01581nas a2200265   4500000000100000008004100001653001000042653001400052653003900066653001800105100001300123700001400136700001400150700001300164700001200177700001200189700001400201700001400215245011500229856007700344300001000421490000600431520086400437022001401301       2014                            d10aTrial10aTreatment10aNeglected tropical diseases (NTDs)10aClinical data1 aOmollo R1 aOchieng M1 aMutinda B1 aOmollo T1 aOwiti R1 aOkeyo S1 aWasunna M1 aEdwards T00aInnovative approaches to clinical data management in resource limited settings using open-source technologies.  uhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161312/pdf/pntd.0003134.pdf  ae31340 v83 aThe 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.  a1935-2735