Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

ABSTRACT:

Background

Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented.

Methods

A generic database mo

SUBMITTER: Zhao W 

PROVIDER: S-EPMC4785064 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature