Statements (12)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:appliesTo |
nonclinical laboratory studies
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR 58.190
|
| gptkbp:location |
Title 21, Code of Federal Regulations
|
| gptkbp:partOf |
gptkb:21_CFR_Part_58
|
| gptkbp:regulates |
storage and retention of records
|
| gptkbp:requires |
records to be retained for at least 2 years after FDA approval or study termination
retention of raw data, documentation, protocols, specimens, and final reports |
| gptkbp:startDate |
gptkb:United_States
|
| gptkbp:bfsParent |
gptkb:21_CFR_Part_58
|
| gptkbp:bfsLayer |
7
|