Statements (31)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:abbreviation |
gptkb:International_Council_for_Harmonisation_-_Good_Clinical_Practice
|
| gptkbp:appliesTo |
clinical research
pharmaceutical research |
| gptkbp:basisFor |
regulatory requirements for clinical trials
|
| gptkbp:category |
medical guideline
clinical research regulation |
| gptkbp:firstPublished |
1996
|
| gptkbp:focusesOn |
clinical trials
good clinical practice |
| gptkbp:fullName |
gptkb:International_Council_for_Harmonisation_-_Good_Clinical_Practice
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH-GCP
|
| gptkbp:includes |
guidance on ethics committee
guidance on informed consent guidance on investigator responsibilities guidance on monitoring guidance on record keeping guidance on reporting guidance on sponsor responsibilities guidance on trial protocol |
| gptkbp:latestReleaseVersion |
gptkb:E6(R2)
2016 |
| gptkbp:publishedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:purpose |
to ensure credibility of clinical trial data
to ensure the safety, rights, and well-being of clinical trial subjects |
| gptkbp:usedIn |
gptkb:Europe
gptkb:Japan gptkb:United_States many other countries |
| gptkbp:bfsParent |
gptkb:clinical_trial
|
| gptkbp:bfsLayer |
6
|