Preferred Label : Control of Electronic Records;
NCIt synonyms : Electronic Records Control;
NCIt definition : The process by which electronic records are created and maintained in a database for
regulated clinical investigations such that the data can be considered adequate and
accurate.;
Alternative definition : CDISC-GLOSS: To prepare and maintain case histories and other records for regulated
clinical investigations or other regulated research. NOTE: Control is often used as
a casual synonym for the terms in 21 CFR 312.62 requiring investigative sites to prepare,
maintain, and retain adequate and accurate case histories. [After 1. 21 CFR 11; 2.
CSUCT] See also record.;
NCI Metathesaurus CUI : CL540453;
Origin ID : C142464;
UMLS CUI : C4553531;
Semantic type(s)
- concept_is_in_subset
