21 CFR

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 devise 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 reviewed 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 product

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 its jurisdiction based on benefits and risks 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

21 CFR 809.3 (a)

Answer 15

Defines IVDs in vitro diagnostics away to test for certain property or result outside of the human body. EX. Testing blood, urine, glucose

Question 16

21 CFR 312.62 (c)

Answer 16

Describes record retention for an investigator

• 2 years after FDA approval or
• 2 years after study ended

Question 17

21 CFR 312.69

Answer 17

Controlled substance act requires that investigational product be kept in secure location with control access

Question 18

21 CFR 312.64

Answer 18

Requires that an investigator immediately reports to the sponsor any SAE

• whether or not drug related
• include assessment of reasonable possibility that drug caused event

Question 19

21 CFR 312.61

Answer 19

Describes the responsibilities of an investigator for investigational product use and access in drug trials

Question 20

21 CFR 312.62 (a)

Answer 20

Requires investigators to maintain adequate records of disposition of the drug including dates, quantity and use by subjects.
-shall return unused supplies to the sponsor or provide disposition of unused supplies

Question 21

21 CFR 312.52 (c) (3)

Answer 21

Lists items a clinical protocol should contain
-phase 1 general outline of the planned investigation estimated duration and # of control, kind of clinical observations, lab tests performed and copies descriptions of CRFs

Question 22

21 CFR 812.150

Answer 22

Requires an investigator submits to sponsor and IRB a report of any UADE ASAP but no later than 10 working days after learning effect
- sponsor report to FDA and IRB within 10 working days

Question 23

21 CFR 812.3(m)

Answer 23

Defines significant risk (SR) device as a investigational device that is

• intended as a implant represented to be of use for supporting or sustaining human life
• used for diagnosing, curing, mitigating, or treating disease
• otherwise prevents risk

Question 24

21 CFR 812.2(c)

Answer 24

Defines an IDE exempt study

Question 25

21 CFR 312.3

Answer 25

Defines term investigator as individual who actually conducts a clinical investigation
-responsible leader of the team

Question 26

21 CFR 812.3

Answer 26

Unanticipated adverse device effect (UADE)
-any serious adverse event associated with a device that was not previously identified or UAP that relates to the rights, safety, or welfare of subjects

Question 27

21 CFR 50.25

Answer 27

Lists the basic elements of informed consent

Question 28

21 CFR 50.27

Answer 28

Documentation of informed consent is required

Question 29

21 CFR 50.27 (b)

Answer 29

Allow the use of a short form consent document

-also in 45 CFR 46.117 (b)

Question 30

21 CFR 56.102 (I)

Answer 30

Definition of minimal risk
-probability and magnitude of harm or discomfort is not greater than those encountered ordinarily in daily life or during routine physical exams or tests

Question 31

21 CFR 56.101

Answer 31

Maintain IRB compliance in term of its policies and standard practice with the requirements of all relevant regulatory agencies

Question 32

21 CFR 56.107

Answer 32

Summarizes criteria for IRB membership

• 5+ members
• diversity
• knowledgeable persons
• both men and women
• at least 1 scientific
• at least 1 non scientific
• at least 1 not affiliated with institution

Question 33

21 CFR 54.4 (b)

Answer 33

The regulation that requires investigators to provide information on financial interests and arrangements during the course of the study and 1 year after completion of the study

Question 34

21 CFR 54.4 (a)

Answer 34

If there are financial interests involved, steps taken to minimize the potential for bias should be given to the FDA

Question 35

21 CFR 54

Answer 35

Describes financial disclosure required by clinical investigators

Question 36

21 CFR 56.108 (C)

Answer 36

Disapproval of a research can only be done with the non expedited review procedure

Question 37

21 CFR 56.108 (a)

Answer 37

Requires IRB to follow written procedures

Question 38

21 CFR 56.102 (g)

Answer 38

Defines IRB

-assure protection of human subjects (rights and welfare)

Question 39

21 CFR 11.30

Answer 39

Describes regulations regarding electronic records and electronic signatures for an open system
-access not controlled

Question 40

21 CFR 11.10

Answer 40

Describes regulations regarding electronic signatures and records for a closed system
-access is controlled by persons who oversee content

Question 41

21 CFR 50.20

Answer 41

No person can participate in clinical research without the person or the person’s legally authorized representative (LAR)
-general requirements for informed consent