This course will provide the student with the necessary background for preparing verbal and written communications for the clinical affairs function within a biomedical organization. Beginning with an understanding of the documents required for regulatory approval of products for marketing, the course will identify and discuss the planning process for data collection, processing, management, analysis, and summarization. Overall considerations in generation of clinical trial protocols, regulatory communications, and final clinical reports will be covered.
- Evaluate the key stakeholders in the biomedical organization and clinical affairs function in particular.
- Contrast the key communication concepts, links, and methods routinely employed in clinical research.
- Select the key communication instruments and tools of clinical affairs.
- Design clinical trial plans and protocols, case report forms, clinical study reports, and the respective clinical research approval documents.
- Defend the value of critically communicating clinical research information.
- Formulate a sound scientific and strategic approach to communicating clinical results.
Recommended: Prior completion of
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