10x10 with OSU: Course Description

This survey course provides a broad overview of the field, highlighting the key opportunities and challenges for the field. The course is taught in a completely asynchronous manner, i.e., there are no "scheduled" classes. However, students must keep up with the course materials so they can benefit from the interactive discussion with faculty and other students.

The course uses the following teaching modalities:

• Voice-over-Powerpoint lectures - The key material is delivered via the internet using the Flash plug-in, which is freely available and already installed in almost all Web browsers.
• Interactive threaded discussion - Students will engage in discussion on issues related to each week's course using the on-line bulletin board. An on-line faculty moderator helps keep the discussion on track.
• Reading assignments - Because of the new and rapidly evolving nature of this domain, there is as yet no textbook adequate to cover the topic. As such, the course will use a combination of resources derived from texts, peer-reviewed literature, reports, documents, and a variety of key web-based resources from the field as appropriate to cover each week's topic area.
• Homework/quizzes - Each of the 10 weekly units will be accompanied by a 10-question multiple-choice self-assessment that aims to have the student apply the knowledge from the unit.

The on-line part of the course is accessed via the Blackboard course delivery tool. At the onset of the course, each student is provided a login and password by the Department of Biomedical Informatics staff to access the course online. All assigned readings are either freely available on-line or provided by OSU. Students will be expected to spend 4-8 hours per week on the course (2-3 hours of lecture plus 2-5 hours of independent work/interaction with colleagues in preparation for and following the lecture).

The in-person component aims to bring students, faculty experts, and the materials together for an intensive in-person session. The program for the in-person session will consist of a half-day session offered during the AMIA 2013 Joint Summits on Translational Science (March 18-22, 2013 in San Francisco, CA). The date of the in-person session is still to be determined. The in-person session will involve lectures and interaction with key leaders active in the major initiatives helping to drive the CRI domain forward and about which the students will have learned in the preceding online- components of the course (e.g. CTSA, caBIG, BRIDG, CDISC, etc.). Students will also be required to complete a short course project related to a practical CRI-related undertaking relevant to their particular environment. At the in-person session, they will present their assessment to their fellow students and faculty, gaining new insights into the required elements for such an undertaking.

Class Outline

The following outlines the class titles for the program.

1. Course Overview & general Biomedical Informatics Principles
2. Overview of Clinical Research
3. Informatics Applications in Clinical Research (Part 1)
4. Informatics applications to Clinical and Translational Research (Part 2)
5. Research, Data Collection, Management and Analysis
6. Enterprise Systems in CRI
7. Data and Knowledge Standards in CRI
8. Regulatory and Ethical Issues in CRI
9. Translational Research Informatics, and CRI-BMI overlaps
10. Review major CRI Initiatives and future directions

The on-line portion of the course will run from January 7th to March 15, 2013.  The in-person session will take place at the AMIA 2013 Joint Summits on Translational Science (March 18-22, 2013, San Francisco, CA).

Readings

Reading assignments consist of freely available articles, reports, documents, web-based resources, and other readings. Students are responsible for learning all content in the readings, whether discussed in the lectures or not.

Competencies

The Ohio State University 10x10 offering has the following learning objectives:

• Explain basic principles of biomedical and health informatics including health system architectures, evaluation, etc.
• Define biomedical informatics and the clinical research informatics subdomain of biomedical informatics.
• Identify the major challenges and opportunities facing the CRI domain.
• Identity the basic principles of clinical research including the research process, aspects of study design, data collection and analysis, etc.
• Identify the application of research-specific informatics approaches and tools in clinical research.
• Explain informatics methods and tools applied to research hypothesis development.
• Explain informatics methods and tools applied to protocol development, patient recruitment, data analysis and reporting, dissemination and utilization of research findings, adverse event surveillance, and pharmacovigilance.
• Describe best practices and principles for data collection, management and reporting.
• Explain principles and practices of research database and data warehouse development.
• Identify the key elements and features of clinical trial management and electronic data capture systems.
• Explain the importance of standards, terminologies, and models in biomedical informatics.
• Understand ontology and model initiatives in CRI.
• Identify key issues in privacy, confidentiality and research oversight relevant to CRI practice
• Identify key ethical considerations in research informatics, trial registration, and results dissemination.
• Understand the overlap of Clinical Research Informatics and related domains of Clinical Informatics, Translational Bioinformatics, and Public Health Informatics.
• Describe major national and international initiatives driving the CRI Agenda
• Explain key CRI directions for the future.

Lead Instructor

The lead instructor for the course is Peter J. Embi, MD, MS.

Additional instructor for the OSU 10x10 course include:

Philip R. O. Payne, PhD, The Ohio State University

More information about the course instructors can be found at The Ohio State University's Department of Biomedical Informatics Website.