Course Description

The Clinical Research Associate (CRA) creates reports that have many audiences, one being regulatory authorities reviewing essential documentation of clinical trials linked to marketing application approvals. This web seminar presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, Memos to File, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective, and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.

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Learning Objectives

• Examine the impact of poor report writing
• Apply the definitions and concepts of scientific report writing
• Implement the 10 rules of quality report writing for CRAs
• Apply the 10 rules to CRA activities
• Write action items, deviations, queries
• Integrate essential document mapping within a monitoring report
• Describe the challenges of CRA report writing and report review

Who Should Attend

• Clinical Research Associates
• Contract Clinical Research Associates
• Clinical Research Associate Managers
• Project Managers

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.