GOOD CLINICAL PRACTICE ICH EXAM STUDY
GUIDE 2026 FULL QUESTIONS AND ANSWERS
GRADED A+
◉ The IRB/IEC should obtain which documents? Answer: Trial
protocol(s)/amendment(s). Written informed consent form(s) and
consent form updates that the investigator proposes for use in the
trial, Subject recruitment procedures (e.g., advertisements), Written
information to be provided to subjects, Investigator's Brochure (IB),
available safety information, information about payments and
compensation available to subjects, the investigator's current
curriculum vitae and/or other documentation evidencing
qualifications, and any other documents that the IRB/IEC may need
to fulfil its responsibilities
◉ The IRB/IEC should review a proposed clinical trial within a
reasonable time and document its views in writing, clearly
identifying the trial, the documents reviewed and the dates for the
following Answer: Approval/favourable opinion; modifications
required prior to its approval/favourable opinion; disapproval /
negative opinion; and termination/suspension of any prior
approval/favourable opinion.
◉ The IRB/IEC should consider the qualifications of the investigator
for the proposed trial, as documented by a current __________ and/or
,by any other relevant documentation the IRB/IEC requests. Answer:
CV
◉ The IRB/IEC should conduct continuing review of each ongoing
trial at intervals appropriate to the degree of risk to human subjects,
but at least _____________. Answer: once per year
◉ When would the IRB/IEC potentially request more information
than is outlined in paragraph 4.8.10 be given to subjects? Answer:
When, in the judgement of the IRB/IEC, the additional information
would add meaningfully to the protection of the rights, safety and/or
well-being of the subjects.
◉ When a non-therapeutic trial is to be carried out with the consent
of the subject's legally acceptable representative (see 4.8.12, 4.8.14),
what should the IRB/IEC do? Answer: Determine that the proposed
protocol and/or other document(s) adequately addresses relevant
ethical concerns and meets applicable regulatory requirements for
such trials.
◉ What should the IRB/IEC do when the protocol indicates that
prior consent of the trial subject or the subject's legally acceptable
representative is not possible (see 4.8.15)? Answer: The IRB/IEC
should determine that the proposed protocol and/or other
document(s) adequately addresses relevant ethical concerns and
meets applicable regulatory requirements for such trials (i.e., in
emergency situations).
,◉ The IRB/IEC should review both the ________ and _________ of
payment to subjects to assure that neither presents problems of
_________ or ___________ on the trial subjects. Payments to a subject
should be ___________ and _____ wholly contingent on completion of the
trial by the subject. Answer: amount, method. coercion, undue
influence. prorated, not.
◉ The IRB/IEC should ensure that information regarding payment
to subjects, including the methods, amounts, schedule of payment to
trial subjects, and the way payment will be prorated should be set
forth in what document? Answer: Written Informed Consent Form
and any other written information to be provided to subjects.
◉ The IRB/IEC should consist of a reasonable number of members,
who collectively have the ______________ and ____________ to review and
evaluate the science, medical aspects, and ethics of the proposed
trial. Answer: qualifications and experience
◉ It is recommended that the IRB/IEC should include:
(a) At least ______ members
(b) At least ______ member whose primary area of interest is in a
______________ area
(c) At least _______ member who is ______________ of the
institution/trial site. Answer: a) 5
, b) 1, nonscientific
c) 1, independent
◉ Which IRB/IEC members should vote/provide opinion on a trial-
related matter? Answer: Only those members who are independent
of the investigator and the sponsor of the trial
◉ True or False: A list of IRB/IEC members and their qualifications
should be maintained. Answer: True
◉ The IRB/IEC should:
- perform its functions according to __________________.
- should maintain written records of its activities and minutes of its
__________.
- should comply with ______ and with the applicable
______________________________. Answer: - written operating procedures
- meetings
- GCP, Regulatory requirements
◉ When should an IRB/IEC make its decisions? Answer: At
announced meetings at which at least a quorum, as stipulated in its
written operating procedures, is present.
GUIDE 2026 FULL QUESTIONS AND ANSWERS
GRADED A+
◉ The IRB/IEC should obtain which documents? Answer: Trial
protocol(s)/amendment(s). Written informed consent form(s) and
consent form updates that the investigator proposes for use in the
trial, Subject recruitment procedures (e.g., advertisements), Written
information to be provided to subjects, Investigator's Brochure (IB),
available safety information, information about payments and
compensation available to subjects, the investigator's current
curriculum vitae and/or other documentation evidencing
qualifications, and any other documents that the IRB/IEC may need
to fulfil its responsibilities
◉ The IRB/IEC should review a proposed clinical trial within a
reasonable time and document its views in writing, clearly
identifying the trial, the documents reviewed and the dates for the
following Answer: Approval/favourable opinion; modifications
required prior to its approval/favourable opinion; disapproval /
negative opinion; and termination/suspension of any prior
approval/favourable opinion.
◉ The IRB/IEC should consider the qualifications of the investigator
for the proposed trial, as documented by a current __________ and/or
,by any other relevant documentation the IRB/IEC requests. Answer:
CV
◉ The IRB/IEC should conduct continuing review of each ongoing
trial at intervals appropriate to the degree of risk to human subjects,
but at least _____________. Answer: once per year
◉ When would the IRB/IEC potentially request more information
than is outlined in paragraph 4.8.10 be given to subjects? Answer:
When, in the judgement of the IRB/IEC, the additional information
would add meaningfully to the protection of the rights, safety and/or
well-being of the subjects.
◉ When a non-therapeutic trial is to be carried out with the consent
of the subject's legally acceptable representative (see 4.8.12, 4.8.14),
what should the IRB/IEC do? Answer: Determine that the proposed
protocol and/or other document(s) adequately addresses relevant
ethical concerns and meets applicable regulatory requirements for
such trials.
◉ What should the IRB/IEC do when the protocol indicates that
prior consent of the trial subject or the subject's legally acceptable
representative is not possible (see 4.8.15)? Answer: The IRB/IEC
should determine that the proposed protocol and/or other
document(s) adequately addresses relevant ethical concerns and
meets applicable regulatory requirements for such trials (i.e., in
emergency situations).
,◉ The IRB/IEC should review both the ________ and _________ of
payment to subjects to assure that neither presents problems of
_________ or ___________ on the trial subjects. Payments to a subject
should be ___________ and _____ wholly contingent on completion of the
trial by the subject. Answer: amount, method. coercion, undue
influence. prorated, not.
◉ The IRB/IEC should ensure that information regarding payment
to subjects, including the methods, amounts, schedule of payment to
trial subjects, and the way payment will be prorated should be set
forth in what document? Answer: Written Informed Consent Form
and any other written information to be provided to subjects.
◉ The IRB/IEC should consist of a reasonable number of members,
who collectively have the ______________ and ____________ to review and
evaluate the science, medical aspects, and ethics of the proposed
trial. Answer: qualifications and experience
◉ It is recommended that the IRB/IEC should include:
(a) At least ______ members
(b) At least ______ member whose primary area of interest is in a
______________ area
(c) At least _______ member who is ______________ of the
institution/trial site. Answer: a) 5
, b) 1, nonscientific
c) 1, independent
◉ Which IRB/IEC members should vote/provide opinion on a trial-
related matter? Answer: Only those members who are independent
of the investigator and the sponsor of the trial
◉ True or False: A list of IRB/IEC members and their qualifications
should be maintained. Answer: True
◉ The IRB/IEC should:
- perform its functions according to __________________.
- should maintain written records of its activities and minutes of its
__________.
- should comply with ______ and with the applicable
______________________________. Answer: - written operating procedures
- meetings
- GCP, Regulatory requirements
◉ When should an IRB/IEC make its decisions? Answer: At
announced meetings at which at least a quorum, as stipulated in its
written operating procedures, is present.
