Independent IRB/IEC Members Quiz
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Questions and Answers

Who should provide opinion on a trial-related matter?

  • The investigator and the sponsor
  • The research participants
  • Members who are independent of the investigator and the sponsor (correct)
  • Any member of the IRB/IEC

    • What should an IRB/IEC maintain according to the regulations?

  • A list of qualified researchers at the institution
  • The trial budget details
  • A list of IRB/IEC members and their qualifications (correct)
  • The sponsor's contact information

    • When can an IRB/IEC make decisions?

  • During the scheduled announced meetings with a quorum present (correct)
  • At any time convenient for the members
  • After hearing from all research participants
  • In private discussions with the investigator

    • Who is allowed to vote or provide opinion in an IRB/IEC meeting?

    <p>Members who participate in the review and discussion</p> Signup and view all the answers

    What is the role of the investigator in an IRB/IEC meeting?

    <p>To provide information but not participate in deliberations or voting</p> Signup and view all the answers

    What is the purpose of inviting nonmembers with expertise in special areas by an IRB/IEC?

    <p>To provide assistance and expertise in specific areas</p> Signup and view all the answers

    What does an IRB/IEC need to determine according to the text in section 3.3.1?

    <p>Composition and qualifications of its members</p> Signup and view all the answers

    When can an investigator initiate deviations or changes of a protocol without prior written IRB/IEC approval?

    <p>When necessary to eliminate immediate hazards to the subjects or for logistical/administrative aspects</p> Signup and view all the answers

    What should an investigator promptly report to the IRB/IEC as per section 3.3.8?

    <p>Deviations or changes of the protocol to eliminate immediate hazards to the trial subjects</p> Signup and view all the answers

    Under what circumstances can a subject be admitted to a trial according to section 3.3.6?

    <p>After written approval/favourable opinion from the IRB/IEC</p> Signup and view all the answers

    What is an institution without its own IRB/IEC instructed to do according to the text in section 3.2.7?

    <p>Request IRB/IEC of Ministry of Health, Malaysia to make decisions on its behalf</p> Signup and view all the answers

    What type of information should the IRB/IEC promptly notify the investigator/institution about?

    <p>Changes that may affect the safety of subjects</p> Signup and view all the answers

    How long should the IRB/IEC retain relevant records after the completion of a trial?

    <p>3 years</p> Signup and view all the answers

    What should the IRB/IEC provide upon request from regulatory authorities?

    <p>Membership lists and written procedures</p> Signup and view all the answers

    Which of the following is NOT a function of the IRB/IEC?

    <p>Retaining records for 5 years after trial completion</p> Signup and view all the answers

    What type of information should the IRB/IEC NOT promptly notify the investigator/institution about?

    <p>Membership lists and submitted documents</p> Signup and view all the answers

    In what circumstances may the investigator/institution appeal against IRB/IEC decisions/opinions?

    <p><code>When disagreeing with IRB/IEC decisions/opinions</code></p> Signup and view all the answers

    Study Notes

    IRB/IEC Composition and Function

    • IRB/IEC should have at least one independent member of the institutional/trial site.
    • Only independent members of the IRB/IEC should vote or provide an opinion on trial-related matters.

    IRB/IEC Procedures

    • IRB/IEC should follow written operating procedures.
    • Written records of activities and meeting minutes should be maintained.
    • IRB/IEC should comply with GCP and applicable regulatory requirements.

    Decision-Making Process

    • Decisions should be made at announced meetings with a quorum present.
    • Only participating members should vote or provide an opinion.
    • The investigator may provide information but should not participate in deliberations or voting.

    Additional Provisions

    • IRB/IEC may invite non-members with expertise for assistance.
    • Institutions without an IRB/IEC may request the Ministry of Health, Malaysia to make decisions on their behalf.

    IRB/IEC Written Procedures

    • Procedures should include determining composition and authority, scheduling and conducting meetings, and conducting initial and continuing reviews of trials.
    • Procedures should also specify the frequency of continuing review, expedited review, and approval of minor changes.

    Trial Conduct

    • No subject should be admitted to a trial before IRB/IEC approval.
    • No deviations or changes should be initiated without prior written IRB/IEC approval.
    • The investigator should promptly report deviations, changes, and adverse drug reactions to the IRB/IEC.

    IRB/IEC Notification and Records

    • IRB/IEC should notify the investigator/institution in writing of trial-related decisions, reasons, and appeal procedures.
    • IRB/IEC should retain records for at least 3 years after trial completion and make them available upon request from regulatory authorities.

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    Description

    Test your knowledge on the role of independent IRB/IEC members in clinical trials. Learn about the importance of having members who are unbiased from the investigator and sponsor of the trial, as well as the maintenance of records and compliance with GCP guidelines.

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