Curriculum

In this overview of medical copyediting, you will examine the mechanics of language and usage as well as editing concepts specific to medical manuscripts. Using the American Medical Association Manual of Style and its online resources, students gain hands-on experience editing general medical materials.

Topics covered include:

• The role of a copy editor
• Correct grammar, punctuation, capitalization, and usage
• An introduction to medical nomenclature

This overview of substantive editing—editing that moves beyond mechanics to address content, logic, and organization—includes structures of common types of medical articles, standard guidelines for articles reporting major types of medical research, the author—editor relationship, and publication ethics. The practicum will include editing exercises, case discussions, and conversations with substantive editors and others.

What is ethical—and what is not—in medical writing and editing? While the medical editor or writer may not have ultimate responsibility for a published article or other work, they are responsible for understanding such issues as authorship, acknowledgement, financial disclosures, conflicts of interest, "salami science," and how to flag ethical concerns and talk about them with authors or supervisors.

This course aims to produce medical editors and writers who have reviewed the fundamentals of writing and research ethics and are attuned to "flag" them with peers and other stakeholders when they arise in daily practice. Students are not expected to exit the course with a clear answer to every ethical question in writing and research, but to know where to seek answers, how to raise questions about ethical issues, and how to participate in the ongoing discussion about ethics in medical research and publication. 

At the end of this course, you should be more prepared to trust the instincts that compel you to ask questions and have a framework for reviewing, understanding, and problem-solving ethical concerns in medical writing and editing.

This course is designed to give you the foundation you need to create effective and accurate tables, graphs, and figures. Students will learn their general structure, how to choose among them, and the guidelines for choosing what graphing format to use.

Learn how to interpret and report the most common statistical tests and procedures used in biomedical and epidemiological research. Lectures and readings will address basic statistical concepts and reasoning, the characteristics of various types of analyses, and how to assess the design and statistical aspects of scientific research. In keeping with the need to support the practice of evidence-based medicine, assignments will focus on the complete and proper reporting of research activities, data, and statistical analyses.

This course, designed to introduce regulatory writing as both a broad and specific skill set, teaches the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. Learn to navigate and respond to the current regulatory environment of biomedicine, identify and edit an array of regulatory documents and submissions, collaborate with a team on the roles of legal justification and rationale, and begin to tailor your regulatory writing to meet specific audience requirements.

Writing for Patient Education will offer an overview of patient communications and provide learners with a framework for creating materials that patients, families, and caregivers can use. It will address the difference between need-to-know and nice-to-know information, explore the various formats of patient information, evaluate real-world examples, and engage students in rewriting existing samples and creating their own samples to start building a work portfolio.

This course, designed to introduce regulatory writing as both a broad and specific skill set, teaches the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. Learn to navigate and respond to the current regulatory environment of biomedicine, identify and edit an array of regulatory documents and submissions, collaborate with a team on the roles of legal justification and rationale, and begin to tailor your regulatory writing to meet specific audience requirements.

This advanced course will cover FDA submissions, regulatory writing, supportive documentation for major clinical trial milestones, how to respond to regulatory review, and write about regulations. Students will learn the intricacies of FDA device, drug, and biologic submissions, and gain familiarity with the preparation and submission of required regulatory documents.