product and contact the sponsor for instructions
,C. use the product. Answer:
◉ Who is responsible for notifying the regulatory authority if an
investigator/institution's participation in a trial is terminated for
noncompliance?
A. sponsor
B. monitor
C. investigator. Answer: A. sponsor
◉ Which of the following represents a vulnerable group requiring
additional IRB/IEC consideration?
A. women with type 1 diabetes mellitus
B. men with hypertension
C. women with advanced Alzheimer's dementia. Answer: C. women
with advanced Alzheimer's dementia
◉ Which of the following is consistent with the sponsor's duty to
determine roles and allocate trial-related activities?
A. validating product reconciliation software one month before drug
shipment
,B. developing and executing a vendor contract 6 months before the
first participant enrollment date
C. finalizing the monitoring plan 3 months after monitoring has
begun. Answer: A and B
A. validating product reconciliation software one month before drug
shipment
B. developing and executing a vendor contract 6 months before the
first participant enrollment date
◉ As an investigator, how should you obtain informed consent in a
trial enrolling mentally challenged adults?
A. inform the potential participant about the trial in a manner that
facilitates their understanding
B. the potential participant's legally authorized representative
should sign the informed consent form
C. the potential participant's caregiver should sign the informed
consent form
D. the potential participant should sign the informed consent form.
Answer: A and B
A. inform the potential participant about the trial in a manner that
facilitates their understanding
, B. the potential participant's legally authorized representative
should sign the informed consent form
◉ Which of the following is true?
A. a mentally ill adult may not be able to sign a legally binding
informed consent form
B. the potential participant should sign the informed consent form
after their eligibility is confirmed
C. the informed consent form must be written using scientific
terminology. Answer: A. a mentally ill adult may not be able to sign a
legally binding informed consent form
◉ Who bears ultimate responsibility for ensuring the rights, safety,
and well-being of clinical trial participants?
A. sponsor
B. sponsor, investigator, and IRB/IEC
C. investigator. Answer: C. investigator
◉ When can ethical principles in clinical trials be ignored?
A. only during a pandemic
COMPREHENSIVE TEST 2026 QUESTIONS
WITH ANSWERS GRADED A+
◉ (select all that apply) The Declaration of Helsinki emphasizes the
importance of:
A. qualified researchers
B. structurally sound protocol
C. the prevention of torture
D. independent ethics committee review. Answer: A, B, and D
A. qualified researchers
B. structurally sound protocol
D. independent ethics committee review
◉ An investigational product should be stored between 0°C and -
20°C. Upon receipt, the temperature device indicates a maximum
temperature of -5°C. What should you do?
A. reject the product and return it to the sponsor
B. quarantine the product and contact the sponsor for instructions
,C. use the product. Answer:
◉ Who is responsible for notifying the regulatory authority if an
investigator/institution's participation in a trial is terminated for
noncompliance?
A. sponsor
B. monitor
C. investigator. Answer: A. sponsor
◉ Which of the following represents a vulnerable group requiring
additional IRB/IEC consideration?
A. women with type 1 diabetes mellitus
B. men with hypertension
C. women with advanced Alzheimer's dementia. Answer: C. women
with advanced Alzheimer's dementia
◉ Which of the following is consistent with the sponsor's duty to
determine roles and allocate trial-related activities?
A. validating product reconciliation software one month before drug
shipment
,B. developing and executing a vendor contract 6 months before the
first participant enrollment date
C. finalizing the monitoring plan 3 months after monitoring has
begun. Answer: A and B
A. validating product reconciliation software one month before drug
shipment
B. developing and executing a vendor contract 6 months before the
first participant enrollment date
◉ As an investigator, how should you obtain informed consent in a
trial enrolling mentally challenged adults?
A. inform the potential participant about the trial in a manner that
facilitates their understanding
B. the potential participant's legally authorized representative
should sign the informed consent form
C. the potential participant's caregiver should sign the informed
consent form
D. the potential participant should sign the informed consent form.
Answer: A and B
A. inform the potential participant about the trial in a manner that
facilitates their understanding
, B. the potential participant's legally authorized representative
should sign the informed consent form
◉ Which of the following is true?
A. a mentally ill adult may not be able to sign a legally binding
informed consent form
B. the potential participant should sign the informed consent form
after their eligibility is confirmed
C. the informed consent form must be written using scientific
terminology. Answer: A. a mentally ill adult may not be able to sign a
legally binding informed consent form
◉ Who bears ultimate responsibility for ensuring the rights, safety,
and well-being of clinical trial participants?
A. sponsor
B. sponsor, investigator, and IRB/IEC
C. investigator. Answer: C. investigator
◉ When can ethical principles in clinical trials be ignored?
A. only during a pandemic
