E6: IRB/IEC - Procedures Flashcards
The IRB/IEC should establish, document in writing, and follow its procedures, which should include:
IRB/IEC - Procedures
3.3.1
Determining its composition (names and qualifications of the members) and the authority under which it is established.
IRB/IEC - Procedures
3.3.2
Scheduling, notifying its members of, and conducting its meetings.
IRB/IEC - Procedures
3.3.3
Conducting initial and continuing review of trials.
IRB/IEC - Procedures
3.3.4
Determining the frequency of continuing review, as appropriate.
IRB/IEC - Procedures
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.
IRB/IEC - Procedures
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.
IRB/IEC - Procedures
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 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).
IRB/IEC - Procedures
3.3.8
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 (see 3.3.7, 4.5.2, 4.5.4).
(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.
IRB/IEC - Procedures
3.3.9
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.
