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SOCRA 2020 > 21 CFR Part 312 > Flashcards

21 CFR Part 312 Flashcards

1
Q

What does 21 CFR Part 312 cover?

A

Investigational New Drug Application

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2
Q

clinical investigation of a drug product that is lawfully marketed in the US is exempt from the requirements of this part if all of the following applies:

A
  1. The investigation is not intended to be reported to the FDA as a well-controlled study in suppport of a new indicatino for use nor intended to be used to support any other significant change in the labeling of the drug. 2) If the drug that is undergoing investiagtion is lawfully marketed as a prescription drug product, the investigation is not intended to support a significnat change in the advertising for the product. 3) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks associated with the use of the drug product. 4) Investigation is conducted in compliance w/ the IRB and appropriately consents. 5) Investigation is conducted in compliance with the requirements.
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3
Q

What products are exempt from requirements of 312?

A

1) blood grouping serum 2) reagent red blood cells, and 3) anti-human globulin.

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4
Q

What type of drug is exempt from requirements of 312?

A

a drug intended solely for tests in vitro or in laboratory research animals.

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5
Q

A clinical investigation involving use of THIS is exempt from the requirements of 312 if the investigation does not otherwise require submission of an IND

A

Placebo.

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6
Q

Bioavailability studies

A

YES is subject to provisions of 320.31

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7
Q

Unlabeled indication

A

No, does not apply to the use in the practice of medicine for an unlabeled indication of a new drug product

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8
Q

Independent ethics committee (IEC)

A

a review panel that is responsibile for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately consititued to prvode assurance of that protection.

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9
Q

Investigational new drug

A

a new drug or biological drug that is used in a clinical investigation.

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10
Q

What is 21 CFR 312 Subpart B 20

A

Requirement for an IND

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11
Q

What is 21 CFR 312 Subpart B 21

A

Phases of an investigation

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12
Q

What is 21 CFR 312 Subpart B 22

A

General principles of the IND submission

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13
Q

What is 21 CFR 312 Subpart B 23

A

IND content and format

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14
Q

What is 21 CFR 312 Subpart B 30

A

Protocol amendments

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15
Q

What is 21 CFR 312 Subpart B 31

A

Information amendments

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16
Q

What is 21 CFR 312 Subpart B 32

A

IND safety reporting

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17
Q

What is 21 CFR 312 Subpart B 33

A

Annual Reports

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18
Q

What is 21 CFR 312 Subpart B 38

A

Withdrawal of an IND

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19
Q

What is 21 CFR 312 Subpart C 40

A

General requirements for use of an investigational new drug in a clinical investigation

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20
Q

What is 21 CFR 312 Subpart C 41

A

comment and advice on an IND

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21
Q

What is 21 CFR 312 Subpart C 42

A

Clinical holds and requests for modification

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22
Q

What is 21 CFR 312 Subpart C 44

A

Termination

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23
Q

What is 21 CFR 312 Subpart C 45

A

Inactive status

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24
Q

What is 21 CFR 312 Subpart C 47

A

Meetings

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25
Q

What is 21 CFR 312 Subpart C 48

A

Dispute resolution

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26
Q

What is 21 CFR 312 Subpart D 50

A

General responsibilities of sponsors

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27
Q

What is 21 CFR 312 Subpart D 52

A

transfer of obligations to a contract research organization

28
Q

What is 21 CFR 312 Subpart D 53

A

Selecting investigators and monitors

29
Q

What is 21 CFR 312 Subpart D 54

A

Emergency research under 50.24 of this chapter

30
Q

What is 21 CFR 312 Subpart D 55

A

Informing investigators

31
Q

What is 21 CFR 312 Subpart D 56

A

Review of ongoing investigations

32
Q

What is 21 CFR 312 Subpart D 57

A

Recordkeeping and record retention

33
Q

What is 21 CFR 312 Subpart D 58

A

Inspection of sponsor’s records and reports

34
Q

What is 21 CFR 312 Subpart D 59

A

Disposition of unused supply of investigational drug

35
Q

What is 21 CFR 312 Subpart D 60

A

genearl responsibilities of investigators

36
Q

What is 21 CFR 312 Subpart D 61

A

control of the investigational drug

37
Q

What is 21 CFR 312 Subpart D 62

A

investigator recordkeeping and record retention

38
Q

What is 21 CFR 312 Subpart D 64

A

investigator reports

39
Q

What is 21 CFR 312 Subpart D 66

A

assurance of IRB review

40
Q

What is 21 CFR 312 Subpart D 68

A

Inspection of investigator’s records and reports

41
Q

What is 21 CFR 312 Subpart D 69

A

handling of controlled substances

42
Q

What is 21 CFR 312 Subpart D 70

A

Disqualificatino of a clinical investigator

43
Q

21 CFR 312 Subpart B

A

Investigational new Drug Application

44
Q

21 CFR 312 Subpart C

A

Administrative Actions

45
Q

21 CFR 312 Subpart D

A

Responsibilities of Sponsors and Investigators

46
Q

21 CFR 312 Subpart E

A

Drugs Intended to treat life-threatening and severely debilitating illnesses

47
Q

21 CFR 312 Subpart F

A

Miscellaneous

48
Q

21 CFR 312 Subpart G

A

Drugs for investigational use in laborator research animals or invitro tests

49
Q

21 CFR 312 Subpart I

A

Expanded access to investigational drugs for treatment use

50
Q

21 CFR 312 Subpart E 82

A

Early consultation

51
Q

21 CFR 312 Subpart E 83

A

Treatment protocols

52
Q

21 CFR 312 Subpart E 84

A

Risk benefit analysis in review of marketing applications for drugs to treat life-threatning and severely-debilitating illnesses

53
Q

21 CFR 312 Subpart E 85

A

Phase 4 studies

54
Q

21 CFR 312 Subpart E 86

A

focused FDA regulatory research

55
Q

21 CFR 312 Subpart E 87

A

Active monitoring of conduct and evaluation of clinical trials

56
Q

21 CFR 312 Subpart E 88

A

Safeguards for patient safety

57
Q

21 CFR 312 Subpart F 110

A

Import and export requirements

58
Q

21 CFR 312 Subpart F 120

A

Foreign clinical studies not conducted under an IND

59
Q

21 CFR 312 Subpart F 130

A

Availability for public disclosure of data and information in an IND

60
Q

21 CFR 312 Subpart F 140

A

Address for correspondence

61
Q

21 CFR 312 Subpart F 145

A

Guidance documents

62
Q

21 CFR 312 Subpart G 160

A

Drugs for investigational use in laboratory research animals or in vitro tests

63
Q

21 CFR 312 Subpart I 305

A

Requirements for all expanded access uses

64
Q

21 CFR 312 Subpart I 310

A

Individual patients, including for emergency use

65
Q

21 CFR 312 Subpart I 315

A

Intermediate size patient populations

66
Q

21 CFR 312 Subpart I 3210

A

Treatment IND or treatment protocol

SOCRA 2020 (12 decks)

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