Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Seth Okeyo and Michael Ochieng
Posters-Accepted Abstracts: J Clin Trials
Background: Query management is a key process in data management used in the identification and resolution of data
discrepancies. It directly impacts on data quality and also the integrity of research outcome. At DNDi data center we developed
QMSPlus, a system that enables a simple yet rigorous, structured and semi-automated approach to QM for data managers and
clinical trial managers.”
Methods: QMSPlus is a web-based application which runs on Tomcat Server using Postgres Database Management System.
Once QMS is installed, a study is setup using a simple interface. New users are defined and the necessary query related “csv” files
are uploaded. These include Query Definition file and Query Variable file. When new queries are generated in STATA based on
the edit check program logic, they are exported from STATA in csv format and continually uploaded onto QMSPlus. The Data
Manager prints out data query forms are then sent to the respondents.
Results/Findings: On receiving query responses from the sites, the Data manager updates the QMSPlus with the necessary
corrections and generates a STATA do-file which is executed to apply changes on the dataset extracted from Open Clinica and
clean it. QMSPlus simplifies query Management process and helps generate query report based on different parameters.
Conclusions/Discussion: QMSPlus has greatly impacted data management activities at the DNDi Data Center providing useful
features such as;
• An automated clinical data query management system developed on an open source software platform.
• Allows import and export of data in different formats hence easy to use with diverse data management systems
• It is 100% web-based - a user therefore only needs a computer, a web browser and internet connection to use the software.
• Includes automated query analytics module for query analysis and query report generation