Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:appliesTo |
gptkb:ClinicalTrials.gov
applicable clinical trials |
| gptkbp:codifiedIn |
gptkb:42_CFR_Part_11
|
| gptkbp:enforcedBy |
gptkb:National_Institutes_of_Health
gptkb:U.S._Department_of_Health_and_Human_Services |
| gptkbp:legalBasis |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| gptkbp:publishedIn |
gptkb:Federal_Register
|
| gptkbp:purpose |
increase transparency of clinical trials
improve public access to clinical trial information |
| gptkbp:regulates |
clinical trial registration
clinical trial results reporting |
| gptkbp:relatedTo |
gptkb:ClinicalTrials.gov
|
| gptkbp:requires |
submission of clinical trial information
summary results reporting timely updates to clinical trial records |
| gptkbp:startDate |
January 18, 2017
|
| gptkbp:subject |
penalties for noncompliance
|
| gptkbp:website |
https://prsinfo.clinicaltrials.gov/
|
| gptkbp:bfsParent |
gptkb:FDAAA_801
|
| gptkbp:bfsLayer |
6
|
| http://www.w3.org/2000/01/rdf-schema#label |
Final Rule (42 CFR Part 11)
|