our answers to each question are listed below.

Your correct answers are in green

text and your incorrect answers are in red text. Please note that some questions
may not be graded. Those will appear in black text.
Question 1: True or False: The ICH defines informed consent as a process by which a
subject voluntarily confirms his or her willingness to participate in a trial,
after passing all protocol specific screening procedures.
Rationale: The correct answer is "False"
Your Answer: False
Question 2: Which of the following is NOT an element that is required in the
informed consent form?
Rationale: The correct answer is "Investigators responsibilities in conducting the
trial"
Your Answer: Investigators responsibilities in conducting the trial
Question 3: Which of the following should be considered when preparing an informed
consent document?
Rationale: The correct answer is "All of the above"
Your Answer: All of the above
Question 4: What elements might be included in the exchange of information during
informed consent?
Rationale: The correct answer is "Verbal instructions, written materials, and
opportunity to ask questions"
Your Answer: Verbal instructions, written materials, and opportunity to ask
questions
Question 5: True or False: If the investigator elects to delegate the
responsibility for informed consent to staff they must ensure that the staff is
knowledgeable regarding the study and able to answer questions.
Rationale: The correct answer is "True"
Your Answer: True
Question 6: Which of the following statements is true regarding informed consent in
emergency situations?
Rationale: The correct answer is "If the subject is unable to give consent and
there is no legal representative available a life saving study treatment may be
given, if there is no other alternative"
Your Answer: If the subject is unable to give consent and there is no legal
representative available a life saving study treatment may be given, if there is no
other alternative
Question 7: What is required in order for the investigator to deviate from the
protocol?
Rationale: The correct answer is "Agreement of the sponsor and approval/favorable
opinion of the IRB/IEC"
Your Answer: Approval of the sponsor and scientific rationale
Question 8: When is a deviation in protocol allowed without prior
approval/favorable opinion of the IRB/IEC?
Rationale: The correct answer is "When there is a need to eliminate an immediate
hazard to trial subjects"
Your Answer: When the investigator determines that the outcome data will not be
affected by the deviation
Question 9: True or False: The investigator is required to document only those
deviations from protocol that were not approved by the sponsor prior
implementation.
Rationale: The correct answer is "False"
Your Answer: False
Question 10: Which of the following is NOT an example of protocol non-compliance?
Rationale: The correct answer is "Failure to accrue agreed upon number of subjects"
Your Answer: Forgetting to document a dose of drug administered