Informed Consent - Module 4s Sec 5


Module 4 Objectives
Continuing Review
Unanticipated Developments
Adverse Events
Consent Document Revisions


heck your knowledge of the after approval requirements. Click on the correct answer to each question.

When you are finished, the Next button will take you to Test Your Understanding, or the Menu button will take you to the menu screen.

Question 1 of 5

Once a project has been initially reviewed and approved by the IRB, no further review is necessary.

True False

Question 2 of 5

The death of a study subject should be reported to the IRB if it is believed to be unrelated to the study.

True False

Question 3 of 5

Unexpected problems whose nature, severity, or frequency are not described in the information provided to the IRB or to participants are called:

Aadverse events

Bbad luck

Cside effects


Question 4 of 5

Continuing review of a study by the IRB occurs at least:





Question 5 of 5

The terms of a continuing review are outlined when original approval is granted.

True False

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