Preferred Label : Electronic Clinical Trial;
NCIt related terms : eClinical study; eClinical trial; eClinical investigation;
NCIt definition : A clinical trial in which computerized systems are used to plan, collect, access,
exchange, and archive data.;
Alternative definition : CDISC-GLOSS: Clinical trial in which primarily electronic processes are used to plan,
collect (acquire), access, exchange, and archive data required for conduct, management,
analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between
studies and trials. Both words refer to systematic efforts to obtain evidence relevant
to regulatory authorities, but, depending on regulatory context and particularly in
the case of postmarketing commitments, a study might not be the appropriate word for
a clinical trial (prospective, controlled, randomized), but should be reserved instead
for surveillance, structured gathering of information, epidemiological studies, or
even animal studies [Guidance for industry Postmarketing studies and Clinical Trials-implementation
of section 505(o) of the Federal Food, Drug, and Cosmetic act]. See also clinical
study, clinical trial.;
NCI Metathesaurus CUI : CL540519;
Origin ID : C142526;
UMLS CUI : C4684652;
Semantic type(s)
- concept_is_in_subset
