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SOCRA 2020 > 21 CFR Part 312 > Flashcards

21 CFR Part 312 Flashcards

(66 cards)

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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
What is 21 CFR 312 Subpart C 48
Dispute resolution
26
What is 21 CFR 312 Subpart D 50
General responsibilities of sponsors
27
What is 21 CFR 312 Subpart D 52
transfer of obligations to a contract research organization
28
What is 21 CFR 312 Subpart D 53
Selecting investigators and monitors
29
What is 21 CFR 312 Subpart D 54
Emergency research under 50.24 of this chapter
30
What is 21 CFR 312 Subpart D 55
Informing investigators
31
What is 21 CFR 312 Subpart D 56
Review of ongoing investigations
32
What is 21 CFR 312 Subpart D 57
Recordkeeping and record retention
33
What is 21 CFR 312 Subpart D 58
Inspection of sponsor's records and reports
34
What is 21 CFR 312 Subpart D 59
Disposition of unused supply of investigational drug
35
What is 21 CFR 312 Subpart D 60
genearl responsibilities of investigators
36
What is 21 CFR 312 Subpart D 61
control of the investigational drug
37
What is 21 CFR 312 Subpart D 62
investigator recordkeeping and record retention
38
What is 21 CFR 312 Subpart D 64
investigator reports
39
What is 21 CFR 312 Subpart D 66
assurance of IRB review
40
What is 21 CFR 312 Subpart D 68
Inspection of investigator's records and reports
41
What is 21 CFR 312 Subpart D 69
handling of controlled substances
42
What is 21 CFR 312 Subpart D 70
Disqualificatino of a clinical investigator
43
21 CFR 312 Subpart B
Investigational new Drug Application
44
21 CFR 312 Subpart C
Administrative Actions
45
21 CFR 312 Subpart D
Responsibilities of Sponsors and Investigators
46
21 CFR 312 Subpart E
Drugs Intended to treat life-threatening and severely debilitating illnesses
47
21 CFR 312 Subpart F
Miscellaneous
48
21 CFR 312 Subpart G
Drugs for investigational use in laborator research animals or invitro tests
49
21 CFR 312 Subpart I
Expanded access to investigational drugs for treatment use
50
21 CFR 312 Subpart E 82
Early consultation
51
21 CFR 312 Subpart E 83
Treatment protocols
52
21 CFR 312 Subpart E 84
Risk benefit analysis in review of marketing applications for drugs to treat life-threatning and severely-debilitating illnesses
53
21 CFR 312 Subpart E 85
Phase 4 studies
54
21 CFR 312 Subpart E 86
focused FDA regulatory research
55
21 CFR 312 Subpart E 87
Active monitoring of conduct and evaluation of clinical trials
56
21 CFR 312 Subpart E 88
Safeguards for patient safety
57
21 CFR 312 Subpart F 110
Import and export requirements
58
21 CFR 312 Subpart F 120
Foreign clinical studies not conducted under an IND
59
21 CFR 312 Subpart F 130
Availability for public disclosure of data and information in an IND
60
21 CFR 312 Subpart F 140
Address for correspondence
61
21 CFR 312 Subpart F 145
Guidance documents
62
21 CFR 312 Subpart G 160
Drugs for investigational use in laboratory research animals or in vitro tests
63
21 CFR 312 Subpart I 305
Requirements for all expanded access uses
64
21 CFR 312 Subpart I 310
Individual patients, including for emergency use
65
21 CFR 312 Subpart I 315
Intermediate size patient populations
66
21 CFR 312 Subpart I 3210
Treatment IND or treatment protocol

SOCRA 2020 (12 decks)

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