BMED 2400 - Introduction to Clinical Research

1. Describe the role of the clinical research professional and relationship to the research team.
2. Identify assumptions, characteristics and aims of the scientific approach.
3. Explain the steps in the research process.
4. Compare and contrast types of research.
5. Formulate a research question/hypothesis.
6. Select a research design appropriate for a proposed study.
7. Identify ethical issues associated with each step in a clinical study.
8. Formulate a human subjects protocol and an informed consent form that protect the rights of human subjects.
9. Describe the principles of subject recruitment and retention.
10. Develop questionnaires appropriate for the clinical study, including informed consent, medical questionnaire and adverse events report.
11. Develop a timeline and budget for a clinical study.
12. Identify appropriate tools to measure dependent and independent variables.
13. Describe the process for data collection and documentation.
14. Describe the clinical trial auditing process and associated role of the clinical researcher.
15. Describe the application of computer programs in data management and analysis.
16. Formulate a plan for monitoring the progress and terminating a clinical study.
17. Demonstrate understanding of principles involved in a post-marketing study.
18. Describe various methods of communicating research findings.
19. Explain the significance of applying research findings to the health care industry.

1. Role of the clinical research professional
2. Steps in the research process
3. Ethical issues in conducting clinical research
4. Types of research
5. Literature review
6. Formulating research hypothesis
7. Defining variables
8. Research design
9. Timeline
10. Budget
11. Population and sample
12. Selecting investigators and study sites
13. Developing questionnaires
14. Measurement tools
15. Data collection and documentation
16. Clinical trial auditing
17. Data analysis
18. Monitoring and terminating clinical study
19. Post-marketing studies
20. Research report
21. Application of research findings