EXHIBIT 1.
Course Titles and Objectives
| Research Coordination 1 (RC1) – Overview of Teaching Strategies in Clinical Research (6 weeks) |
| Discuss basic principles and theories of teaching and learning. |
| Apply strategies for assessment of learning needs. |
| Develop learning objectives and prepare an educational program based on an assessment of learning needs. |
| Evaluate strengths and limitations of a variety of teaching strategies. |
| Apply strategies for evaluation of educational programs. |
| Research Coordination 2 (RC2) - Overview of Historical, Ethical, and Cultural Issues in Clinical Research (6 weeks) |
| Analyze historical, cultural, and ethical influences on clinical research. |
| Describe critical components of the informed consent process |
| Discuss good clinical practice guidelines. |
| Discuss issues related to scientific integrity in clinical research |
| Research Coordination 3 (RC3) – Overview of Research Methods and Regulatory Processes in Clinical Research (6 weeks) |
| Identify different types of descriptive and experimental clinical studies. |
| Identify threats to internal and external validity in clinical studies. |
| Analyze strategies that CRMs and investigators can use to minimize threats to internal and external validity in clinical studies. |
| Analyze strategies for regulatory approval of clinical studies. |
| Research Coordination 4 (RC4) - Overview of Clinical Research Site Operations and Management (12 weeks) |
| Differentiate the roles of personnel in a clinical study. |
| Discuss the process for study protocol review and feasibility analyses. |
| Review sponsor criteria for study site selection and monitoring. |
| Develop strategies for recruitment, informed consent and retention of study participants. |
| Analyze the process of ensuring data quality in clinical research |
| Discuss issues in managing a clinical research site. |
| Develop standard operating procedures and protocols for ensuring compliance with ethical guidelines for research and preventing or addressing scientific misconduct and conflicts of interest. |
| Develop and implement a project to enhance team function and leadership in the planning, implementing and evaluating of a clinical trial protocol at the research site. |
| Research Coordination 5 (RC5) – Issues in Clinical Research (6 weeks) |
| Identify and discuss current issues in clinical research |
| Develop individual learning goals and implement project based on these goals. |
| Develop and present formatted annotated bibliographies of literature search findings |
| Discuss issues in clinical research management based on shared findings within the course community. |