This free online course focused on clinical research data management that complies with international Good Clinical Practice (GCP) standards as published by the International Congress on Harmonization, E6 Consolidated Guidance.
This course is offered in a self-managed fashion and you will have the opportunity to interact with other students in your cohort but there will not be a live faculty component. The course material was developed by Dr. Daniel Masys in conjunction with Christopher Chepken.
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.
This online course is supported by the Fogarty International Center. You can read more the project overview here.
You can apply for this course using the following link https://edgh.washington.edu/project/fogarty-kenya-ict/course-application