ICH E6(R2) - Good Clinical Practice Exam | Verified Exam Questions and Answers | Latest Updated Study Material 2026

ICH E6(R2) - Good Clinical Practice Exam | Verified Exam Questions and
Answers | Latest Updated Study Material 2026

Question:

ICH E6(R2) - Good Clinical Practice Exam | Comprehensive
An IRB/IEC should safeguard the , , and of all trial subjects. Special
attention should be paid to trials that may include subjects.
Answer:

Rights, safety, and well being. Vulnerable.

Question:

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

Question:

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.

Question:

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

,Question:

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

Question:

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.

Question:

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.

Question:

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).

Question:

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.

,Question:

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.

Question:

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

Question:

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

Question:

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

Question:

True or False: A list of IRB/IEC members and their qualifications should be maintained.

, Answer:

True

Question:

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

Question:

- 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.

Question:

Only members who in the IRB/IEC review and discussion should vote/provide
their opinion and/or advise.
Answer:

participate

Question:

True or False: The investigator may provide information on any aspect of the trial and can
participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC.
Answer:

FALSE. The investigator may provide information on any aspect
of the trial, but should not participate in the deliberations of the IRB/IEC or in the vote/opinion
of the IRB/IEC.