Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:abbreviation |
gptkb:ICH_E6(R2)
|
| gptkbp:appliesTo |
clinical trials
|
| gptkbp:focusesOn |
data integrity
protection of human subjects quality management in clinical trials responsibilities of sponsors and investigators risk-based approach to clinical trial management |
| gptkbp:fullName |
International Council for Harmonisation Guideline for Good Clinical Practice E6(R2)
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH E6(R2)
|
| gptkbp:language |
English
|
| gptkbp:partOf |
gptkb:ICH_Guidelines
|
| gptkbp:publishedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:purpose |
to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions
|
| gptkbp:releaseDate |
2016
|
| gptkbp:replacedBy |
ICH E6(R1)
ICH E6(R3) (draft as of 2024) |
| gptkbp:status |
in force
|
| gptkbp:subject |
gptkb:Good_Clinical_Practice
|
| gptkbp:url |
https://www.ich.org/page/efficacy-guidelines
|
| gptkbp:bfsParent |
gptkb:Good_Clinical_Practice_Guidelines
gptkb:Good_Clinical_Practice |
| gptkbp:bfsLayer |
7
|