Medical Writing Course

Lesson 1 • Core Document Types

Surveys the primary documents medical writers produce, from clinical reports to patient materials. Provides context for all subsequent chapter-specific writing instruction.

Lesson 2 • Ethics and Professional Standards

Covers authorship criteria, disclosure obligations, and data integrity requirements. Grounds students in the ethical framework governing all medical writing practice.

Lesson 3 • Regulatory and Style Frameworks

Introduces international regulatory guidance and major style guides used in medical writing. Students learn which framework applies to each document type.

Lesson 1 • Paragraph and Document Coherence

Teaches topic sentences, transitional logic, and paragraph-level organization. Students learn to build arguments that flow from sentence to section level.

Lesson 2 • Editing for Precision and Tone

Introduces self-editing techniques to eliminate ambiguity, hedging, and inappropriate tone. Prepares students to review their own drafts critically before submission.

Lesson 3 • Numbers, Units, and Data Presentation

Establishes rules for reporting numerical data, units of measure, and statistical values in text. Ensures consistency and accuracy across all document types.

Lesson 4 • Medical Terminology Mastery

Builds accurate use of anatomical, pharmacological, and clinical terminology. Prevents terminology errors that undermine document credibility.

Lesson 1 • Biostatistics for Medical Writers

Explains descriptive statistics, hypothesis testing, and common analytical methods without requiring advanced math. Enables accurate interpretation of results sections.

Lesson 2 • Reading and Interpreting Study Reports

Trains students to extract key findings from clinical study reports and statistical analysis plans. Builds the critical reading skills underlying accurate document drafting.

Lesson 3 • Translating Data into Written Summaries

Applies data interpretation skills to drafting accurate, balanced results narratives. Students practice converting tables and figures into coherent prose.

Lesson 1 • Regulatory Submission Overview

Maps the structure of a marketing authorization dossier and the writer's role within it. Contextualizes all subsequent regulatory document instruction.

Lesson 2 • Summary Documents and Overviews

Addresses the writing of integrated summaries of safety and efficacy within a submission dossier. Students synthesize data across multiple studies into cohesive narratives.

Lesson 3 • Clinical Study Report Writing

Teaches the internationally harmonized structure and required content of clinical study reports. Students draft key sections including synopsis, methods, and results.

Lesson 4 • Investigator Brochure Development

Covers the purpose, structure, and update cycle of the investigator brochure for clinical trials. Students learn to balance scientific detail with practical usability.

Lesson 1 • Critical Appraisal of Evidence

Introduces tools for assessing study quality, bias risk, and evidence hierarchy. Students evaluate sources before incorporating them into written documents.

Lesson 2 • Meta-Analysis Interpretation and Reporting

Covers how to interpret and accurately report meta-analytic results without conducting the analysis. Students describe pooled estimates, heterogeneity, and sensitivity analyses in text.

Lesson 3 • Systematic Search Strategies

Teaches database selection, Boolean logic, and PICO framework for reproducible literature searches. Provides the methodological foundation for all evidence synthesis tasks.

Lesson 1 • Anatomy of a Research Manuscript

Breaks down the IMRAD structure and the purpose of each manuscript section. Establishes the organizational framework students apply throughout this chapter.

Lesson 2 • Presenting Results Effectively

Covers text-based results reporting, table construction, and figure design for manuscripts. Students learn to present data without interpretation in the results section.

Lesson 3 • Writing the Introduction and Methods

Teaches how to frame research rationale and describe methodology with reproducible precision. Students draft introduction and methods sections for a sample study.

Lesson 4 • Abstracts and Reporting Guidelines

Covers structured and unstructured abstract formats and major reporting checklists for clinical research. Students apply the appropriate checklist to their draft manuscript.

Lesson 1 • Informed Consent Document Writing

Covers the required elements and plain language standards for clinical trial informed consent forms. Students draft a consent form section meeting readability and regulatory requirements.

Lesson 2 • Digital and Social Health Content

Addresses writing for health websites, apps, and social media within accuracy and compliance constraints. Students adapt a clinical summary into a digital patient-facing format.

Lesson 3 • Health Literacy Principles

Defines health literacy levels and their impact on patient comprehension and outcomes. Establishes the audience-centered mindset required for all patient-facing writing.

Lesson 1 • Document Review and Quality Processes

Teaches structured review cycles, annotation practices, and quality checklists for medical documents. Students conduct a mock review of a draft clinical document.

Lesson 2 • Building a Medical Writing Portfolio

Guides students in selecting, presenting, and contextualizing writing samples for professional portfolios. Prepares graduates to demonstrate competency to employers and clients.

Lesson 3 • Project Planning for Medical Writers

Covers scope definition, timeline development, and resource planning for complex writing projects. Students build a project plan for a multi-document regulatory submission.

Lesson 4 • Strategic Communication with Subject Experts

Develops skills for extracting accurate content from clinicians, statisticians, and scientists. Students practice structured interviews and content validation techniques.