Course

Mastering Medical Writing: Communicating Scientific Research Effectively

“Unlocking the Power of Pen: Mastering Medical Writing for Impactful Scientific Communication”

About Course:

Aim: This course aims to equip participants with the skills and knowledge necessary for effective medical writing in the context of clinical research. Participants will learn how to write clear, concise, and scientifically accurate documents, such as clinical study protocols, regulatory submissions, research manuscripts, and patient information leaflets.

Course Objectives:

What you will learn?

Week 1: Introduction to Medical Writing in Clinical Research

  • Overview of medical writing and its importance in clinical research
  • Key characteristics and requirements of effective medical writing

Week 2: Scientific Manuscript Writing

  • Structure and components of a scientific manuscript
  • Writing methods and strategies for research articles

Week 3: Regulatory Document Writing

  • Overview of regulatory documents in clinical research (e.g., protocols, investigator brochures)
  • Writing guidelines and best practices for regulatory submissions

Week 4: Clinical Study Report (CSR) Writing

  • Structure, content, and formatting of a clinical study report
  • Reporting of study results, statistical analysis, and interpretation

Week 5: Clinical Trial Protocols and Informed Consent Forms

  • Writing clear and comprehensive clinical trial protocols
  • Informed consent document development and language considerations

Week 6: Patient Information Leaflets and Study Recruitment Materials

  • Writing patient-centered materials for study recruitment and informed consent
  • Simplifying complex medical information for lay audiences

Week 7: Medical Writing for Systematic Reviews and Meta-Analyses

  • Writing systematic review protocols and reports
  • Conducting literature searches, data extraction, and analysis

Week 8: Poster and Abstract Writing

  • Effective communication of research findings through posters and abstracts
  • Structuring content, selecting visuals, and conveying key messages

Week 9: Medical Writing for Regulatory Submissions

  • Writing clinical summaries and overviews for regulatory submissions
  • Compliance with Common Technical Document (CTD) format and requirements

Week 10: Medical Writing for Medical Devices and Pharmacovigilance

  • Documentation requirements for medical device research and vigilance reports
  • Writing adverse event reports and safety narratives

Week 11: Publication Ethics and Authorship Guidelines

  • Understanding publication ethics and responsible authorship
  • Avoiding plagiarism, conflicts of interest, and ethical considerations

Week 12: Medical Writing Future Trends and Closing Remarks

  • Emerging trends in medical writing and technological advancements
  • Recapitulation of key concepts and closing remarks

Fee Plan

INR 1999 /- OR USD 50

Intended For : Graduates, Post Graduates, Research Scholars, Academicians, Industry Professionals of Medical, Biotechnology and Pharmaceutical Industry

Career Supporting Skills

A

Course Outcomes

  • Proficiency in medical writing principles and best practices in clinical research.
  • Skills in writing clinical study protocols, informed consent forms, and regulatory submissions.
  • Competence in writing research manuscripts, abstracts, and scientific presentations.
  • Knowledge of ethical considerations and plagiarism prevention in medical writing.
  • Ability to communicate scientific research effectively through written documents.