Jun 10, 2023
CRC 230 - Clinical Research Design 3 Credits, 3 Contact Hours
3 lecture periods 0 lab periods
Introduction to the scientific concepts related to the design and analysis of clinical trials. Includes key elements of a clinical trial protocol, from hypothesis, trial development, to trial feasibility and analysis. Also includes ethical and human subject protection considerations relative to research protocol and trial execution.
Recommendation: Completion of or concurrent enrollment in CRC 101 . If any recommended course is taken, see a financial aid or Veteran’s Affairs advisor to determine funding eligibility as appropriate.
Course Learning Outcomes
- Explain the basic and complex types of research methods and how they relate to clinical trial design.
- Apply ethical principles of research to clinical trial protocols and data collection procedures.
- Describe how statistics and informatics relate to trial objectives, data analysis, and interpretation.
- Discuss the evaluation and interpretation of clinical trials results.
- Explore elements to present research findings.
- Identify Study Question, Objectives, and Procedures
- Select an Optimal Study Approach to answer the Study Question.
- Design the trial and create a data collection plan.
- Discuss elements of Data Analysis
- Communicate research findings.
- Scientific Approach Applied to Development of Research Protocol
- Overall process of clinical research development
- General Principles of investigational product regulation
- Development of appropriate research hypothesis specific to each phase of protocol development
- Selecting a Research Question
- Reviewing the Literature
- Defining Study-Specific Aims
- Background information including a synopsis of the properties of the investigational product
- Study objectives and purpose
- Study goals and endpoints
- Selection of subject and precedent for subject withdrawal
- Selecting a Study Approach
- Overview of research designs
- Case Studies
- Cross-Sectional Studies
- Case-Control Studies
- Cohort Studies
- Experimental Studies
- Qualitative Studies
- Correlational Studies
- Synthesis Research
- Designing the Study and Data Collection
- Research Protocols
- Ethical Considerations
- Ethical Review and Approval
- Population Sampling, Sample Size, and Power
- Collecting Quantitative and Qualitative Data
- Developing Questionnaires and Assessments
- Analyzing Data
- Data Management
- Descriptive and Comparative Statistics
- Regression Analysis
- Qualitative Analysis
- Additional Analysis Tools
- Reporting the Findings
- Posters and Presentations
- Article Structure
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