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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
21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations 50.52
50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects
26
21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations 50.53
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
27
21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations 50.54
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
28
21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations 50.55
50.55 - Requirements for permission by parents or guardians and for assent by children
29
21 CFR 50 Subpart D - Additional Safeguards for Children in Clinical Investigations 50.56
50.56 - Wards
30
Title 21 Part 56
Institutional Review Boards
31
Title 21 Part 56 - Institutional Review Boards Subpart A
Subpart A - General Provisions
32
Title 21 Part 56 - Institutional Review Board Subpart A - General Provisions 56.101
56.101 - Scope
33
Title 21 Part 56 - Institutional Review Board Subpart A - General Provisions 56.102
56.102 - Definitions
34
Title 21 Part 56 - Institutional Review Board Subpart A - General Provisions 56.103
56.103 - Circumstances in which IRB review is required
35
Title 21 Part 56 - Institutional Review Board Subpart A - General Provisions 56.104
56.104 - Exemptions from IRB requirement
36
Title 21 Part 56_____ Subpart A______ 56.105
56.105 - Waiver of IRB requirement
37
Title 21 Part 56 - Institutional Review Board Subpart B - ?
Subpart B - Organization and Personnel
38
Title 21 Part 56 - Subpart B - 56.106 - ?
Part 56 Institutional Review Board Sub part B Organization and Personnel 56.106 - Registration
39
Title 21 Part 56 - _______ Subpart B_______ 56.107 - ?
Part 56 - IRBs Subpart B - Organization and Personnel 56.107 - IRB Membership
40
Title 21 Part 56 - Institutional Review Board Subpart C
Subpart C - IRB Functions and Operations
41
Title 21 Part 56 - Institutional Review Board Subpart C - - IRB Functions and Operations 56.108
56.108 - IRB functions and operations
42
Title 21 Part 56 - Institutional Review Board Subpart C - - IRB Functions and Operations 56.109
56.109 - IRB review of research
43
Title 21 Part 56 - Institutional Review Board Subpart C - - IRB Functions and Operations 56.110
56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research
44
Title 21 Part 56 - Institutional Review Board Subpart C - - IRB Functions and Operations 56.111
56.111 - Criteria for IRB approval of research
45
Title 21 Part 56 - Institutional Review Board Subpart C - - IRB Functions and Operations 56.112
56.112 - Review by institution
46
Title 21 Part 56 - Institutional Review Board Subpart C - - IRB Functions and Operations 56.113
56.113 - Suspension or termination of IRB approval of research
47
Title 21 Part 56 - Institutional Review Board Subpart C - - IRB Functions and Operations 56.114
56.114 - Cooperative research
48
Title 21 Part 56 - Institutional Review Board Subpart D
Subpart D - Records and Reports
49
Title 21 Part 56 - Institutional Review Board Subpart D 56.115
56.115 - IRB records
50
Title 21 Part 56 - Institutional Review Board Subpart E
Subpart E - Administrative Actions for Noncompliance
51
Title 21 Part 56 - Institutional Review Board Subpart E - Administrative Actions for Noncompliance 56.120
56.120 - Lesser administrative actions
52
Title 21 Part 56 - Institutional Review Board Subpart E - Administrative Actions for Noncompliance 56.121
56.121 -Disqualification of an IRB or an institution
53
Title 21 Part 56 - Institutional Review Board Subpart E - Administrative Actions for Noncompliance 56.122
56.122 - Public disclosure of information regarding revocation
54
Title 21 Part 56 - Institutional Review Board Subpart E - Administrative Actions for Noncompliance 56.123
56.123 - Reinstatement of an IRB or an institution
55
Title 21 Part 56 - Institutional Review Board Subpart E - Administrative Actions for Noncompliance 56.124
56.124 - Actions alternative or additional to disqualification
56
Title 21 Part 312
Part 312 - Investigational New Drug Application
57
Title 21 Part 312 - Investigational New Drug Application Subpart A
Subpart A - General Provisions
58
Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions 312.1
312.1 - Scope
59
Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions 312.2
312.2 - Applicability
60
Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions 312.3
312.3 - Definitions and interpretations
61
Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions 312.6
312.6- Labeling of an investigational new drug
62
Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions 312.7
312.7 - Promotion of investigational drugs
63
Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions 312.8
312.8 - Charging for investigational drugs under an IND
64
Title 21 Part 312 - Investigational New Drug Application Subpart A - General Provisions 312.10
312.10 - Waivers
65
Title 21 Part 312 - Investigational New Drug Application Subpart B
Subpart B - Investigational New Drug Application (IND)
66
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.20
312.20 - Requirement of an IND
67
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.21 - Phases of an investigation
312.21 - Phases of an investigation
68
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.22
312.22 - General principles of the IND submission
69
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.23
312.23 - IND content and format
70
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.30
312.30 - Protocol amendments
71
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.31 - Information amendments
312.31 - Information amendments
72
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.32
312.32 - IND Safety Reporting
73
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.33 - Annual Reports
312.33 - Annual Reports
74
Title 21 Part 312 - Investigational New Drug Application Subpart B - Investigational New Drug Application (IND) 312.38
312.38 - Withdrawal of an IND
75
Title 21 Part 312 - Investigational New Drug Application Subpart C
Subpart C - Administrative Actions
76
Title 21 Part 312 - Investigational New Drug Application Subpart C - Administrative Actions 312.40
312.40 - General requirements for use of an investigational new drug in a clinical investigation
77
Title 21 Part 312 - Investigational New Drug Application Subpart C - Administrative Actions 312.41
312.41 - Comment and advice on an IND
78
Title 21 Part 312 - Investigational New Drug Application Subpart C - Administrative Actions 312.42
312.42 - Clinical holds and requests for modification
79
Title 21 Part 312 - Investigational New Drug Application Subpart C - Administrative Actions 312.44
312.44 - Termination
80
Title 21 Part 312 - Investigational New Drug Application Subpart C - Administrative Actions 312.45
312.45 - Inactive status
81
Title 21 Part 312 - Investigational New Drug Application Subpart C - Administrative Actions 312.47
312.47 - Meetings
82
Title 21 Part 312 - Investigational New Drug Application Subpart C - Administrative Actions 312.48
312.48 - Dispute resolution
83
Title 21 Part 312 - Investigational New Drug Application Subpart D
Subpart D - Responsibilities of Sponsors and Investigators
84
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.50
312.50 - General responsibilities of sponsors
85
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.52
312.52 - Transfer of obligations to a contract research organization
86
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.53
312.53 - Selecting investigators and monitors
87
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.54
312.54 - Emergency research under §50.24 of this chapter
88
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.55
312.55 - Informing investigators
89
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.56
312.56 - Review of ongoing investigations
90
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.57
312.57 - Recordkeeping and record retention
91
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.58
312.58 - Inspection of sponsor's records and reports
92
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.59
312.59 - Disposition of unused supply of investigational drug
93
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.60
312.60 - General responsibilities of investigators
94
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.61
312.61 - Control of the investigational drug
95
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.62
312.62 - Investigator recordkeeping and record retention
96
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.64
312.64 - Investigator reports
97
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.66
312.66 - Assurance of IRB review
98
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.68
312.68 - Inspection of investigator's records and reports
99
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
312.69 - Handling of controlled substances
100
Title 21 Part 312 - Investigational New Drug Application Subpart D - Responsibilities of Sponsors and Investigators 312.70
312.70 - Disqualification of a clinical investigator
101
Title 21 Part 312 - Investigational New Drug Application Subpart E
Subpart E - Drugs intended to treat life-threatening and severely debilitating Illnesses.
102
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.80
312.80 - Purpose
103
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.81
312.81 - Scope
104
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.82
312.82 - Early consultation
105
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.83
312.83 - Treatment protocols
106
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.84
312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses
107
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.85
312.85 - Phase 4 studies
108
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.86
312.86 - Focused FDA regulatory research
109
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.87
312.87 - Active monitoring of conduct and evaluation of clinical trials
110
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses 312.88
312.88 - Safeguards for patient safety
111
Title 21 Part 312 - Investigational New Drug Application Subpart E - Drugs intended to treat life-threatening and severely-debilitating Illnesses Subpart F
Subpart F - Miscellaneous
112
Title 21 Part 312 - Investigational New Drug Application Subpart F - Miscellaneous 312.110
312.110 - Import and export requirements
113
Title 21 Part 312 - Investigational New Drug Application Subpart F - Miscellaneous 312.120
312.120 - Foreign clinical studies not conducted under an IND
114
Title 21 Part 312 - Investigational New Drug Application Subpart F - Miscellaneous 312.130
312.130 - Availability for public disclosure of data and information in an IND
115
Title 21 Part 312 - Investigational New Drug Application Subpart F - Miscellaneous 312.140
312.140 - Address for correspondence
116
Title 21 Part 312 - Investigational New Drug Application Subpart F - Miscellaneous 312.145
312.145 - Guidance documents
117
Title 21 Part 312 - Investigational New Drug Application Subpart G
Subpart G - Drugs for Investigational Use in Laboratory Research Animals or Vitro Tests
118
Title 21 Part 312 - Investigational New Drug Application Subpart G - Drugs for Investigational Use in Laboratory Research Animals or Vitro Tests 312.160
312.160 - Drugs for investigational use in laboratory research animals or in vitro tests
119
Title 21 Part 312 - Investigational New Drug Application Subpart I
Subpart I - Expanded Access to Investigational Drugs for Treatment Use
120
Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use 312.300
312.300 - General
121
Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use 312.305
312.305 - Requirements for all expanded access uses
122
Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use 312.310
312.310 - Individual patients, including for emergency use
123
Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use 312.315
312.315 - Intermediate-size patient populations
124
Title 21 Part 312 - Investigational New Drug Application Subpart I - Expanded Access to Investigational Drugs for Treatment Use 312.320
312.320 - Treatment IND or treatment protocol
125
Title 21 Part 812
Part 812 - Investigational Device Exemptions
126
Title 21 Part 812 - Investigational Device Exemptions Subpart A
Subpart A - General Provisions
127
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.1
812.1 - Scope
128
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.2
812.2 - Applicability
129
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.3
812.3 - Definitions
130
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
812.5 - Labeling of investigational devices
131
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.5
812.5 - Labeling of investigational devices
132
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.7
812.7 - Prohibition of promotion and other practices
133
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.10
812.10 - Waivers
134
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.18
812.18 - Import and export requirements
135
Title 21 Part 812 - Investigational Device Exemptions Subpart A - General Provisions 812.19
812.19 - Address for IDE correspondence
136
Title 21 Part 812 - Investigational Device Exemptions Subpart B
Subpart B - Application and Administrative Action
137
Title 21 Part 812 - Investigational Device Exemptions Subpart B - Application and Administrative Action 812.20
812.20 - Application
138
Title 21 Part 812 - Investigational Device Exemptions Subpart B - Application and Administrative Action 812.25
812.25 - Investigational plan
139
Title 21 Part 812 - Investigational Device Exemptions Subpart B - Application and Administrative Action 812.27
812.27 - Report of prior investigations
140
Title 21 Part 812 - Investigational Device Exemptions Subpart B - Application and Administrative Action 812.28
812.28 - Acceptance of data from clinical investigations conducted outside the United States
141
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
812.30 - FDA action on applications
142
Title 21 Part 812 - Investigational Device Exemptions Subpart B - Application and Administrative Action 812.35
812.35 - Supplemental applications
143
Title 21 Part 812 - Investigational Device Exemptions Subpart B - Application and Administrative Action 812.36
812.36 - Treatment use of an investigational device
144
Title 21 Part 812 - Investigational Device Exemptions Subpart B - Application and Administrative Action 812.38
812.38 - Confidentiality of data and information
145
Title 21 Part 812 - Investigational Device Exemptions Subpart C
Subpart C - Responsibilities of Sponsors
146
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
812.40 - General responsibilities of sponsors
147
Title 21 Part 812 - Investigational Device Exemptions Subpart C - Responsibilities of Sponsors 812.42
812.42 - FDA and IRB approval
148
Title 21 Part 812 - Investigational Device Exemptions Subpart C - Responsibilities of Sponsors 812.43
812.43 - Selecting investigators and monitors
149
Title 21 Part 812 - Investigational Device Exemptions Subpart C - Responsibilities of Sponsors 812.45
812.45 - Informing investigators
150
Title 21 Part 812 - Investigational Device Exemptions Subpart C - Responsibilities of Sponsors 812.46
812.46 - Monitoring investigations
151
Title 21 Part 812 - Investigational Device Exemptions Subpart C - Responsibilities of Sponsors 812.47
812.47 - Emergency research under 50.24 of this chapter
152
Title 21 Part 812 - Investigational Device Exemptions Subpart D - IRB Review and Approval
Subpart D - IRB Review and Approval
153
Title 21 Part 812 - Investigational Device Exemptions Subpart D - IRB Review and Approval 812.60
812.60 - IRB composition, duties, and functions
154
Title 21 Part 812 - Investigational Device Exemptions Subpart D - IRB Review and Approval 812.62
812.62 - IRB approval
155
Title 21 Part 812 - Investigational Device Exemptions Subpart D - IRB Review and Approval 812.64
812.64 - IRB's continuing review
156
Title 21 Part 812 - Investigational Device Exemptions Subpart D - IRB Review and Approval 812.66
812.66 - Significant risk device determinations
157
Title 21 Part 812 - Investigational Device Exemptions Subpart E
Subpart E - Responsibilities of Investigators
158
Title 21 Part 812 - Investigational Device Exemptions Subpart E - Responsibilities of Investigators 812.100
812.100 - General responsibilities of investigators
159
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
812.110 - Specific responsibilities of investigators
160
Title 21 Part 812 - Investigational Device Exemptions Subpart E - Responsibilities of Investigators 812.119
812.119 - Disqualification of a clinical investigator
161
Title 21 Part 812 - Investigational Device Exemptions Subpart G
Subpart G - Records and Reports
162
Title 21 Part 812 - Investigational Device Exemptions Subpart G - Records and Reports 812.140
812.140 - Records
163

SOCRA Questions (6 decks)

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