Podcast
Questions and Answers
Who should provide opinion on a trial-related matter?
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?
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?
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?
Who is allowed to vote or provide opinion in an IRB/IEC meeting?
What is the role of the investigator in an IRB/IEC meeting?
What is the role of the investigator in an IRB/IEC meeting?
What is the purpose of inviting nonmembers with expertise in special areas by an IRB/IEC?
What is the purpose of inviting nonmembers with expertise in special areas by an IRB/IEC?
What does an IRB/IEC need to determine according to the text in section 3.3.1?
What does an IRB/IEC need to determine according to the text in section 3.3.1?
When can an investigator initiate deviations or changes of a protocol without prior written IRB/IEC approval?
When can an investigator initiate deviations or changes of a protocol without prior written IRB/IEC approval?
What should an investigator promptly report to the IRB/IEC as per section 3.3.8?
What should an investigator promptly report to the IRB/IEC as per section 3.3.8?
Under what circumstances can a subject be admitted to a trial according to section 3.3.6?
Under what circumstances can a subject be admitted to a trial according to section 3.3.6?
What is an institution without its own IRB/IEC instructed to do according to the text in section 3.2.7?
What is an institution without its own IRB/IEC instructed to do according to the text in section 3.2.7?
What type of information should the IRB/IEC promptly notify the investigator/institution about?
What type of information should the IRB/IEC promptly notify the investigator/institution about?
How long should the IRB/IEC retain relevant records after the completion of a trial?
How long should the IRB/IEC retain relevant records after the completion of a trial?
What should the IRB/IEC provide upon request from regulatory authorities?
What should the IRB/IEC provide upon request from regulatory authorities?
Which of the following is NOT a function of the IRB/IEC?
Which of the following is NOT a function of the IRB/IEC?
What type of information should the IRB/IEC NOT promptly notify the investigator/institution about?
What type of information should the IRB/IEC NOT promptly notify the investigator/institution about?
In what circumstances may the investigator/institution appeal against IRB/IEC decisions/opinions?
In what circumstances may the investigator/institution appeal against IRB/IEC decisions/opinions?
Flashcards are hidden until you start studying
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
