Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

SOCRA Questions > Code of Federal Regulations > Flashcards

Code of Federal Regulations Flashcards

1
Q

Title 21

A

Food and Drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

21 CFR 11

A

Electronic Records, Electronic Signatures

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

21 CFR 11 Subpart A ______
11.1_______

A

Subpart A - General Provisions
11.1 - Scope

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

21 CFR 11 Subpart A ______
11.2_______

A

Subpart A - General Provisions
11.2 - Implementation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

21 CFR 11 Subpart A ______
11.3_______

A

Subpart A - General Provisions
11.3 - Definitions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

21 CFR 11 Subpart B

A

Electronic Records

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

21 CFR 11 Subpart B_______ 11.10____

A

Subpart B—Electronic Records
11.10 Controls for closed systems.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

21 CFR 11 Subpart C

A

Electronic Signatures

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

21 CFR 11 Subpart B ______
11.30_______

A

Subpart B - Electronic Records
11.30 - Controls for closed systems

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

21 CFR 11 Subpart C ______
11.100_______

A

Subpart C - Electronic Signatures
11.100 - General requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

21 CFR 11 Subpart C____
11.200______

A

Sub part C Electronic signatures
11.200 - Electronic signature components and controls

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

21 CFR 11 Subpart C _______
11.300_________

A

21 CFR 11 Subpart C Electronic Signatures
11.300 - Controls for identification codes/passwords

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

21 CFR 50

A

Part 50 - Protection of Human Subjects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

21 CFR 50 Subpart A

A

General Provisions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

21 CFR 50 Subpart A General Provisions
50.1

A

21 CFR 50 Subpart A General Provisions
50.1 - Scope

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

21 CFR 50 - Protection of Human Subjects
Subpart A General Provisions
50.3 - ?

A

21 CFR 50 Subpart A General Provisions
50.3 - Definitions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

21 CFR 50 Subpart B

A

Informed Consent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

21 CFR 50 Subpart B Informed Consent
50.20

A

50.20 - General requirements for informed consent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

21 CFR 50 Subpart B Informed Consent
50.23

A

50.23 - Exception for general requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

21 CFR 50 Subpart B ______
50.24______

A

50.24 - Exception from informed consent requirements for emergency research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

21 CFR 50 Subpart B Informed Consent
50.25

A

50.25 - Elements of informed consent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

21 CFR 50 Subpart B Informed Consent
50.27

A

50.27 - Documentation of informed consent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations
50.50

A

50.50 - IRB Duties

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations
50.51

A

50.51 - Clinical investigations not involving greater than minimal risk

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations
50.52

A

50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations
50.53

A

50.53 - Clinical investigations involving greater than minimal risk and no prospect to direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder of condition

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations
50.54

A

50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations
50.55

A

50.55 - Requirements for permission by parents or guardians and for assent by children

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations
50.56

A

50.56 - Wards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

Title 21 Part 56

A

Institutional Review Boards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

Title 21 Part 56 - Institutional Review Boards
Subpart A

A

Subpart A - General Provisions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

Title 21 Part 56 - Institutional Review Board
Subpart A - General Provisions
56.101

A

56.101 - Scope

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

Title 21 Part 56 - Institutional Review Board
Subpart A - General Provisions
56.102

A

56.102 - Definitions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

Title 21 Part 56 - Institutional Review Board
Subpart A - General Provisions
56.103

A

56.103 - Circumstances in which IRB review is required

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

Title 21 Part 56 - Institutional Review Board
Subpart A - General Provisions
56.104

A

56.104 - Exemptions from IRB requirement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

Title 21 Part 56_____
Subpart A______
56.105

A

56.105 - Waiver of IRB requirement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

Title 21 Part 56 - Institutional Review Board
Subpart B - ?

A

Subpart B - Organization and Personnel

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

Title 21 Part 56 -
Subpart B -
56.106 - ?

A

Part 56 Institutional Review Board
Sub part B Organization and Personnel
56.106 - Registration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

Title 21 Part 56 - _______
Subpart B_______
56.107 - ?

A

Part 56 - IRBs

Subpart B - Organization and Personnel
56.107 - IRB Membership

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

Title 21 Part 56 - Institutional Review Board
Subpart C

A

Subpart C - IRB Functions and Operations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

Title 21 Part 56 - Institutional Review Board
Subpart C - - IRB Functions and Operations
56.108

A

56.108 - IRB functions and operations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
42
Q

Title 21 Part 56 - Institutional Review Board
Subpart C - - IRB Functions and Operations
56.109

A

56.109 - IRB review of research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
43
Q

Title 21 Part 56 - Institutional Review Board
Subpart C - - IRB Functions and Operations
56.110

A

56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
44
Q

Title 21 Part 56 - Institutional Review Board
Subpart C - - IRB Functions and Operations
56.111

A

56.111 - Criteria for IRB approval of research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
45
Q

Title 21 Part 56 - Institutional Review Board
Subpart C - - IRB Functions and Operations
56.112

A

56.112 - Review by institution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
46
Q

Title 21 Part 56 - Institutional Review Board
Subpart C - - IRB Functions and Operations
56.113

A

56.113 - Suspension or termination of IRB approval of research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
47
Q

Title 21 Part 56 - Institutional Review Board
Subpart C - - IRB Functions and Operations
56.114

A

56.114 - Cooperative research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
48
Q

Title 21 Part 56 - Institutional Review Board
Subpart D

A

Subpart D - Records and Reports

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
49
Q

Title 21 Part 56 - Institutional Review Board
Subpart D
56.115

A

56.115 - IRB records

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
50
Q

Title 21 Part 56 - Institutional Review Board
Subpart E

A

Subpart E - Administrative Actions for Noncompliance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
51
Q

Title 21 Part 56 - Institutional Review Board
Subpart E - Administrative Actions for Noncompliance
56.120

A

56.120 - Lesser administrative actions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
52
Q

Title 21 Part 56 - Institutional Review Board
Subpart E - Administrative Actions for Noncompliance
56.121

A

56.121 -Disqualification of an IRB or an institution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
53
Q

Title 21 Part 56 - Institutional Review Board
Subpart E - Administrative Actions for Noncompliance
56.122

A

56.122 - Public disclosure of information regarding revocation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
54
Q

Title 21 Part 56 - Institutional Review Board
Subpart E - Administrative Actions for Noncompliance
56.123

A

56.123 - Reinstatement of an IRB or an institution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
55
Q

Title 21 Part 56 - Institutional Review Board
Subpart E - Administrative Actions for Noncompliance
56.124

A

56.124 - Actions alternative or additional to disqualification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
56
Q

Title 21 Part 312

A

Part 312 - Investigational New Drug Application

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
57
Q

Title 21 Part 312 - Investigational New Drug Application Subpart A

A

Subpart A - General Provisions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
58
Q

Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions
312.1

A

312.1 - Scope

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
59
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart A - General Provisions
312.2

A

312.2 - Applicability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
60
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart A - General Provisions
312.3

A

312.3 - Definitions and interpretations

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
61
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart A - General Provisions
312.6

A

312.6- Labeling of an investigational new drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
62
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart A - General Provisions
312.7

A

312.7 - Promotion of investigational drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
63
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart A - General Provisions
312.8

A

312.8 - Charging for investigational drugs under an IND

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
64
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart A - General Provisions
312.10

A

312.10 - Waivers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
65
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B

A

Subpart B - Investigational New Drug Application (IND)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
66
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.20

A

312.20 - Requirement of an IND

67
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.21 - Phases of an investigation

A

312.21 - Phases of an investigation

68
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.22

A

312.22 - General principles of the IND submission

69
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.23

A

312.23 - IND content and format

70
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.30

A

312.30 - Protocol amendments

71
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.31 - Information amendments

A

312.31 - Information amendments

72
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.32

A

312.32 - IND Safety Reporting

73
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.33 - Annual Reports

A

312.33 - Annual Reports

74
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B - Investigational New Drug Application (IND)
312.38

A

312.38 - Withdrawal of an IND

75
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C

A

Subpart C - Administrative Actions

76
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C - Administrative Actions
312.40

A

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

77
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C - Administrative Actions
312.41

A

312.41 - Comment and advice on an IND

78
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C - Administrative Actions
312.42

A

312.42 - Clinical holds and requests for modification

79
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C - Administrative Actions
312.44

A

312.44 - Termination

80
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C - Administrative Actions
312.45

A

312.45 - Inactive status

81
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C - Administrative Actions
312.47

A

312.47 - Meetings

82
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart C - Administrative Actions
312.48

A

312.48 - Dispute resolution

83
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D

A

Subpart D - Responsibilities of Sponsors and Investigators

84
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.50

A

312.50 - General responsibilities of sponsors

85
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.52

A

312.52 - Transfer of obligations to a contract research organization

86
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.53

A

312.53 - Selecting investigators and monitors

87
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.54

A

312.54 - Emergency research under §50.24 of this chapter

88
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.55

A

312.55 - Informing investigators

89
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.56

A

312.56 - Review of ongoing investigations

90
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.57

A

312.57 - Recordkeeping and record retention

91
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.58

A

312.58 - Inspection of sponsor’s records and reports

92
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.59

A

312.59 - Disposition of unused supply of investigational drug

93
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.60

A

312.60 - General responsibilities of investigators

94
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.61

A

312.61 - Control of the investigational drug

95
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.62

A

312.62 - Investigator recordkeeping and record retention

96
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.64

A

312.64 - Investigator reports

97
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.66

A

312.66 - Assurance of IRB review

98
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.68

A

312.68 - Inspection of investigator’s records and reports

99
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.69 - Handling of controlled substances
312.70 - Disqualification of a clinical investigator

A

312.69 - Handling of controlled substances

100
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart D - Responsibilities of Sponsors and Investigators
312.70

A

312.70 - Disqualification of a clinical investigator

101
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E

A

Subpart E - Drugs intended to treat life-threatening and severely debilitating Illnesses.

102
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.80

A

312.80 - Purpose

103
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.81

A

312.81 - Scope

104
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.82

A

312.82 - Early consultation

105
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.83

A

312.83 - Treatment protocols

106
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.84

A

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

107
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.85

A

312.85 - Phase 4 studies

108
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.86

A

312.86 - Focused FDA regulatory research

109
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.87

A

312.87 - Active monitoring of conduct and evaluation of clinical trials

110
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
312.88

A

312.88 - Safeguards for patient safety

111
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses
Subpart F

A

Subpart F - Miscellaneous

112
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart F - Miscellaneous
312.110

A

312.110 - Import and export requirements

113
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart F - Miscellaneous
312.120

A

312.120 - Foreign clinical studies not conducted under an IND

114
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart F - Miscellaneous
312.130

A

312.130 - Availability for public disclosure of data and information in an IND

115
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart F - Miscellaneous
312.140

A

312.140 - Address for correspondence

116
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart F - Miscellaneous
312.145

A

312.145 - Guidance documents

117
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart G

A

Subpart G - Drugs for Investigational Use in Laboratory Research Animals or Vitro Tests

118
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart G - Drugs for Investigational Use in Laboratory Research Animals or Vitro Tests
312.160

A

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

119
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart I

A

Subpart I - Expanded Access to Investigational Drugs for Treatment Use

120
Q

Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use
312.300

A

312.300 - General

121
Q

Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use
312.305

A

312.305 - Requirements for all expanded access uses

122
Q

Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use
312.310

A

312.310 - Individual patients, including for emergency use

123
Q

Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use
312.315

A

312.315 - Intermediate-size patient populations

124
Q

Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use
312.320

A

312.320 - Treatment IND or treatment protocol

125
Q

Title 21 Part 812

A

Part 812 - Investigational Device Exemptions

126
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A

A

Subpart A - General Provisions

127
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.1

A

812.1 - Scope

128
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.2

A

812.2 - Applicability

129
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.3

A

812.3 - Definitions

130
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.5 - Labeling of investigational devices
812.7 - Prohibition of promotion and other practices
812.10 - Waivers
812.18 - Import and export requirements
812.19 - Address for IDE correspondence

A

812.5 - Labeling of investigational devices

131
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.5

A

812.5 - Labeling of investigational devices

132
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.7

A

812.7 - Prohibition of promotion and other practices

133
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.10

A

812.10 - Waivers

134
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.18

A

812.18 - Import and export requirements

135
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart A - General Provisions
812.19

A

812.19 - Address for IDE correspondence

136
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B

A

Subpart B - Application and Administrative Action

137
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.20

A

812.20 - Application

138
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.25

A

812.25 - Investigational plan

139
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.27

A

812.27 - Report of prior investigations

140
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.28

A

812.28 - Acceptance of data from clinical investigations conducted outside the United States

141
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.30 - FDA action on applications
812.35 - Supplemental applications
812.36 - Treatment use of an investigational device
812.38 - Confidentiality of data and information

A

812.30 - FDA action on applications

142
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.35

A

812.35 - Supplemental applications

143
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.36

A

812.36 - Treatment use of an investigational device

144
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart B - Application and Administrative Action
812.38

A

812.38 - Confidentiality of data and information

145
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart C

A

Subpart C - Responsibilities of Sponsors

146
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart C - Responsibilities of Sponsors
812.40 - General responsibilities of sponsors
812.42 - FDA and IRB approval
812.43 - Selecting investigators and monitors
812.45 - Informing investigators
812.46 - Monitoring investigations
812.47 - Emergency research under 50.24 of this chapter

A

812.40 - General responsibilities of sponsors

147
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart C - Responsibilities of Sponsors
812.42

A

812.42 - FDA and IRB approval

148
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart C - Responsibilities of Sponsors
812.43

A

812.43 - Selecting investigators and monitors

149
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart C - Responsibilities of Sponsors
812.45

A

812.45 - Informing investigators

150
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart C - Responsibilities of Sponsors
812.46

A

812.46 - Monitoring investigations

151
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart C - Responsibilities of Sponsors
812.47

A

812.47 - Emergency research under 50.24 of this chapter

152
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart D - IRB Review and Approval

A

Subpart D - IRB Review and Approval

153
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart D - IRB Review and Approval
812.60

A

812.60 - IRB composition, duties, and functions

154
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart D - IRB Review and Approval
812.62

A

812.62 - IRB approval

155
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart D - IRB Review and Approval
812.64

A

812.64 - IRB’s continuing review

156
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart D - IRB Review and Approval
812.66

A

812.66 - Significant risk device determinations

157
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart E

A

Subpart E - Responsibilities of Investigators

158
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart E - Responsibilities of Investigators
812.100

A

812.100 - General responsibilities of investigators

159
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart E - Responsibilities of Investigators
812.110 - Specific responsibilities of investigators
812.119 - Disqualification of a clinical investigator

A

812.110 - Specific responsibilities of investigators

160
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart E - Responsibilities of Investigators
812.119

A

812.119 - Disqualification of a clinical investigator

161
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart G

A

Subpart G - Records and Reports

162
Q

Title 21 Part 812 - Investigational Device Exemptions
Subpart G - Records and Reports
812.140

A

812.140 - Records

SOCRA Questions (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions