Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:appliesTo |
clinical trials
pharmaceutical companies sponsors of drug studies |
| gptkbp:covers |
protocol amendments
recordkeeping investigator responsibilities safety reporting sponsor responsibilities IND inactivation and withdrawal inspection of records requirements for IND submission |
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA 21 CFR Part 312
|
| gptkbp:jurisdiction |
gptkb:United_States
|
| gptkbp:legalCitation |
gptkb:21_CFR_Part_312
|
| gptkbp:partOf |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:regulates |
Investigational New Drug Application
|
| gptkbp:relatedTo |
FDA regulations
drug development process |
| gptkbp:startDate |
1987
|
| gptkbp:bfsParent |
gptkb:Good_Clinical_Practice_(GCP)
|
| gptkbp:bfsLayer |
7
|