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.

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The main goal of this course is to increase participants’ skill in substantive editing—that is, editing that moves beyond mechanics to address aspects such as content, logic, and organization. 

Topics will include:

• Definitions and components of substantive editing.
• Structures of common types of medical articles.
• Standard guidelines for articles reporting major types of medical research.
• The author-editor relationship.

The course also will provide an overview of publication ethics, especially as related to medical editing. Course activities will include editing exercises, case discussions, and conversations with substantive editors and others. In addition, participants will explore resources useful in continuing to learn about substantive editing, publication ethics, and related subjects.

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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.

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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.

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Not currently available.

In this course, students will 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. Assignments will focus on the complete and proper reporting of research activities, data, and statistical analyses, in keeping with the need to support the practice of evidence-based medicine. 

The following topics will be covered: 

• Variables and descriptive statistics
• Hypothesis testing and P values
• Estimates and confidence intervals
• Measures of risk tests of association
• Measures of correlation
• Simple and multiple linear and logistic regression analyses
• Diagnostic testing
• Randomized trial

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Not currently available.

This course is designed to introduce regulatory writing as both a broad and specific skill set. Students will work to develop the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. For the purposes of this course, the regulatory packet includes the protocol and its amendments, the Investigator's Brochure, informed consent forms, and other submissions to regulatory and oversight bodies such as the IRB and IBC.

Through the completion of this course, students will learn how to:

• Navigate and respond to the current regulatory environment of biomedicine from pharma and devices to innovative cellular therapies.
• Identify and edit an array of regulatory documents and submissions.
• Collaborate with a team on the roles of legal justification and rationale.
• Begin to tailor their regulatory writing to meet specific audience requirements.

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Writing for Patient Education offers an overview of patient communications and provides 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.

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Healthcare advertising is a multi-billion-dollar industry. Promotional medical writers play an integral role in the conceptualization and development of digital and printed healthcare marketing material. This course takes learners behind the scenes of healthcare advertising to understand how the industry works and how to develop compelling advertising copy against the backdrop of a highly regulated advertising environment. Students will apply the principles of promotional medical writing (i.e., medical copywriting) through several small assignments and the production of a piece of marketing material (speculative work) for use in their portfolios.

Available Sections:

No current courses being offered.

This course is designed to introduce regulatory writing as both a broad and specific skill set. Students will work to develop the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. For the purposes of this course, the regulatory packet includes the protocol and its amendments, the Investigator's Brochure, informed consent forms, and other submissions to regulatory and oversight bodies such as the IRB and IBC.

Students will learn how to:

• Navigate and respond to the current regulatory environment of biomedicine from pharma and devices to innovative cellular therapies.
• Identify and edit an array of regulatory documents and submissions.
• Collaborate with a team on the roles of legal justification and rationale.
• Begin to tailor their regulatory writing to meet specific audience requirements.

Available Sections:

This advanced course will cover FDA submissions as well as regulatory writing and documents associated with the major clinical trial milestones, responding to regulatory review, and writing about regulations. Students will learn the intricacies of FDA device, drug, and biologic submissions, gain knowledge and familiarity with the preparation and submission of specific FDA documents and correspondence in accordance with requirements and best practices, further understand the regulatory writing components of clinical trials from start up to close out, and begin to think about regulatory documents from a reviewer’s perspective and practice drafting responses.

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