Quiz Results - Basic Institutional Review Board (IRB) Regulations and Review Process
You correctly answered 5 of 5 and received 5 of 5 possible points.

Scroll down to review the quiz questions and the explanation of the answers.
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 in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
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 : 1
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 :
Research investigators are responsible for retaining signed consent documents, IRB correspondence, and research records for at least three years after completion of the research. Since research records are property of the institution, local institutional policy or sponsoring agency requirements may dictate these records are kept longer. The sponsor and the IRB office should be contacted to make sure that the minimum of three years meets their requirements.
Points Earned : 1
Question 3
Question :
According to federal regulations, which of the following best describes