This course provides the student with a solid foundation and understanding of how clinical data contributes to the market application process. Beginning with describing the documents required for regulatory approval of products for marketing, the course will discuss the planning process for data collection, processing, management, analysis, and summarization. Overall consideration in the generation of databases and analyses of data will be explored. Key statistical principles and tools will be applied to clinical trial protocols and statistical analysis plans.
- Evaluate the key components in data collection, management, and processing.
- Examine the key statistical concepts routinely employed in analyzing, summarizing, and interpreting the data generated in the process of clinical research.
- Distinguish clinical trial monitoring as a process of preserving data integrity.
- Differentiate between clinical trial protocols, case report forms, statistical analysis plans, clinical study reports, overall development databases, and marketing approval applications.
- Defend the process of critically interpreting published medical literature.
- Formulate the development of a sound scientific and statistical approach to creation of a clinical trial.
Recommended: Prior completion of
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