Statements (45)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:allows |
Expedited review procedures
|
| gptkbp:appliesTo |
Biologic product studies
Clinical investigations regulated by FDA Device studies Drug studies |
| gptkbp:authority |
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381
|
| gptkbp:citation |
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56
|
| gptkbp:codifiedIn |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:excludes |
Certain emergency use situations
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR Part 56
|
| gptkbp:prohibits |
Conflict of interest in IRB members
|
| gptkbp:providesFor |
IRB suspension or termination of approval
|
| gptkbp:purpose |
Protection of human subjects in clinical investigations
|
| gptkbp:regulates |
gptkb:Institutional_Review_Boards
|
| gptkbp:relatedTo |
gptkb:21_CFR_Part_50
|
| gptkbp:requires |
Continuing review of research
IRB membership diversity IRB records retention IRB review and approval of research Informed consent documentation Reporting of unanticipated problems |
| gptkbp:section |
56.112
56.115 56.122 56.113 56.101 56.102 56.103 56.104 56.105 56.107 56.108 56.109 56.110 56.111 56.114 56.120 56.121 56.123 56.124 |
| gptkbp:startDate |
January 27, 1981
|
| gptkbp:bfsParent |
gptkb:Title_21_Code_of_Federal_Regulations_Part_56
|
| gptkbp:bfsLayer |
7
|