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Citi Training Exam Results Essay

611 words - 3 pages

Question 1
Question : A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Your answer : Report the adverse drug experience as part of the continuing review report.
Correct Answer : Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
Comment : The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution.
Points Earned : 0
Question 2
Question : How long is an investigator required to keep consent documents, IRB correspondence, and research records?
Your answer : For a minimum of three years after completion of the study
Correct Answer : For a minimum of three years after completion of the study
Comment : ...view middle of the document...

Expedited review procedures are appropriate only for protocols that present no greater than "minimal risk" to subjects and involve only procedures included in federally specified categories. Population considerations, such as healthy volunteers, are only relevant insofar as they affect the assessment of risk. The IRB may not conduct an expedited review for the convenience of either the IRB or a student researcher, if the protocol is otherwise not eligible.
Points Earned : 0
Question 4
Question : Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
Your answer : The changes must be immediately implemented for the health and well being of the subject.
Correct Answer : The changes must be immediately implemented for the health and well being of the subject.
Comment : All amendments involving changes to IRB approved protocols must be reviewed and approved in advance of implementation, unless changes must be put in place immediately to respond to an unexpected risk or problem arising during the course of a study.
Points Earned : 1
Question 5
Question : IRB continuing review of an approved protocol must:
Your answer : Be conducted by a convened IRB.
Correct Answer : Occur at least annually.
Comment : Approved protocols must be reviewed at least annually, although IRBs may specify a shorter review period. The expedited review procedure may be used for continuing review in a variety of circumstances, broadly speaking, those in which minimal risk remains minimal or when all activities involving more than minimal risk have been completed. It is the responsibility of the principal investigator to hold signed consent forms in confidentiality. Copies of these forms are not required by federal regulation to be reviewed by the IRB. Please note, however, that an institution's local policy may require copies of signed consent forms as part of the IRB continuing review process.
Points Earned : 0

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