ODM Data Analysis-A tool for the automatic validation, monitoring and generation of generic descriptive statistics of patient data.

ABSTRACT:

Introduction

A required step for presenting results of clinical studies is the declaration of participants demographic and baseline characteristics as claimed by the FDAAA 801. The common workflow to accomplish this task is to export the clinical data from the used electronic data capture system and import it into statistical software like SAS software or IBM SPSS. This software requires trained users, who have to implement the analysis individually for each item. These expenditures may become an obstacle for small studies. Objective of this work is to design, implement and evaluate an open source application, called ODM Data Analysis, for the semi-automatic analysis of clinical study data.

Methods

The system requires clinical data in the CDISC Operational Data Model format.

SUBMITTER: Brix TJ 

PROVIDER: S-EPMC6014674 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature