Preferred Label : Study Reconstruction;
NCIt related terms : reconstruction (of a study);
NCIt definition : The process for eClinical trials where the FDA expects archival trial records that
support review of the data as well as the processes used for obtaining and managing
the data so that the trustworthiness of results can be evaluated. (FDA);
Alternative definition : CDISC-GLOSS: For eClinical trials FDA expects archival trial records to support review
of the data as well as the processes used for obtaining and managing the data so that
the trustworthiness of results obtained can be evaluated. NOTE: Reconstruction from
records should support evaluation of the operation and validity of computerized systems
and the conformance of the systems to applicable regulations during design and execution
of the trial as well as during the period of record retention. [from CSUCT VI D, 21
CFR Parts 11, 312];
NCI Metathesaurus CUI : CL540681;
Origin ID : C142712;
UMLS CUI : C4688650;
Semantic type(s)
- concept_is_in_subset
