ICH-E6A IRB/IEC Flashcards
Clinical trials should be conducted in accordance with the ethical principles that have their origin in _______________ and that are consistent with _________
Declaration of Helsinki,
GCP and the applicable regulatory requirement(s).
True or False?
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
True
True or False?
Clinical trials should be scientifically sound, and described in a clear, detailed IC.
False-Protocol
True or False?
The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of the sponsor.
FALSE-qualified physician or, when appropriate, of a qualified dentist.
T/F?
Freely given informed consent should be obtained from every subject prior to clinical trial participation.
True
Investigational products should be manufactured, handled, and stored in accordance with applicable ___________. They should be used in accordance with the approved protocol.
good manufacturing practice (GMP)
True or False?
Systems with procedures that assure the quality of every aspect of the trial should be implemented.
True
What should an IRB do?
An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.
What 9 documents should be obtained by the IRB?
1. Trial Protocols/Ammendments
2. Written IC and updates that will be used in trial
3. Subject Recruitment Procedures (Ads)
4. Written Information to be provided to the subjects
5. IB
6. Available Safety Information
7. info about payments/or compensation to subjects
8. Investigators CV
9. any other documents IRB may need to fulfill its responisbilities.
What are 4 possible outcomes an IRB may have?
1. approval/favourable opinion
2. modifications required prior to its approval/favourable opinion
3.disapproval / negative opinion
4. termination/suspension of any prior approval/favourable opinion.
True or False?
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 every two years.
False-once a year
Can the IRB make the sponsor provide more information to the subjects?
Yes-The IRB/IEC may request more information than is outlined 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
When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable representative , the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses __________ and meets applicable regulatory requirements for such trials.
relevant ethical concerns
True or False?
The IRB/IEC should not review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects.
False
Payments made to subjects should be________. and not wholly contingent on _______of the______ by the subjects.
prorated
contingent
completion
Does information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects have to be set forth in the written informed consent form and any other written information to be provided to subjects?
Yes
True or False?
The way payment will be prorated does not have to be specified in the informed consent?
False
Define the characteristics of an IRB:
- *(a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.**
Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter.
Does an IRB roster have to be maintained?
Yes
True or False?
The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).
True
True or False:
An IRB/IEC should make its decisions at announced and emergency meetings at which at least a quorum, as stipulated in its written operating procedures, is present.
F. Emergency doesn’t belong.
True of False?
Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion and/or advise.
True
True or False?
An IRB/IEC may not invite nonmembers with expertise in special areas for assistance.
False
Which is not a procedure the IRB should establish and socument?
- 3.1 Determining its composition (names and qualifications of the members) and the authority under which it is established.
- 3.2 Scheduling, notifying its members of, and conducting its meetings.
- 3.3 Conducting initial and continuing review of trials.
- 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.
- 3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial.
- 3.7 Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate 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).
- 3.8 Specifying that the investigator should promptly report to the IRB/IEC:
(a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects
(b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2).
(c) All adverse drug reactions (ADRs) that are both serious and unexpected.
(d) New information that may affect adversely the safety of the subjects or the conduct of the trial. - 3.9 Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning:
(a) Its trial-related decisions/opinions.
(b) The reasons for its decisions/opinions.
(c) Procedures for appeal of its decisions/opinions.
They all are
How long does the IRB/IEC retain all relevant records (written procedures, membership lists, submitted documents, meeting minutes, correspondence)?
at least 3-years after completion of the trial and make them available upon request from the regulatory authority(ies).
What should the INVESTIGATOR promptly report to the IRB?
(a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4).
(b) Changes increasing the risk to subjects and/or affecting significantly the conduct ofthe trial (see 4.10.2).
(c) All adverse drug reactions (ADRs) that are both serious and unexpected.
(d) New information that may affect adversely the safety of the subjects or the conduct of the trial
