Preferred Label : Study Audit;
NCIt definition : A systematic and independent examination of study-related activities and documents
to determine whether the evaluated trial-related activities were conducted, and the
data were recorded, analyzed, and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), good clinical practice (GCP), and the applicable
regulatory requirement(s). (ICH E6 Glossary);
Alternative definition : CDISC: A systematic and independent examination of study-related activities and documents
to determine whether the evaluated trial-related activities were conducted and the
data were recorded, analyzed, and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), good clinical practice (GCP), and the applicable
regulatory requirement(s). (ICH E6 Glossary);
NCI Metathesaurus CUI : CL1772571;
Origin ID : C184396;
UMLS CUI : C5669252;
Semantic type(s)
- concept_is_in_subset
