ICH E6(R2) - Good Clinical Practice
An IRB/IEC should safeguard the _______, _______, and ________ of all trial subjects. Special attention should be paid to trials that may include __________ subjects. correct answersRights, safety, and well being. Vulnerable.
The IRB/IEC should obtain which documents? correct answersTrial 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 answersApproval/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 answersCV
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 answersonce per year
When would the IRB/IEC potentially request more information than is outlined in paragraph 4.8.10 be given to subjects? correct answersWhen, 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 answersDetermine 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 answersThe 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 answersamount, 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 answersWritten 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 answersqualifications 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 answersa) 5
b) 1, nonscientific
c) 1, independent
Which IRB/IEC members should vote/provide opinion on a trial-related matter? correct answersOnly 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 answersTrue
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 answers- written operating procedures
- meetings
- GCP , Regulatory requirements
When should an IRB/IEC make its decisions? correct answersAt 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 answersparticipate
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 answersFALSE. 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 answersTRUE
The IRB/IEC should establish, document in writing, and follow its procedures, 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 correct answers
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
