Preferred Label : Statistical Analysis Plan;
NCIt related terms : SAP; StatisticalAnalysisPlanVersion; SA Plan;
NCIt definition : A proposed method to describe and define the following: the statistical aspects of
a 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 (LTEs).;
Alternative definition : CDISC-GLOSS: A document that contains a more technical and detailed elaboration of
the principal features of the analysis described in the protocol, and includes detailed
procedures for executing the statistical analysis of the primary and secondary variables
and other data. [ICH E9]; 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]; BRIDG 5.3: A point-in-time snapshot of a statistical analysis plan. EXAMPLE(S): OTHER
NAME(S): NOTE(S): The statistical analysis plan evolves during the course of the study
and accordingly the snapshot may address a different issue at varying levels of detail
relative to the final plan.;
Origin ID : C115761;
UMLS CUI : C3889277;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
