Clinical Trial Authorisation Procedure
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:application |
sponsor of clinical trial
|
| gptkbp:appliesTo |
clinical trials
interventional clinical trials |
| gptkbp:compatibleWith |
non-interventional studies
|
| gptkbp:duration |
varies by country
|
| https://www.w3.org/2000/01/rdf-schema#label |
Clinical Trial Authorisation Procedure
|
| gptkbp:involves |
assessment by regulatory authorities
ethics committee review submission of clinical trial application |
| gptkbp:legalBasis |
gptkb:EU_Clinical_Trials_Directive_2001/20/EC
gptkb:EU_Clinical_Trials_Regulation_(EU)_No_536/2014 |
| gptkbp:purpose |
ensure safety and rights of trial participants
ensure scientific validity of clinical trials |
| gptkbp:regulates |
gptkb:European_Medicines_Agency
national competent authorities |
| gptkbp:requires |
gptkb:European_Union
additional information from applicant commencement of clinical trial |
| gptkbp:result |
authorisation granted
authorisation refused |
| gptkbp:bfsParent |
gptkb:CTAP
|
| gptkbp:bfsLayer |
5
|