Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:appliesTo |
applicable clinical trials
principal investigators of clinical trials sponsors of clinical trials |
| gptkbp:codifiedIn |
Title 42 of the Code of Federal Regulations
|
| gptkbp:enforcedBy |
gptkb:National_Institutes_of_Health
gptkb:U.S._Department_of_Health_and_Human_Services |
| https://www.w3.org/2000/01/rdf-schema#label |
42 CFR Part 11
|
| gptkbp:legalBasis |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| gptkbp:penalty |
civil monetary penalties
withholding of NIH grant funds |
| gptkbp:purpose |
increase transparency of clinical trials
|
| gptkbp:regulates |
clinical trial registration
clinical trial results reporting |
| gptkbp:requires |
timely updates to clinical trial records
submission of clinical trial information to ClinicalTrials.gov disclosure of informed consent documents submission of summary results information |
| gptkbp:section |
gptkb:law
|
| gptkbp:startDate |
January 18, 2017
|
| gptkbp:website |
https://prsinfo.clinicaltrials.gov/42-CFR-Part-11.html
|
| gptkbp:bfsParent |
gptkb:Final_Rule_(42_CFR_Part_11)
|
| gptkbp:bfsLayer |
7
|