ICH E6(R2) - Good Clinical Practice
Questions with 100% Correct Answers
An IRB/IEC should safeguard the _______, _______, and ________ of all trial
subjects. Special attention should be paid to trials that may include __________
subjects. Correct Answer: Rights, safety, and well being. Vulnerable.
The IRB/IEC should obtain which documents? Correct 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 Correct 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. Correct 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 _____________.
Correct 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? Correct 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? Correct 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)? Correct 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. Correct 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? Correct
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. Correct 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.
Correct Answer: a) 5
b) 1, nonscientific
c) 1, independent
Which IRB/IEC members should vote/provide opinion on a trial-related matter?
Correct 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. Correct 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
______________________________. Correct Answer: - written operating procedures
- meetings
, - GCP, Regulatory requirements
When should an IRB/IEC make its decisions? Correct Answer: At announced
meetings at which at least a quorum, as stipulated in its written operating
procedures, is present.
Only members who ______________ in the IRB/IEC review and discussion should
vote/provide their opinion and/or advise. Correct Answer: participate
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. Correct 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.
True or False: IRB/IEC may invite nonmembers with expertise in special areas for
assistance. Correct Answer: TRUE
The IRB/IEC should retain all relevant records (e.g., written procedures,
membership lists, lists of occupations/affiliations of members, submitted
documents, minutes of meetings, and correspondence) for a period of at least
___________ years after completion of the trial and make them available upon
request from the regulatory authority(ies). Correct Answer: 3
True or False: The IRB/IEC may be asked by investigators, sponsors or regulatory
authorities to provide its written procedures and membership lists. Correct
Answer: True
The investigator(s) should be qualified by _________ , __________, and ___________
to assume responsibility for the proper conduct of the trial, should meet all the
_____________ specified by the applicable regulatory requirement(s), and should
provide evidence of such qualifications through up-to-date ______________
Questions with 100% Correct Answers
An IRB/IEC should safeguard the _______, _______, and ________ of all trial
subjects. Special attention should be paid to trials that may include __________
subjects. Correct Answer: Rights, safety, and well being. Vulnerable.
The IRB/IEC should obtain which documents? Correct 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 Correct 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. Correct 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 _____________.
Correct 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? Correct 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? Correct 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)? Correct 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. Correct 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? Correct
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. Correct 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.
Correct Answer: a) 5
b) 1, nonscientific
c) 1, independent
Which IRB/IEC members should vote/provide opinion on a trial-related matter?
Correct 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. Correct 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
______________________________. Correct Answer: - written operating procedures
- meetings
, - GCP, Regulatory requirements
When should an IRB/IEC make its decisions? Correct Answer: At announced
meetings at which at least a quorum, as stipulated in its written operating
procedures, is present.
Only members who ______________ in the IRB/IEC review and discussion should
vote/provide their opinion and/or advise. Correct Answer: participate
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. Correct 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.
True or False: IRB/IEC may invite nonmembers with expertise in special areas for
assistance. Correct Answer: TRUE
The IRB/IEC should retain all relevant records (e.g., written procedures,
membership lists, lists of occupations/affiliations of members, submitted
documents, minutes of meetings, and correspondence) for a period of at least
___________ years after completion of the trial and make them available upon
request from the regulatory authority(ies). Correct Answer: 3
True or False: The IRB/IEC may be asked by investigators, sponsors or regulatory
authorities to provide its written procedures and membership lists. Correct
Answer: True
The investigator(s) should be qualified by _________ , __________, and ___________
to assume responsibility for the proper conduct of the trial, should meet all the
_____________ specified by the applicable regulatory requirement(s), and should
provide evidence of such qualifications through up-to-date ______________
