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SOCRA Questions > Code of Federal Regulations > Flashcards

Code of Federal Regulations Flashcards

1
Q

Title 21

A

Food and Drugs

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2
Q

21 CFR 11

A

Electronic Records, Electronic Signatures

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3
Q

21 CFR 11 Subpart A ______
11.1_______

A

Subpart A - General Provisions
11.1 - Scope

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4
Q

21 CFR 11 Subpart A ______
11.2_______

A

Subpart A - General Provisions
11.2 - Implementation

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5
Q

21 CFR 11 Subpart A ______
11.3_______

A

Subpart A - General Provisions
11.3 - Definitions

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6
Q

21 CFR 11 Subpart B

A

Electronic Records

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7
Q

21 CFR 11 Subpart B_______ 11.10____

A

Subpart B—Electronic Records
11.10 Controls for closed systems.

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8
Q

21 CFR 11 Subpart C

A

Electronic Signatures

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9
Q

21 CFR 11 Subpart B ______
11.30_______

A

Subpart B - Electronic Records
11.30 - Controls for closed systems

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10
Q

21 CFR 11 Subpart C ______
11.100_______

A

Subpart C - Electronic Signatures
11.100 - General requirements

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11
Q

21 CFR 11 Subpart C____
11.200______

A

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

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12
Q

21 CFR 11 Subpart C _______
11.300_________

A

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

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13
Q

21 CFR 50

A

Part 50 - Protection of Human Subjects

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14
Q

21 CFR 50 Subpart A

A

General Provisions

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15
Q

21 CFR 50 Subpart A General Provisions
50.1

A

21 CFR 50 Subpart A General Provisions
50.1 - Scope

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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

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17
Q

21 CFR 50 Subpart B

A

Informed Consent

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18
Q

21 CFR 50 Subpart B Informed Consent
50.20

A

50.20 - General requirements for informed consent

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19
Q

21 CFR 50 Subpart B Informed Consent
50.23

A

50.23 - Exception for general requirements

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20
Q

21 CFR 50 Subpart B ______
50.24______

A

50.24 - Exception from informed consent requirements for emergency research

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21
Q

21 CFR 50 Subpart B Informed Consent
50.25

A

50.25 - Elements of informed consent

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22
Q

21 CFR 50 Subpart B Informed Consent
50.27

A

50.27 - Documentation of informed consent

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23
Q

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

A

50.50 - IRB Duties

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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

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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

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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

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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

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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

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29
Q

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

A

50.56 - Wards

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30
Q

Title 21 Part 56

A

Institutional Review Boards

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31
Q

Title 21 Part 56 - Institutional Review Boards
Subpart A

A

Subpart A - General Provisions

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32
Q

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

A

56.101 - Scope

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33
Q

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

A

56.102 - Definitions

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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

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35
Q

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

A

56.104 - Exemptions from IRB requirement

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36
Q

Title 21 Part 56_____
Subpart A______
56.105

A

56.105 - Waiver of IRB requirement

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37
Q

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

A

Subpart B - Organization and Personnel

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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

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39
Q

Title 21 Part 56 - _______
Subpart B_______
56.107 - ?

A

Part 56 - IRBs

Subpart B - Organization and Personnel
56.107 - IRB Membership

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40
Q

Title 21 Part 56 - Institutional Review Board
Subpart C

A

Subpart C - IRB Functions and Operations

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41
Q

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

A

56.108 - IRB functions and operations

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42
Q

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

A

56.109 - IRB review of research

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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

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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

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45
Q

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

A

56.112 - Review by institution

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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

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47
Q

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

A

56.114 - Cooperative research

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48
Q

Title 21 Part 56 - Institutional Review Board
Subpart D

A

Subpart D - Records and Reports

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49
Q

Title 21 Part 56 - Institutional Review Board
Subpart D
56.115

A

56.115 - IRB records

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50
Q

Title 21 Part 56 - Institutional Review Board
Subpart E

A

Subpart E - Administrative Actions for Noncompliance

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51
Q

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

A

56.120 - Lesser administrative actions

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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

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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

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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

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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

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56
Q

Title 21 Part 312

A

Part 312 - Investigational New Drug Application

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57
Q

Title 21 Part 312 - Investigational New Drug Application Subpart A

A

Subpart A - General Provisions

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58
Q

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

A

312.1 - Scope

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59
Q

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

A

312.2 - Applicability

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60
Q

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

A

312.3 - Definitions and interpretations

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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

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62
Q

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

A

312.7 - Promotion of investigational drugs

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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

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64
Q

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

A

312.10 - Waivers

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65
Q

Title 21 Part 312 - Investigational New Drug Application
Subpart B

A

Subpart B - Investigational New Drug Application (IND)

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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

163
Q
A

SOCRA Questions (6 decks)

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