Innovative approaches to clinical data management in resource limited settings using open-source technologies.

The primary objective of clinical data management (CDM) is to provide high-quality, reliable data for reporting randomized controlled trials (RCTs) in line with good clinical practice (GCP) requirements. For treatment trials of neglected tropical diseases (NTDs) in endemic countries, CDM systems need to be efficient and affordable. Challenges include poor infrastructure, license costs associated with GCP-compliant software, and limited human resources to provide the required expertise. We argue that high-quality CDM for NTDs can be achieved and that challenges can be overcome through the use of readily available open-access tools. We describe our development of two new tools for CDM: an offline module for OpenClinica users and a query management system (QMS) that allows automation and standardization of query management with multiple-user access.