Preferred Label : Clinical Study Report;
NCIt definition : A written description of a study of any therapeutic, prophylactic, or diagnostic agent
conducted in human subjects, in which the clinical and statistical description, presentations,
and analysis are fully integrated into a single report. (ICH E6);
Alternative definition : CDISC-GLOSS: A written description of a study of any therapeutic, prophylactic, or
diagnostic agent conducted in human subjects, in which the clinical and statistical
description, presentations, and analysis are fully integrated into a single report.
NOTE: For further information, see the ICH Guideline for Structure and Content of
Clinical Study Reports. [ICH E6 Glossary];
NCI Metathesaurus CUI : CL540370;
Origin ID : C142439;
UMLS CUI : C4553084;
Semantic type(s)
- concept_is_in_subset
