Preferred Label : Clinical Trial Statistical Analysis Plan Documentation;
NCIt related terms : SAP; SA Plan; Statistical Analysis Plan;
Alternative definition : CareLex: A documented description to define, in detail, the statistical aspects of
the trial design, the process of data selection for all analyses, the data items to
be analyzed, all the procedures and methods to be employed in the analysis of those
data items, and the planned presentation of those results in formats such as tables,
listings and figures (TLFs). Includes plan for interim and final analysis. [Adapted
from TMF-RM]; CDISC: Documentation describing the statistical aspects of the clinical trial design;
the process of data selection for analyses; the detailed analyses of data items; the
procedures and methods employed for analyzing the data; the planned presentation of
results in formats such as tables, listings, and figures.;
Origin ID : C115761;
UMLS CUI : C3889277;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
