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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?

  1. Identify different clinical trial documents and their role in the clinical trial process
  2. Describe the elements of a protocol including the hypothesis, objectives, endpoints, and inclusion/exclusion criteria, as well as its corresponding CRF.
  3. Recognize key regulatory requirements for clinical study reports and understand their format, structure, and relationship to the study protocol
  4. Understand the background of CTD submissions worldwide and the basics of correct CTD format and requirements
  5. Acquiring the ability to report advisory board meeting minutes and the proficiency in preparing posters and presentations
  6. Developing basic questionnaire and survey development skills