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Regulatory and Academic Medical Writing

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Regulatory and Academic Medical Writing Courses

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THE WRITOLOGIST
  • bestseller
  • 19 Courses
  • 84 Students
  • All Levels

Medical writing involves writing scientific documents of different types which include regulatory and research-related docume..

  • 500
  • (5)
  • (5 ratings)
What you will learn
  • Introduction and Overview An overview of the workshop program
  • What is Medical Writing? Overview of the research process, why do we write? Types of medical writing, types of scientif...
  • Overview of a Scientific Paper Purpose of a scientific paper, overview of its structure and organization, the general g...
  • Before You Begin Writing What editors, peers, and reviewers are looking for in a paper before discussing how to write a...
  • Manuscript Sections: The Introduction How to craft an effective introduction section for a specific journal and your ta...
  • Manuscript Sections: The Methods The purpose of the methods section, and the five components (study design and setting,...
  • Manuscript Sections: The Tables & Figures This section of the webinar will highlight important considerations when disp...
  • Manuscript Sections: Results This section highlights ways to explain results effectively, focusing on strategic structu...
  • Manuscript Sections: The Discussion This section discusses the basic elements of the discussion, what should a discussi...
  • Manuscript Sections: The Conclusion In this section we will discuss the purpose of the conclusion section and how to st...
  • Manuscript Sections: The Abstract Components and general guidelines for the abstract write-up
  • Manuscript Sections: Title Page, Keywords, Acknowledgements Elements of a title page, the different styles of titles, c...
  • Manuscript Sections: References Citing the literature, formats for citing references, endnote citation manager program
  • Final Review and Pre-submission strategies Usefulness of pre-submission enquiries when deciding which journal to submit...
  • Write-up of different documents Cover letters, Consent Forms, Conflict of Interest Disclosures
  •  Clinical trial protocol function, description, structure and, regulatory requirements
  • Describe the requirements for and elements of a protocol including the hypothesis, clear and concise objectives, primary...
  • Describe adverse events and serious adverse events and their reporting, depending on type of study and type of intervent...
  • Develop a basic statistical understanding (e.g., qualitative and quantitative data, sample size determination, and inter...
  • Develop protocol amendments: how and when to do it and documentation needed
  • Difference between the clinical trial protocol and the clinical study report
  • Content of a clinical study report
  • Documents I read before writing the clinical study report
  • Tips and Tricks for the clinical study report writing process
  • Informed Consent wriy
  • Investigator brochure
  • Overall revision and wrap up