ICH E6(R2) - GOOD CLINICAL PRACTICE 2025|\
COMPLETE SOLUTION RATED 5 STARS>> 270 Q &
A.
1. An IRB/IEC should safeguard the , , and of all
trial subjects. Special attention should be paid to trials that may include
subjects.: Rights, safety, and well being. Vulnerable.
2. The IRB/IEC should obtain which documents?: Trial protocol(s)/amend-
ment(s). Written informed consent form(s) and consent form updates that the in-
vestigator proposes for use in the trial, Subject recruitment procedures (e.g., adver-
tisements), 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 docu-
mentation evidencing qualifications, and any other documents that the IRB/IEC may
need to fulfil its responsibilities
3. 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: Approval/favourable opinion; modifica-
tions required prior to its approval/favourable opinion; disapproval / negative opinion;
and termination/suspension of any prior approval/favourable opinion.
4. 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.: CV
5. 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
.: once per year
6. When would the IRB/IEC potentially request more information than is out-
lined in paragraph 4.8.10 be given to subjects?: 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.
7. 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?: Determine that the proposed protocol and/or other document(s)
adequately addresses relevant ethical concerns and meets applicable regulatory
requirements for such trials.
8. What should the IRB/IEC do when the protocol indicates that prior con-
sent of the trial subject or the subject's legally acceptable representative
is not possible (see 4.8.15)?: 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).
9. The IRB/IEC should review both the and of pay-
ment 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.: amount, method. coercion, undue influence. prorated, not.
10. The IRB/IEC should ensure that information regarding payment to sub-
jects, including the methods, amounts, schedule of payment to trial subjects,
and the way payment will be prorated should be set forth in what document?-
: Written Informed Consent Form and any other written information to be provided
to subjects.
11. The IRB/IEC should consist of a reasonable number of members, who col-
lectively have the and to review and evaluate
the science, medical aspects, and ethics of the proposed trial.: qualifications
and experience
12. 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.: a) 5
b) 1, nonscientific
c) 1, independent
13. Which IRB/IEC members should vote/provide opinion on a trial-related
matter?: Only those members who are independent of the investigator and the
sponsor of the trial
14. True or False: A list of IRB/IEC members and their qualifications should be
maintained.: True
15. 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
.: - written operating procedures
- meetings
- GCP, Regulatory requirements
16. When should an IRB/IEC make its decisions?: At announced meetings at
which at least a quorum, as stipulated in its written operating procedures, is present.
17. Only members who in the IRB/IEC review and discussion
should vote/provide their opinion and/or advise.: participate
18. 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.: 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.
19. True or False: IRB/IEC may invite nonmembers with expertise in special
areas for assistance.: TRUE
20. The IRB/IEC should establish, document in writing, and follow its proce-
dures, which should include:
3.3.1 Determining its composition (names and qualifications of the members)
and the authority under which it is established. 3.3.2 Scheduling, notifying
its members of, and conducting its meetings. 3.3.3 Conducting initial and
continuing review of trials. 3.3.4 Determining the frequency of continuing
review, as appropriate.3.3.5 Providing, according to the applicable regulatory
requirements, expedited review and approval/favourable opinion of minor
change(s) in ongoing trials that have the approval/favourable opinion of the
IRB/IEC. 3.3.6 Specifying that no subject should be admitted to a trial before
the IRB/IEC issues its written approval/favourable opinion of the trial. 3.3.7
Specifying that no deviations from, or changes of, the protocol should be
initiated without prior written IRB/IEC approval/favourable opinion of an ap-
propriate amendment, except when necessary to eliminate immediate hazards
to the subjects or when the change(s) involves only logistical or administrative
aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see
4.5.2). 3.3.8 Specifying that the inv:
21. The IRB/IEC should retain all relevant records (e.g., written procedures,
membership lists, lists of occupations/affiliations of members, submitted doc-
uments, 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).: 3
22. True or False: The IRB/IEC may be asked by investigators, sponsors or
regulatory authorities to provide its written procedures and membership lists.-
: True
23. 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 and/or other relevant documentation requested
by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).: education,
training, and experience.
qualifications
curriculum vitae
COMPLETE SOLUTION RATED 5 STARS>> 270 Q &
A.
1. An IRB/IEC should safeguard the , , and of all
trial subjects. Special attention should be paid to trials that may include
subjects.: Rights, safety, and well being. Vulnerable.
2. The IRB/IEC should obtain which documents?: Trial protocol(s)/amend-
ment(s). Written informed consent form(s) and consent form updates that the in-
vestigator proposes for use in the trial, Subject recruitment procedures (e.g., adver-
tisements), 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 docu-
mentation evidencing qualifications, and any other documents that the IRB/IEC may
need to fulfil its responsibilities
3. 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: Approval/favourable opinion; modifica-
tions required prior to its approval/favourable opinion; disapproval / negative opinion;
and termination/suspension of any prior approval/favourable opinion.
4. 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.: CV
5. 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
.: once per year
6. When would the IRB/IEC potentially request more information than is out-
lined in paragraph 4.8.10 be given to subjects?: 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.
7. 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?: Determine that the proposed protocol and/or other document(s)
adequately addresses relevant ethical concerns and meets applicable regulatory
requirements for such trials.
8. What should the IRB/IEC do when the protocol indicates that prior con-
sent of the trial subject or the subject's legally acceptable representative
is not possible (see 4.8.15)?: 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).
9. The IRB/IEC should review both the and of pay-
ment 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.: amount, method. coercion, undue influence. prorated, not.
10. The IRB/IEC should ensure that information regarding payment to sub-
jects, including the methods, amounts, schedule of payment to trial subjects,
and the way payment will be prorated should be set forth in what document?-
: Written Informed Consent Form and any other written information to be provided
to subjects.
11. The IRB/IEC should consist of a reasonable number of members, who col-
lectively have the and to review and evaluate
the science, medical aspects, and ethics of the proposed trial.: qualifications
and experience
12. 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.: a) 5
b) 1, nonscientific
c) 1, independent
13. Which IRB/IEC members should vote/provide opinion on a trial-related
matter?: Only those members who are independent of the investigator and the
sponsor of the trial
14. True or False: A list of IRB/IEC members and their qualifications should be
maintained.: True
15. 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
.: - written operating procedures
- meetings
- GCP, Regulatory requirements
16. When should an IRB/IEC make its decisions?: At announced meetings at
which at least a quorum, as stipulated in its written operating procedures, is present.
17. Only members who in the IRB/IEC review and discussion
should vote/provide their opinion and/or advise.: participate
18. 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.: 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.
19. True or False: IRB/IEC may invite nonmembers with expertise in special
areas for assistance.: TRUE
20. The IRB/IEC should establish, document in writing, and follow its proce-
dures, which should include:
3.3.1 Determining its composition (names and qualifications of the members)
and the authority under which it is established. 3.3.2 Scheduling, notifying
its members of, and conducting its meetings. 3.3.3 Conducting initial and
continuing review of trials. 3.3.4 Determining the frequency of continuing
review, as appropriate.3.3.5 Providing, according to the applicable regulatory
requirements, expedited review and approval/favourable opinion of minor
change(s) in ongoing trials that have the approval/favourable opinion of the
IRB/IEC. 3.3.6 Specifying that no subject should be admitted to a trial before
the IRB/IEC issues its written approval/favourable opinion of the trial. 3.3.7
Specifying that no deviations from, or changes of, the protocol should be
initiated without prior written IRB/IEC approval/favourable opinion of an ap-
propriate amendment, except when necessary to eliminate immediate hazards
to the subjects or when the change(s) involves only logistical or administrative
aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see
4.5.2). 3.3.8 Specifying that the inv:
21. The IRB/IEC should retain all relevant records (e.g., written procedures,
membership lists, lists of occupations/affiliations of members, submitted doc-
uments, 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).: 3
22. True or False: The IRB/IEC may be asked by investigators, sponsors or
regulatory authorities to provide its written procedures and membership lists.-
: True
23. 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 and/or other relevant documentation requested
by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).: education,
training, and experience.
qualifications
curriculum vitae
