Regulatory
Scope |
Individual
Subpart |
Subpart Title |
21 CFR
Section |
Number of
Infractions |
Number of Subsections
the Infractions
Cover |
Protection
of Human
Subjects |
|
General |
§50 |
63 |
1 |
| Subpart B |
Mandate to Obtain Informed Consent |
§50.20 |
59 |
1 |
| Exception from General Requirements |
§50.23 |
2 |
1 |
| Exception from General Requirements - Emergency Research |
§50.24 |
1 |
1 |
| Elements of Informed Consent |
§50.25 |
34 |
10 |
| Documentation of Informed Consent |
§50.27 |
55 |
3 |
| Subpart D |
Documentation of Permission by Parents/Legally Authorized Representative |
§50.55 |
1 |
1 |
| General - IDE |
§812 |
3 |
1 |
| IDE |
Subpart A |
Labeling of Investigational Devices |
§812.5 |
1 |
1 |
| Requirement for FDA & IRB Approval |
§812.18 |
1 |
1 |
| Subpart B |
IDE Application |
§812.20 |
1 |
1 |
| Investigational Plan |
§812.25 |
3 |
2 |
| Supplemental Actions |
§812.35 |
6 |
3 |
| Subpart C |
General Responsibilities of Sponsors |
§812.40 |
10 |
1 |
| FDA and IRB Approval |
§812.42 |
6 |
1 |
| Selecting Investigators and Monitors |
§812.43 |
11 |
5 |
| Monitoring Investigations |
§812.46 |
3 |
1 |
| Subpart D |
IRB Approval |
§812.62 |
2 |
1 |
| IRB’s Continuing Review |
§812.64 |
1 |
1 |
| Subpart E |
General Responsibilities of Investigators |
§812.100 |
170 |
2 |
| Specific Responsibilities of Investigators |
§812.110 |
147 |
6 |
| Subpart G |
Records |
§812.140 |
191* |
18 |
| Inspections |
§812.145 |
3 |
2 |
| Reports |
§812.150 |
91 |
15 |
| IND |
Subpart A |
Promotion of an investigational new drug |
§312.7 |
1 |
1 |
| Subpart B |
Requirement for an IND |
§312.20 |
8 |
3 |
| IND Content and Format |
§312.23 |
2 |
2 |
| Protocol Amendments |
§312.30 |
1 |
1 |
| IND Safety Reporting |
§312.32 |
2 |
2 |
| Annual Reports |
§312.33 |
4 |
3 |
| Subpart C |
General Requirements for Use of an IND in a Clinical Investigation |
§312.40 |
8 |
3 |
| Clinical Holds and Requests for Modifications |
§312.42 |
1 |
1 |
| Subpart D |
General Responsibilities of Sponsors |
§312.50 |
7 |
1 |
| Selecting Investigators and Monitors |
§312.53 |
17 |
11 |
| Informing Investigators |
§312.55 |
1 |
1 |
| Review of Ongoing Investigations |
§312.56 |
8 |
4 |
| Recordkeeping and Record Retention |
§312.57 |
8 |
3 |
| Inspection of Sponsor’s Records and Reports |
§312.58 |
1 |
1 |
| General Responsibilities of Investigators |
§312.60 |
216 |
1 |
| Investigator Recordkeeping and Retention |
§312.62 |
160 |
4 |
| Investigator Reports |
§312.64 |
11 |
3 |
| Assurance of IRB Review |
§312.66 |
65 |
1 |
| Disqualification of a Clinical Investigator |
§312.70 |
2 |
1 |
