This course will be led by Drs. Daniel Masys in collaboration with Drs. Christopher Chepken, andMatthew Dunbar. The focus will be clinical research data management that complies with international Good Clinical Practice (GCP) standards as published by the International Congress on Harmonization, E6 Consolidated Guidance. The course will begin with an overview of the GCP process used internationally for conduct of human subjects research, and how it supports research data management that is accurate, complete, timely, verifiable, secure, and available for analysis. Principles of database design, and use of international controlled vocabulary standards for creation of research variables and their values will be illustrated by hands on experience using REDCap (Research Electronic Data Capture), a freely available, secure web-based data management system adopted by more than 2,500 institutions worldwide. Creation of paper and electronic data capture forms will be taught, along with principles and practice of information security as they apply to sensitive and nonsensitive data. Mobile data collection will be taught with an emphasis on Open Data Kit (ODK) which was developed at the UW Department of Computer Science and Engineering and is free and open source. Methods for compliance with international regulatory requirements, including GCP style independent data audits and other approaches to data validation will be included. Students will create a research data management plan as an independent work assignment, and implement a sample study using REDCap and ODK.

Participating researchers will also complete a "core" course in Creative Integration of ICT Tools and Technologies for Enhancing Research Design and Implementation. This course will consider the state of the art data management tools for ensuring reliable collection, aggregation, back-up, analysis, reporting and archiving of data in useful ways. The course will evaluate health research studies with a focus on studies that successfully (or unsuccessfully) incorporate ICT in resource-limited settings, and teach researchers how to creatively integrate ICT tools and technologies into their health research. The course will also provide suggestions to remain informed of emerging ICT approaches and adapt to future changes in technology. For faculty and staff already familiar with ICT, the course will demonstrate the needs of health researchers and the issues they face in their clinical trials or medical investigations that could be supported by relevant ICT tools. A particular focus will be the use and application of new social technologies, including crowdsourcing and social media for interacting with study populations.

Applications

Applications closed on September 15, 2014. Notification of acceptance or non-acceptance for those pre-selected will be sent by October 15, 2014. For more information, email ICTKenya@uw.edu.