We at the CHI have entered into a partnership with the American Medical Informatics Association (AMIA) to offer a first-of-its-kind program focused on the emerging biomedical informatics sub-domain of clinical research informatics.
This course will be offered via distance learning and will provide students with an overview of the field of clinical research informatics. Through this offering, the University of Cincinnati becomes the fifth University to partner with AMIA in its 10x10 program - a program with the goal of providing 10,000 professionals with training in biomedical informatics by 2010.
About the course
The UC 10x10 program is an intensive course that provides students with a survey of the rapidly emerging field of clinical research informatics. In addition to defining the CRI domain and highlighting the key challenges and opportunities facing CRI, students will be exposed to key models, approaches, tools, regulatory/ethical issues and initiatives driving CRI developments and practice. The course will also provide students with an understanding of the relationships that exist between CRI and the clinical informatics and bioinformatics domains. While no prerequisite course requirements will be strictly enforced for matriculation into the course, completion of CITI or equivalent training in research ethics, protection of research subjects and/or good clinical practice within the last 2 years is highly recommended as a basis for understanding clinical research ethical and regulatory principles that will be alluded to in the course but not explicitly covered.
Objectives
The 10x10 program was started when former American Medical Informatics Association (AMIA) President Dr. Charles Safran asserted that the United States needs one physician and one nurse trained in medical informatics in each of the 6,000 hospitals in the United States.
The 10x10 program aims to provide introductory training to build the workforce that will enable information technology to improve the quality, safety, and cost-effectiveness of health care. Since the program was launched in 2005, nearly 600 people have completed the course, some going on to advanced study in the field.
The goal of the AMIA-UC 10x10 course is to provide students with a survey of the rapidly emerging field of clinical research informatics. The course will define the CRI domain and highlight key challenges and opportunities facing CRI. It will provide students with an understanding of the relationships that exist between CRI and the clinical informatics and bioinformatics domains.
Course Logistics
The course is offered in two parts:
1. A 10-unit Web-based component starting February 9, 2009. The Web-based portion is provided through readings, lectures, interactive discussion, and self-assessment tests.
2. An intensive one-day in-person session held in conjunction with the AMIA 2009 Spring Congress (Orlando, FL; May 28-30, 2009). This session will take place the day before the meeting, on May 27, 2009 from 8 am - 12 pm. The in-person session will bring attendees together to integrate the material, allow presentation of course projects, and meet leaders in the field as well as other students.
Registration
Prospective students can register for the course on the AMIA Website.
The registration deadline for the course is February 9th, 2009. We will accept enrollees after that date on a space-available basis.
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 Center for Health Informatics staff to access the course online. All assigned readings are either freely available on-line or provided by UC. 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 tutorial offered during the AMIA Annual Symposium and the AMIA Spring Congress (to be attended by students completing the course prior to either meeting). Following the tutorial, 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.
- Course Overview & general Biomedical Informatics Principles
- Overview of Clinical Research
- Informatics Applications in Clinical Research (Part 1)
- Informatics applications to Clinical and Translational Research (Part 2)
- Research, Data Collection, Management and Analysis
- Enterprise Systems in CRI
- Data and Knowledge Standards in CRI
- Regulatory and Ethical Issues in CRI
- Translational Research Informatics, and CRI-BMI overlaps
- Review major CRI Initiatives and future directions
The on-line portion of the course will run from early February to late May, 2009. The in-person session will take place at the 2009 AMIA Spring Congress (May 27-30, 2009, Orlando, FL).
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
Our University of Cincinnati 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.
