FDA regulations

Question 1

21 CFR 56.109(f)

Answer 1

Conducting continuing review of research at least once per year

Question 2

21 CFR 56.109(c)

Answer 2

determine when and at what level of informed consent is required or waived

Question 3

21 CFR 50.24

Answer 3

exception from informed consent requirements for emergency research

Question 4

21 CFR 812.110(c)

Answer 4

requires that an investigator administer the investigational product or supervise appropriate staff who will be administering for medical device trials

Question 5

21 CFR 56.115 (c)

Answer 5

FDA may refuse to consider a clinical investigation if the institution or IRB that reviewed the investigation refuses to allow an inspection

Question 6

21 CFR 56.115 (b)

Answer 6

requires that IRB records be retained for at least 3 years after completion of the research

Question 7

21 CFR 56.113

Answer 7

terminate any research that is not being conducted following regulations or research that caused unexpected serious harm to subjects

Question 8

21 CFR 56.111(a)

Answer 8

requires criteria that an IRB must find when approving a study

• minimal risk
• documented consent
• selection of subjects is equitable
• monitor data
• privacy detected
• protect women, prisoners, children

Question 9

21 CFR 312.32

Answer 9

requires that the sponsor then must notify FDA and all participating investigations of potential serious risks asap or no later than 15 calendar days

Question 10

21 CFR 312.60

Answer 10

describes responsibilities of investigators

• oversee conduct of the trial under appropriate regulation
• protect the rights, safety and welfare of subjects
• control the use of investigational products

Question 11

21 CFR 56.109

Answer 11

describes an approach for IRB review of research

-continuing review and re-approval of a research study

Question 12

21 CFR 56.109(a)

Answer 12

review, approve, or disapprove all research activities under jurisdiction based on benefits and evaluation

Question 13

21 CFR 56.109(b)

Answer 13

oversee informed consent process and all documents to be used and presented to subjects

Question 14

21 CFR 56.115

Answer 14

requires IRB to prepare and maintain documentation of IRB activities

• copies of all research proposals
• minutes of IRB meeting
• records of continuing review
• copies of all correspondences
• list of IRB members
• written procedures

Question 15

45 CFR 46.409

Answer 15

when research involves greater than minimal risk with no direct benefit to subjects, the research must either be related to the children’s status as words or be conducted in the setting where the majority of children are not involved in words

Question 16

21 CFR 809.3(a)

Answer 16

defines IVDs invitro diagnostics away to test for certain property or result outside of the human body. EX. testing blood, urine, glucose

Question 17

45 CFR 46.116(a)

Answer 17

IRB determines that the requirements for obtaining informed consent may be waived.

• research involves no more than minimal risk
• waiter or alteration will not adverse effect subjects
• subjects will be provided additional info as appropriate

Question 18

45 CFR 46.406

Answer 18

For children: The intervention or procedure is likely to yield generalizable knowledge for the understanding or treatment of the subjects disorders or conditions

Question 19

45 CFR 46.407

Answer 19

For Children: research that is not otherwise approvable but presents opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
-also be done with sound ethics

Question 20

45 CFR 46.405

Answer 20

For children: the relationship of risk to benefit is at least favorable as any available alternative approach