|
gptkbp:instanceOf
|
gptkb:United_States_federal_law
|
|
gptkbp:affects
|
principal investigators of clinical trials
sponsors of clinical trials
|
|
gptkbp:appliesTo
|
applicable clinical trials
|
|
gptkbp:codifiedIn
|
gptkb:42_U.S.C._§_282(j)
|
|
gptkbp:dateEnacted
|
2007
|
|
gptkbp:enactedBy
|
gptkb:United_States_Congress
|
|
gptkbp:enforcedBy
|
gptkb:U.S._Food_and_Drug_Administration
|
|
gptkbp:fullName
|
gptkb:Food_and_Drug_Administration_Amendments_Act_Section_801
|
|
gptkbp:goal
|
increase transparency in clinical research
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
FDAAA 801
|
|
gptkbp:partOf
|
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
|
gptkbp:penalty
|
monetary fines
withholding of NIH grant funds
|
|
gptkbp:regulates
|
clinical trial registration
clinical trial results reporting
|
|
gptkbp:relatedTo
|
gptkb:ClinicalTrials.gov
gptkb:Final_Rule_(42_CFR_Part_11)
gptkb:NIH_Policy_on_Dissemination_of_NIH-Funded_Clinical_Trial_Information
|
|
gptkbp:requires
|
submission of summary results to ClinicalTrials.gov
registration of certain clinical trials on ClinicalTrials.gov
|
|
gptkbp:bfsParent
|
gptkb:ClinicalTrials.gov
|
|
gptkbp:bfsLayer
|
5
|