Research Turn Around Times - IRB Flashcards
21 CFR 56 (IRB): Exemption from IRB requirement - Emergency use of a test article, provided that such emergency use is reported to the IRB within (blank). Any subsequent use of the test article at the institution is subject to IRB review.
5 days to report emergency use to IRB
21 CFR 56 (IRB): When must an IRB register? Each IRB must submit an initial registration. The initial registration must occur before the IRB begins to review a clinical investigation. Each IRB must renew its registration every (blank) . IRB registration becomes effective after review and acceptance by HHS.
3 years
21 CFR 56 (IRB): 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 (blank) of the change
90 days
21 CFR 56 (IRB): An IRB’s decision to disband is a change that must be reported within (blank) of permanent cessation of the IRB’s review of research
30 days
21 CFR 56 (IRB): An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than (blank), and shall have authority to observe or have a third party observe the consent process and the research.
once per year
21 CFR 56 (IRB): An IRB may use the expedited review procedure to review either or both of the following: (1) Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk, (2) minor changes in previously approved research during the period (blank) for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the IRB chairperson from among the members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited review procedure.
1 year
21 CFR 56 (IRB): The records required by this regulation shall be retained for at least (blank) 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.
3 years
