17 Questions
Who should provide opinion on a trial-related matter?
Members who are independent of the investigator and the sponsor
What should an IRB/IEC maintain according to the regulations?
A list of IRB/IEC members and their qualifications
When can an IRB/IEC make decisions?
During the scheduled announced meetings with a quorum present
Who is allowed to vote or provide opinion in an IRB/IEC meeting?
Members who participate in the review and discussion
What is the role of the investigator in an IRB/IEC meeting?
To provide information but not participate in deliberations or voting
What is the purpose of inviting nonmembers with expertise in special areas by an IRB/IEC?
To provide assistance and expertise in specific areas
What does an IRB/IEC need to determine according to the text in section 3.3.1?
Composition and qualifications of its members
When can an investigator initiate deviations or changes of a protocol without prior written IRB/IEC approval?
When necessary to eliminate immediate hazards to the subjects or for logistical/administrative aspects
What should an investigator promptly report to the IRB/IEC as per section 3.3.8?
Deviations or changes of the protocol to eliminate immediate hazards to the trial subjects
Under what circumstances can a subject be admitted to a trial according to section 3.3.6?
After written approval/favourable opinion from the IRB/IEC
What is an institution without its own IRB/IEC instructed to do according to the text in section 3.2.7?
Request IRB/IEC of Ministry of Health, Malaysia to make decisions on its behalf
What type of information should the IRB/IEC promptly notify the investigator/institution about?
Changes that may affect the safety of subjects
How long should the IRB/IEC retain relevant records after the completion of a trial?
3 years
What should the IRB/IEC provide upon request from regulatory authorities?
Membership lists and written procedures
Which of the following is NOT a function of the IRB/IEC?
Retaining records for 5 years after trial completion
What type of information should the IRB/IEC NOT promptly notify the investigator/institution about?
Membership lists and submitted documents
In what circumstances may the investigator/institution appeal against IRB/IEC decisions/opinions?
When disagreeing with IRB/IEC decisions/opinions
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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