Preferred Label : Real-world Data;
NCIt synonyms : RWD;
NCIt related terms : Real-World Data (RWD); Real World Data; Real World Data (RWD);
NCIt definition : Data relating to patient health status and/or the delivery of health care routinely
collected from sources other than traditional clinical trials. Examples of sources
include data derived from electronic health records (EHRs); medical claims and billing
data; data from product and disease registries; patient-generated data, including
from in-home-use settings; and data gathered from other sources that can inform on
health status, such as mobile devices. (21 U.S.C. 355g(b)).5 and Framework for FDA's
Real-World Evidence Program December 2018);
Alternative definition : CDISC-GLOSS: Data relating to patient health status and/or the delivery of health
care routinely collected from sources other than traditional clinical trials. NOTE:
Examples of sources include data derived from electronic health records (EHRs); medical
claims and billing data; data from product and disease registries; patient-generated
data, including from in-home-use settings; and data gathered from other sources that
can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and
Framework for FDA's Real-World Evidence Program December 2018; FDA Draft Guidance,
Data Standards for Drug and Biological Product Submissions Containing Real-World Data,
OCTOBER 2021] See also Real-World Evidence (RWE); CDISC: Data relating to patient health status and/or the delivery of health care routinely
collected from sources other than traditional clinical trials. NOTE: Examples of sources
include data derived from electronic health records (EHRs); medical claims and billing
data; data from product and disease registries; patient-generated data, including
from in-home-use settings; and data gathered from other sources that can inform on
health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for
FDA's Real-World Evidence Program December 2018] See also Real-World Evidence (RWE); MRCT-Ctr: Information from many different sources used for health research purposes.
(https://mrctcenter.org/glossaryterm/real-world-data-rwd/);
NCI Metathesaurus CUI : CL979052;
Origin ID : C165830;
UMLS CUI : C5237471;
See also inter- (CISMeF)
- Semantic type(s)
- concept_is_in_subset
