Part 56 - Institutional Review Boads

Question 1

Emergency use of a test article, provided that such emergency use is reported to the IRB within ___ _____ days. Any subsequent use of the test article at the institution is subject to IRB review.

Answer 1

5 working

Question 2

Each IRB must renew its registration every ___ years. IRB registration becomes effective after review and acceptance by HHS.

Answer 2

3

Question 3

If an IRB’s contact or chair person information changes, the IRB must revise its registration information by submitting any changes in that information within ___ days of the change.

Answer 3

90

Question 4

An IRB’s decision to review new types of FDA-regulated products (such as a decision to review studies pertaining to food additives whereas the IRB previously reviewed studies pertaining to drug products), or to discontinue reviewing clinical investigations regulated by FDA is a change that must be reported within ___ days of the change.

Answer 4

30

Question 5

An IRB’s decision to disband is a change that must be reported within ___ days of permanent cessation of the IRB’s review of research. All other information changes may be reported when the IRB renews its registration.

Answer 5

30

Question 6

The records required by this regulation shall be retained for at least ___ years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner

Answer 6

3