Final Rule (42 CFR Part 11)

URI: https://gptkb.org/entity/Final_Rule_(42_CFR_Part_11)
GPTKB entity
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
https://www.w3.org/2000/01/rdf-schema#label Final Rule (42 CFR Part 11)
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