Preferred Label : Essential Trial Document;
NCIt related terms : essential documents;
NCIt definition : A document that demonstrates the compliance of the investigator, sponsor, and monitor
of a clinical trial with all applicable regulatory requirements and the standards
of Good Clinical Practice.;
Alternative definition : CDISC-GLOSS: Documents that individually and collectively permit evaluation of the
conduct of a study and the quality of the data produced. [ICH E6 Glossary];
NCI Metathesaurus CUI : CL540507;
Origin ID : C142540;
UMLS CUI : C4684659;
Semantic type(s)
- concept_is_in_subset
