Course Description
The program will help clinical data managers with a standard
of knowledge, education and experience by which they would be officially
recognized.
Who is the target audience?
Data managers, healthcare professionals
What am I going to get from this course?
- Identify different clinical trial documents and their role in the clinical trial process
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Describe the elements of a protocol including the hypothesis, objectives, endpoints, and inclusion/exclusion criteria, as well as its corresponding CRF.
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Recognize key regulatory requirements for clinical study reports and understand their format, structure, and relationship to the study protocol
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Understand the background of CTD submissions worldwide and the basics of correct CTD format and requirements
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Acquiring the ability to report advisory board meeting minutes and the proficiency in preparing posters and presentations
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Developing basic questionnaire and survey development skills
