Statements (29)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:National_Library_of_Medicine
|
| gptkbp:appliesTo |
applicable clinical trials
clinical trials of FDA-regulated biological products clinical trials of FDA-regulated devices clinical trials of FDA-regulated drugs sponsors of applicable clinical trials principal investigators of applicable clinical trials |
| gptkbp:codifiedIn |
gptkb:42_CFR_Part_11
|
| gptkbp:enforcedBy |
gptkb:National_Institutes_of_Health
gptkb:U.S._Food_and_Drug_Administration |
| https://www.w3.org/2000/01/rdf-schema#label |
Final Rule 42 CFR Part 11
|
| gptkbp:mandate |
public posting of clinical trial results
timely updates to clinical trial records |
| gptkbp:penalty |
civil monetary penalties
withholding of federal funds |
| gptkbp:publishedIn |
gptkb:Federal_Register
|
| gptkbp:purpose |
improve public access to clinical trial data
increase transparency of clinical trial information |
| gptkbp:regulates |
clinical trial registration
clinical trial results reporting |
| gptkbp:relatedTo |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| gptkbp:requires |
submission of clinical trial information to ClinicalTrials.gov
disclosure of adverse event information disclosure of summary results information disclosure of protocol and statistical analysis plan |
| gptkbp:startDate |
January 18, 2017
|
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration_Amendments_Act_Section_801
|
| gptkbp:bfsLayer |
7
|