A Pragmatic Method to Integrate Data From Preexisting Cohort Studies Using the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model: Case Study.

ABSTRACT:

Background

In recent years, many researchers have focused on the use of legacy data, such as pooled analyses that collect and reanalyze data from multiple studies. However, the methodology for the integration of preexisting databases whose data were collected for different purposes has not been established. Previously, we developed a tool to efficiently generate Study Data Tabulation Model (SDTM) data from hypothetical clinical trial data using the Clinical Data Interchange Standards Consortium (CDISC) SDTM.

Objective

This study aimed to design a practical model for integrating preexisting databases using the CDISC SDTM.

Methods

Data integration was performed in three phases: (1) the confirmation of the variables, (2) SDTM mapping, and (3) the generation of the SDTM d

SUBMITTER: Matsuzaki K 

PROVIDER: S-EPMC10766166 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature