Title 21 Code of Federal Regulations Part 56
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:appliesTo |
clinical investigations involving human subjects
|
| gptkbp:citation |
gptkb:21_CFR_Part_56
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:establishes |
requirements for IRB functions and operations
requirements for IRB membership requirements for IRB records requirements for IRB review of research requirements for IRB cooperation with FDA inspections requirements for IRB suspension or termination of approval requirements for IRB authority requirements for IRB continuing review requirements for IRB expedited review procedures requirements for IRB notification of findings requirements for IRB responsibilities requirements for IRB written procedures |
| https://www.w3.org/2000/01/rdf-schema#label |
Title 21 Code of Federal Regulations Part 56
|
| gptkbp:purpose |
protection of human subjects in clinical trials
|
| gptkbp:regulates |
gptkb:Institutional_Review_Boards
|
| gptkbp:relatedTo |
gptkb:Title_21_Code_of_Federal_Regulations_Part_50
|
| gptkbp:requires |
review and approval of research by IRBs
|
| gptkbp:bfsParent |
gptkb:21_CFR_56
|
| gptkbp:bfsLayer |
6
|