Medical, Regulatory & Scientific Writing Certification

Course Notes
Introduction
Medical writing is a specialized discipline that combines science, communication, and
compliance. It involves producing well-structured documents to communicate clinical and
scientific information clearly and accurately. This eBook is designed as a structured training
manual for freshers—particularly B.Pharm or life science graduates in India—looking to enter
the field professionally.

Module 1: Basics of Medical Writing

Medical writing begins with strong fundamentals in writing quality, structure, and scientific
terminology.
Core Principles
• Clarity: Avoid ambiguity. Every sentence should have a direct and specific meaning.
• Conciseness: Say more using fewer words—no redundancy or filler.
• Accuracy: Scientific facts and figures must be verified against references.
• Consistency: Terms like "hypertension" or "blood pressure" should not be alternated
without reason.
Types of Medical Writing
1. Regulatory Writing: Documents submitted to drug regulatory agencies (e.g., CSRs,
SmPCs).
2. Publication Writing: Peer-reviewed articles, case reports, and scientific posters.
3. Marketing Writing: Lay-friendly content for product promotion (e.g., brochures,
website articles).
Understanding Medical Terminology
Medical words are structured from:
• Roots (e.g., cardi- for heart)
• Prefixes (e.g., hyper- means high)
• Suffixes (e.g., -itis for inflammation)
A strong grasp of terminology helps simplify complex content and interpret clinical findings
accurately.
Fundamentals of Medical Writing
1.1 Definition & Purpose
Medical writing is about translating complex clinical and scientific data into clear, accurate
documents. These may serve scientific, regulatory, educational, or promotional purposes.
Medical writers are key communicators between researchers, healthcare professionals, and
regulatory bodies.
1.2 Types of Medical Writing
• Regulatory Writing: Focuses on documentation required for drug approvals, such as
Clinical Study Reports (CSRs), Investigator Brochures (IBs), and Clinical Trial
Protocols.
• Publication Writing: Includes manuscripts for journals, case reports, conference
posters, and abstracts.
• Medical Marketing Writing: Involves promotional and educational materials for
healthcare professionals (HCPs) and patients.
• Educational Content Development: Includes training modules, Continuing Medical
Education (CME) programs.
• Health Journalism and Blogging: Writing for online platforms, newspapers,
magazines for public health education.
1.3 Core Principles
• Clarity: Avoid ambiguous language. Example: Instead of “patients showed
improvement,” say “65% of patients had a 20-point reduction in blood pressure.”
• Accuracy: Back every claim with data. Use primary sources such as peer-reviewed
journals or clinical trial registries.
• Consistency: Ensure consistent use of terminology (e.g., drug names, dosage units).
Create style guides or follow organizational templates.
• Objectivity: Avoid emotional language or unsupported claims. Let the data speak for
itself.
1.4 Understanding Medical Terminology
• Medical roots: e.g., "cardio" = heart, "neuro" = nerve, "hepato" = liver.
• Prefixes/suffixes: e.g., "-itis" = inflammation (e.g., arthritis), "-ectomy" = surgical
removal (e.g., appendectomy).
• Tools: Use dictionaries like Stedman’s or Dorland’s, or online platforms like
MedlinePlus.
1.5 The Role of a Medical Writer
• Data gathering and literature review
 • Collaboration with clinical research teams
• Drafting, reviewing, and finalizing documents
• Understanding the target audience
• Working within timelines and regulatory frameworks
1.6 Common Mistakes to Avoid
• Plagiarism: Always paraphrase and cite sources.
• Overuse of jargon: Use plain language unless necessary.
• Factual errors: Misreporting data can lead to regulatory rejection.
• Inconsistent tense or voice: Prefer active voice unless passive is standard (e.g.,
regulatory writing).
Module 2: Regulatory Medical Writing
This module covers documents essential for clinical trial execution and drug approval.

Key Documents
1. Clinical Trial Protocol (CTP): Blueprint of the study—includes design, eligibility
criteria, and endpoints.
2. Investigator’s Brochure (IB): Compiles preclinical and clinical data about the drug
for the research team.
3. Clinical Study Report (CSR): Finalized documentation of trial findings submitted to
regulatory bodies.
4. SmPC (Summary of Product Characteristics): Instructional guide for drug use post-
approval.

Regulatory Compliance
Medical writers must follow:
• ICH-GCP: Global standard for ethical clinical trial conduct.
• FDA / EMA / CDSCO: Regional regulatory requirements in the US, Europe, and India,
respectively.
Objective
Ensure all clinical documents are:
• Scientifically sound
• Ethically compliant
• Written in a structured format for regulatory review

Career Opportunities in Medical Writing

2.1 Who Can Become a Medical Writer?
• B.Pharm, M.Pharm, Pharm.D graduates
• M.Sc./Ph.D. in life sciences, microbiology, biotechnology, zoology, biochemistry, etc.
• MBBS, BDS, BHMS, BAMS, or other healthcare-related degrees
2.2 Job Roles & Career Path
• Entry-Level Roles: Medical Writer Trainee, Associate Medical Writer
 • Mid-Level Roles: Medical Writer, Senior Medical Writer
• Advanced Roles: Lead Medical Writer, Principal Medical Writer, Medical Writing
Manager, Freelance Consultant
2.3 Sectors That Hire Medical Writers
• Pharmaceutical companies
• Clinical Research Organizations (CROs)
• Medical communication agencies
• Healthcare IT and publishing companies
• Academic and government research institutions
• Freelance and contract-based platforms
2.4 Skills Needed to Succeed
• Excellent written and verbal communication skills
• Good grasp of scientific and medical concepts
• Research and literature review capabilities
• Familiarity with referencing tools like EndNote, Mendeley
• Time management and adherence to deadlines
2.5 Salary Expectations in India (2025 Estimates)
• Fresher (0–1 year): ₹3 LPA – ₹5 LPA
• 2–3 Years of Experience: ₹5.5 LPA – ₹8 LPA
• Senior Writers (5+ Years): ₹10 LPA – ₹18 LPA
• Freelance: ₹1 – ₹5 per word (depending on complexity, experience, and client location)
2.6 Growth Opportunities
• Transition into scientific publications, regulatory affairs, pharmacovigilance writing
• Project management, team leadership roles
• Teaching, mentoring, or running your own medical writing business or agency
2.7 Where to Find Jobs
• Job Portals: Naukri, Indeed, LinkedIn
• Company Websites: IQVIA, Parexel, Freyr, Novartis, Indegene
• Freelancing Platforms: Upwork, Freelancer, Kolabtree, Fiverr
• Networking: LinkedIn, scientific writing forums, alumni networks
2.8 Resume and Interview Tips
• Highlight writing samples or a personal blog
• Mention scientific and technical software knowledge (e.g., MS Word, EndNote,
PubMed)
• Be ready to take a writing test
• Practice explaining scientific ideas in plain English
Module 3: Publication Medical Writing
Publication writing allows researchers to communicate findings through journals and
conferences.
Standard Guidelines
• AMA (American Medical Association): Covers style and citation for scientific papers.
• ICMJE: Defines authorship criteria, conflict-of-interest disclosure, and clinical trial
registration.
Manuscript Structure (IMRAD)
1. Introduction: Why the study was done.
2. Methods: How it was done.
3. Results: What was found.
4. Discussion: What it means.
Abstract Writing
Crafted last, abstracts must summarize key objectives, results, and conclusions within a strict
word limit.
Publication Lifecycle
• Drafting → Internal Review → Submission → Peer Review → Revisions →
Acceptance
Essential Tools and Software for Medical Writers
3.1 Word Processing and Formatting Tools
• Microsoft Word: Industry standard. Features like track changes, styles, and
referencing are crucial.
• Google Docs: Useful for real-time collaboration. Backup tool when working in teams
remotely.
• LaTeX: Preferred in academic or highly technical publications for precise formatting
of equations, tables, and references.
3.2 Reference Management Software
• EndNote: Allows creation of reference libraries, instant citation insertion, and
formatting in multiple journal styles.
• Mendeley: Free reference manager with a desktop app and browser plugin. Supports
collaboration and annotation.
• Zotero: Open-source, great for organizing sources and automatically detecting
citations from the web.
3.3 Literature Search Tools
• PubMed: Free database of biomedical literature. Primary search engine for peer-
reviewed articles.
• ScienceDirect & Scopus: Paid databases that offer journal access for literature reviews.
• Google Scholar: Useful for grey literature and citation tracking.
3.4 Plagiarism Checkers
• iThenticate: Preferred by journals and regulatory bodies.
• Grammarly Premium: Includes a plagiarism checker with writing enhancement tools.
• Turnitin: Often used in academic institutions. Not freely available but excellent for
bulk document checking.
3.5 Grammar and Style Enhancers
• Grammarly: Helps refine grammar, clarity, engagement, and delivery.
• Hemingway App: Assesses readability, sentence structure, and overuse of passive
voice.
• PerfectIt: A plugin for Word that checks consistency in spelling, abbreviations, and
styling.
3.6 Data Presentation Tools
• Microsoft Excel: Essential for organizing raw data, statistical calculations, and creating
tables.
• GraphPad Prism: Widely used for biostatistics, especially in life sciences and clinical
studies.
• Tableau / Power BI: For advanced data visualization.
3.7 PDF Management and Editing
• Adobe Acrobat Pro: For editing, commenting, and securing PDF files.
• PDF-XChange Editor: A lightweight tool for reviewing and annotating.
• Foxit Reader: An alternative to Adobe with collaborative features.
3.8 Online Writing and Collaboration Tools
• Trello / Asana: For managing tasks, deadlines, and document workflow.
• Slack / Microsoft Teams: For real-time team communication.
• Dropbox / Google Drive: For cloud storage and document version control.
3.9 Compliance and Guidelines Resources
• ICH Guidelines (ICH.org): Covers clinical study protocols, reporting, and Good
Clinical Practice (GCP).
• EudraLex: European regulatory guidelines.
• FDA.gov: US regulatory requirements and documentation standards.
• ICMJE: Guidelines for manuscript submission to biomedical journals.
3.10 Continuous Learning Platforms
• Coursera, Udemy, and LinkedIn Learning: Offer courses in scientific writing,
pharmacovigilance, and regulatory affairs.
• AuthorAID, Elsevier Researcher Academy: Free resources to improve research
communication skills.
• Writing Assistance Tools: Readable.io, Slick Write, ProWritingAid.
Module 4: Medical Marketing Writing
Medical marketing writing bridges the gap between complex medical data and patient-friendly
communication. It plays a crucial role in promoting drugs and devices ethically and effectively.
Types of Marketing Content
• Brochures: Designed for both healthcare professionals and patients, emphasizing
benefits, dosage, and precautions.
• Newsletters: Share updates on new drug research, clinical trial outcomes, or treatment
guidelines.
• Website Content: Informs and engages users with scientifically sound yet accessible
articles.
Patient Education Content
This involves simplifying jargon:
• "Hypertension" becomes "High blood pressure"
• "Myocardial infarction" becomes "Heart attack"
Educational content helps patients understand their conditions, adhere to treatment, and
recognize warning signs early.
Ethical Writing Principles
• Avoid exaggerated claims like “cures all pain instantly.”
• Always mention side effects and risks clearly.
• Align with marketing regulations from FDA, EMA, or CDSCO.
Ethical medical marketing earns trust, builds brand credibility, and supports informed patient
decisions.
Medical Marketing Writing
Medical marketing writing is a specialized form of communication that translates complex
medical and scientific information into clear, engaging, and ethical content tailored for
healthcare professionals, patients, and the general public. This type of writing helps
pharmaceutical companies, medical device manufacturers, and healthcare providers promote
products while ensuring that information remains accurate, balanced, and compliant with
regulatory standards.

1. Types of Marketing Content

Brochures:
• Purpose: To provide a concise overview of a drug or device, focusing on benefits,
proper use, dosage instructions, precautions, and contraindications.
 • Target Audience: Both healthcare professionals (HCPs) who prescribe or recommend
treatments and patients who use them.
• Style: Clear, persuasive, but factual language; use of bullet points, visuals, and easy-to-
read layouts to enhance comprehension.
Newsletters:
• Purpose: To keep healthcare professionals and stakeholders informed about recent
developments such as new clinical trial results, drug approvals, treatment guidelines, or
company news.
• Content: Summaries of recent studies, expert opinions, regulatory updates, and
educational tips related to disease management or product use.
• Style: Professional tone, with citations or references to scientific studies to build
credibility.
Website Content:
• Purpose: To engage a wide audience including patients, caregivers, and healthcare
providers by offering scientifically accurate yet accessible articles, FAQs, videos, and
interactive tools.
• Features: Articles explaining diseases, treatment options, lifestyle advice, and product
information. Content should be optimized for search engines (SEO) to increase
visibility.
• Style: Balanced, jargon-free language, with trust-building elements such as references,
disclaimers, and links to authoritative sources.

2. Patient Education Content

Patient education is a core component of medical marketing writing aimed at empowering
patients to manage their health effectively.
Simplifying Medical Jargon:
• Medical terms are often complex and intimidating to patients. The writer’s job is to
translate these into simple, everyday language without losing accuracy.
• Examples:
o “Hypertension” → “High blood pressure”
o “Myocardial infarction” → “Heart attack”
o “Antihypertensive medication” → “Medicine to lower blood pressure”
Purpose of Patient Education:
• Help patients understand their condition and why treatment is necessary.
• Improve medication adherence by clearly explaining dosage and possible side effects.
 • Alert patients to warning signs that require medical attention (e.g., signs of stroke,
allergic reactions).
• Encourage lifestyle changes that support treatment effectiveness (diet, exercise,
smoking cessation).

3. Ethical Writing Principles

Ethics in medical marketing writing are paramount to maintain public trust and comply with
legal frameworks.
Avoid Exaggerated Claims:
• Phrases like “cures all pain instantly” or “100% safe and effective” are misleading and
often false.
• Claims must be supported by scientific evidence from clinical trials or regulatory
approval documents.
Transparency on Risks and Side Effects:
• Every promotional material must clearly state potential side effects, contraindications,
and warnings.
• This ensures patients and healthcare providers can make informed decisions.
Compliance with Regulatory Guidelines:
• Follow regulations and codes set by bodies such as:
o FDA (U.S. Food and Drug Administration)
o EMA (European Medicines Agency)
o CDSCO (Central Drugs Standard Control Organization, India)
• These organizations provide guidelines on what can be claimed, how risk information
should be presented, and necessary disclaimers.
Benefits of Ethical Marketing:
• Builds trust with healthcare professionals and patients.
• Avoids legal penalties and reputational damage.
• Supports informed decision-making, leading to better health outcomes.
• Enhances brand credibility and long-term business sustainability.
1. Sample Brochure content
2. Sample Newsletter excerpt
3. Sample Patient Education content (leaflet)
1. Sample Brochure Content for a Diabetes Drug (Glycobeta)

Title:
Glycobeta® – Innovative Support for Managing Type 2 Diabetes

Introduction:
Glycobeta® is a once-daily oral medication designed to help adults with type 2 diabetes
lower blood sugar levels effectively and safely.

Benefits:
• Reduces HbA1c by an average of 1.5% over 12 weeks
• Improves blood sugar control alongside diet and exercise
• Well-tolerated with minimal side effects

Dosage & Administration:

• Recommended dose: 100 mg once daily, taken with or without food
• Adherence to prescribed dose is essential for best results

Precautions:
• Not recommended for patients with severe kidney or liver impairment
• Inform your doctor if you experience symptoms such as unusual fatigue, nausea, or
swelling
• Do not stop taking Glycobeta without consulting your healthcare provider

Side Effects:
Common side effects may include mild gastrointestinal discomfort and headache. Serious
adverse events are rare but seek medical help if you notice allergic reactions, severe rash,
or difficulty breathing.

Consult Your Doctor If:

• You experience persistent low blood sugar symptoms such as dizziness or confusion
• You have any concerns about interactions with other medications
Contact Information:
For more information, please visit www.glycobeta.com or call 1-800-123-4567

2. Sample Newsletter Excerpt for Healthcare Professionals

Title:
Latest Clinical Findings on Glycobeta®: A Promising New Option for Type 2 Diabetes

Body:
Dear Healthcare Provider,
Recent Phase 3 clinical trial results highlight Glycobeta’s efficacy in reducing HbA1c
levels by an average of 1.5% compared to 0.5% for placebo at 12 weeks (p < 0.001). The
randomized, double-blind, placebo-controlled study included 150 adults with type 2
diabetes who had inadequate glycemic control despite diet and exercise.
Glycobeta demonstrated a favorable safety profile with no significant increase in
hypoglycemia risk. These findings suggest Glycobeta could be a valuable addition to the
therapeutic arsenal for diabetes management.
Stay tuned for upcoming webinars on Glycobeta’s clinical applications and patient
management strategies.
Best regards,
Medical Affairs Team

3. Sample Patient Education Leaflet for Paracetamol (Acetaminophen)

Title:
Paracetamol: What You Need to Know

What is Paracetamol?
Paracetamol is a common medicine used to relieve pain and reduce fever.

How Does It Work?

Paracetamol works by blocking pain signals in the brain and helping to lower body
temperature when you have a fever.

How to Take Paracetamol:

• Follow the dosage instructions on the package or as advised by your doctor.
• Do not take more than 4,000 mg (usually 8 tablets of 500 mg) in 24 hours.
• If you have liver problems, consult your doctor before taking paracetamol.

Possible Side Effects:

• Usually safe when taken correctly.
• Rarely, it can cause allergic reactions such as rash or swelling.
• If you notice any unusual symptoms, stop taking the medicine and see a doctor
immediately.

When to Contact Your Doctor:

• If pain or fever lasts more than 3 days
• If you experience severe allergic symptoms (difficulty breathing, swelling of
face/throat)
• If you accidentally take more than the recommended dose

Remember:
• Keep paracetamol out of reach of children.
• Avoid taking other medicines that contain paracetamol to prevent overdose.

Why this works:

• Uses simple, everyday words (“pain,” “fever,” “block pain signals”)
• Short sentences and bullet points enhance readability
• Safety information is clear and accessible
• Encourages responsible use and consultation with healthcare providers
Module 5: Tools and Technologies for Medical Writing
Proficiency in digital tools significantly improves efficiency, collaboration, and accuracy in
medical writing.
Writing & Formatting Tools
• Microsoft Word: For structured document creation using templates and styles.
o Styles: Ensure consistency across headings and body text.
o Templates: Predefined layouts for CSRs, abstracts, and more.
Reference Management Tools
• EndNote & Mendeley: Organize and cite references in AMA, APA, or custom styles.
o Seamless integration with Word
o Auto-generation of bibliographies
Data Analysis Software
• GraphPad Prism: Used for creating scientific graphs and analyzing trial data.
• SPSS: Handles large datasets with complex statistical analysis for clinical studies.
Document Management Systems (DMS)
• Veeva Vault and similar platforms support:
o Version control
o Team collaboration
o Secure storage of trial documents
Mastering these tools equips writers for real-world job environments, particularly in CROs and
pharmaceutical MNCs.
Types of Documents Created by Medical Writers
Medical writers create a wide variety of documents tailored to specific audiences—regulatory
bodies, healthcare professionals, patients, or the general public. These documents differ in
structure, tone, and content complexity depending on their purpose.
4.1 Regulatory Documents
These are essential for drug approval and compliance with health authorities.
• Clinical Study Protocols (CSPs): Describe objectives, design, methodology, and
statistical analysis for clinical trials.
• Investigator Brochures (IBs): Provide clinical and non-clinical data on investigational
products for investigators.
• Clinical Study Reports (CSRs): Detailed summaries of study methods and results.
 • Informed Consent Forms (ICFs): Patient-facing documents outlining trial details and
consent requirements.
• Common Technical Documents (CTD): Standardized dossier for regulatory
submissions to agencies like FDA, EMA.
4.2 Scientific Publications
Target academic journals, conferences, or scientific forums.
• Research Manuscripts: Full-length articles on original research submitted to peer-
reviewed journals.
• Review Articles: Summarize existing research on a topic, highlight gaps and future
directions.
• Case Reports: Detailed reports of unusual or rare clinical cases.
• Conference Abstracts and Posters: Summarize key findings for presentation at
scientific conferences.
4.3 Medical Communications
Focus on healthcare professionals and patients.
• Slide Decks and Presentations: Used for medical education or product training.
• Product Monographs: Provide comprehensive information about a drug, including
usage, side effects, and dosing.
• Medical Newsletters: Share clinical updates, trial data, or treatment guidelines.
• Patient Information Leaflets (PILs): Simplified, readable documents for patient
education.
4.4 Medical Marketing and Promotional Material
These documents support drug marketing within ethical and regulatory limits.
• Sales Aids / Detail Aids: Visual tools used by medical representatives during product
promotion.
• Leave-Behinds: Concise documents left with HCPs for quick reference.
• Website Content and Email Campaigns: For product promotion or disease
awareness.
• Banner Ads / Social Media Posts: Designed for digital marketing campaigns with
compliance considerations.
4.5 Educational and Training Content
Supports knowledge transfer in institutions or corporates.
• Continuing Medical Education (CME) Modules: Accredited learning content for
HCPs.
 • E-learning Courses and Storyboards: Digital training for pharmaceutical staff or
healthcare professionals.
• Standard Operating Procedures (SOPs): Instructional documents outlining routine
procedures in labs or clinical settings.
4.6 Health Journalism and Consumer Health Writing
Bridges the gap between science and the public.
• Health Articles and Blogs: Address disease prevention, wellness tips, or latest medical
breakthroughs.
• Q&A Columns and FAQ Documents: Simplify complex medical topics for
laypersons.
• Press Releases: Announce clinical trial milestones, product launches, or company
updates.
4.7 Other Specialized Documents
• Medical Device Documentation: Includes technical files, risk assessments, and IFUs
(Instructions for Use).
• Pharmacovigilance Reports: Like Periodic Safety Update Reports (PSURs) or
Individual Case Safety Reports (ICSRs).
• Grant Proposals and Funding Applications: Used to request research funding from
government or private bodies.
• Regulatory Briefing Documents: Prepared for agency meetings (e.g., pre-IND,
advisory committee).
Scientific Literature Review and Referencing
A core responsibility of medical writers is conducting scientific literature reviews and citing
references correctly. This module will provide an in-depth understanding of how to search,
analyze, summarize, and reference published scientific content.

5.1 Introduction to Literature Review

A literature review involves systematically identifying, evaluating, and summarizing published
research on a specific topic. In medical writing, this helps:
• Understand existing research
• Identify knowledge gaps
• Support arguments with credible evidence
• Create background for new studies
Types of literature reviews:
• Narrative Reviews: Broad overview without strict methodology
 • Systematic Reviews: Follows a structured protocol with inclusion/exclusion criteria
• Meta-Analyses: Combines statistical data from multiple studies

5.2 How to Conduct a Literature Review

Step 1: Define Your Topic and Scope
• Formulate a focused question using PICO (Population, Intervention, Comparison,
Outcome)
• Define the inclusion and exclusion criteria for studies
Step 2: Search Databases
• PubMed: Best for biomedical literature
• Google Scholar: Broad search tool
• ScienceDirect, Scopus, Embase: Institutional access may be required
Step 3: Use Keywords and Boolean Operators
• Combine keywords using AND, OR, NOT
• Use MeSH terms in PubMed for standardized searches
Step 4: Screen and Select Articles
• Review titles and abstracts first
• Filter out duplicates and irrelevant results
Step 5: Extract and Organize Information
• Use data extraction tables
• Identify study design, sample size, outcomes, limitations

5.3 Referencing and Citation Styles

Referencing shows where your information came from. It enhances credibility and prevents
plagiarism.
Common citation styles:
• Vancouver Style: Numeric referencing. Common in biomedical journals.
• APA Style: Author-date format. Used in social sciences and some healthcare fields.
• AMA Style: Author-number format. Widely used in medical publications.
Examples:
• Vancouver: "Antibiotics are frequently overprescribed in outpatient settings [1]."
 • APA: "Antibiotics are frequently overprescribed in outpatient settings (Smith, 2021)."
• AMA: "Antibiotics are frequently overprescribed in outpatient settings.1"

5.4 Tools for Managing References

Reference Management Software:
• EndNote: Preferred in academia and pharma industry
• Mendeley: Free tool with collaboration options
• Zotero: Great for online article capture and citation management
Functions:
• Store article PDFs
• Annotate and highlight within the software
• Insert in-text citations and generate bibliographies

5.5 Avoiding Plagiarism

Plagiarism is using someone else's words or ideas without giving credit.
How to avoid it:
• Paraphrase effectively
• Use quotation marks for direct quotes
• Always cite your sources
Plagiarism Check Tools:
• iThenticate
• Turnitin
• Grammarly (Premium)

5.6 Best Practices

• Always verify the credibility of your sources (peer-reviewed journals > news articles >
blogs)
• Keep a reference log or spreadsheet
• Follow journal-specific citation formats
• Cross-check every in-text citation with the reference list
• Update literature reviews regularly to include recent findings
Module 6: Key Skills for Medical Writers
Success in medical writing depends on a blend of technical, analytical, and language skills.
Interpreting Clinical Data
Writers must:
• Understand trial design (e.g., randomized, double-blind)
• Evaluate endpoints (e.g., reduction in HbA1c or PFS)
• Verify statistical results (e.g., p-values, confidence intervals)
Clinical Trial Phases

Phase Purpose Key Docs

I Safety in small groups IB, Consent Forms

II Efficacy and dosing CTP, CRFs

III Large-scale comparison CSR, Amendments

IV Post-marketing data RMP, Surveillance Reports

Editing and Proofreading

Writers ensure:
• Accuracy of terms and drug names
• Consistency of formatting and headings
• Correct grammar and scientific clarity
Plagiarism & Integrity
Tools like Turnitin and Grammarly help avoid unintentional plagiarism and check readability.
A good medical writer is also a strong editor—capable of presenting validated, error-free
content.
Introduction to Regulatory Writing
Regulatory writing involves preparing documents that support the approval of drugs, biologics,
and medical devices by health authorities like:
• US FDA (Food and Drug Administration)
• EMA (European Medicines Agency)
• CDSCO (Central Drugs Standard Control Organization, India)
It includes both clinical and non-clinical documentation.
6.2 Key Regulatory Documents
1. Investigator’s Brochure (IB)
• Summarizes clinical and non-clinical data about the investigational product
• Used by investigators during clinical trials
2. Clinical Study Protocol (CSP)
• Outlines objectives, design, methodology, and statistical considerations for a clinical
trial
3. Clinical Study Report (CSR)
• Provides comprehensive results and interpretations of a completed clinical trial
• Follows the ICH E3 guideline
4. Common Technical Document (CTD)
• Standard format used globally for submitting applications for new drugs
• Divided into 5 Modules:
o Module 1: Regional Information
o Module 2: Summaries (e.g., quality, non-clinical, clinical)
o Module 3: Quality
o Module 4: Nonclinical Study Reports
o Module 5: Clinical Study Reports
5. Informed Consent Form (ICF)
• Ensures participants understand the clinical trial, risks, and rights

6.3 Guidelines and Standards to Follow

• ICH Guidelines (e.g., ICH E3 for CSRs, ICH E6 for GCP)
• GCP (Good Clinical Practice)
• 21 CFR Part 11 for electronic records
• EMA and FDA Submission Requirements

6.4 Writing Style and Language

• Use clear, concise, and objective language
• Avoid jargon unless necessary (define if used)
 • Ensure logical flow and headings for easy navigation
• Always use active voice when possible: "The study showed…" instead of "It was
shown that…"
• Maintain neutral tone—do not overstate findings

6.5 Data Presentation

• Present data using tables, figures, and listings clearly
• Summarize key findings in the text, referencing the detailed tables
• Ensure consistency in:
o Numbers and decimal places
o Units of measurement
o Terminology (use a study-specific style guide if available)

6.6 Common Challenges

• Interpreting complex clinical data
• Managing tight deadlines
• Ensuring compliance with changing regulations
• Coordinating input from multiple stakeholders (clinicians, statisticians, regulatory
teams)

6.7 Best Practices

• Know your audience: Regulatory reviewers need precise and clear documentation
• Stay updated: Regulatory requirements evolve frequently
• Use document templates aligned with ICH and regional requirements
• Maintain version control and document history
• Quality check every document for formatting, referencing, and completeness
Module 7: Career Preparation for Medical Writing
This module helps aspiring medical writers transition from academic backgrounds into
professional roles by focusing on career-building essentials.

Writing a Job-Specific CV
Your CV should be concise, tailored, and highlight relevant skills like:
• Knowledge of AMA style, clinical terminology, and trial phases
• Proficiency in tools like MS Word, EndNote, and Mendeley
• Certifications (e.g., Medical Writing, Clinical Research)
Example Sections:
• Objective: "Aspiring medical writer with a background in pharmacy and a passion for
scientific communication."
• Skills: Clinical writing, referencing, formatting, trial document handling
• Experience: Internships, freelance blogs, or personal writing projects
• Certifications: Online courses, workshops, or recognized diplomas

Building a Strong LinkedIn Profile

LinkedIn acts as a digital resume. Key steps:
• Use keywords in the headline: "Medical Writing Enthusiast | B.Pharm Graduate"
• Write a compelling summary
• Upload sample documents (abstracts, case studies, mock CSRs)
• Connect with recruiters, join pharma/medical writing groups
A standout LinkedIn profile and focused CV significantly boost job visibility.
Clinical Trial Documentation and Medical Writing Roles
Clinical trial documentation is essential for planning, conducting, monitoring, and reporting
clinical trials. Medical writers play a key role in producing and managing this documentation
in compliance with Good Clinical Practice (GCP) and regulatory guidelines. This module
explains the types of clinical trial documents, their purpose, and how medical writers contribute
at each stage.

7.1 Introduction to Clinical Trial Documentation

Clinical trials generate vast amounts of documentation to ensure:
 • Ethical conduct of research
• Participant safety
• Scientific validity
• Regulatory compliance
These documents are reviewed by sponsors, regulatory agencies, ethics committees, and
sometimes the public. Well-prepared documents reduce regulatory delays and support product
approval.

7.2 Types of Clinical Trial Documents

Clinical trial documents can be grouped into essential documents and supporting documents.
Each document serves a specific function during the trial lifecycle.
1. Pre-Trial Documents:
• Clinical Study Protocol (CSP): Describes the study objectives, design, methodology,
statistical plan, and ethical considerations.
• Investigator’s Brochure (IB): Compiles preclinical and clinical data on the
investigational product.
• Informed Consent Form (ICF): Ensures participants understand the trial and
voluntarily consent to join.
• Case Report Forms (CRFs): Used for collecting trial data from each participant.
2. Trial Conduct Documents:
• Monitoring Reports: Assess compliance with protocol and GCP.
• Amendments: Any changes made to the protocol or consent form during the study.
• Safety Reports: Include SAE (Serious Adverse Event) reports and SUSARs (Suspected
Unexpected Serious Adverse Reactions).
3. Post-Trial Documents:
• Clinical Study Report (CSR): Final analysis and summary of trial results, following
ICH E3.
• Statistical Analysis Plan (SAP): Details the methodology for data analysis.
• Trial Master File (TMF): A complete set of documents showing the trial was
conducted in accordance with regulations.

7.3 Medical Writer's Role at Different Trial Stages

During Study Design:
• Drafting and reviewing the Clinical Study Protocol and Informed Consent Forms.
 • Collaborating with clinical and regulatory teams to ensure scientific clarity and
accuracy.
During Study Conduct:
• Assisting in protocol amendments.
• Writing interim safety summaries and annual safety reports (e.g., DSUR).
• Updating the Investigator’s Brochure with new data.
After Study Completion:
• Writing the Clinical Study Report.
• Summarizing results for public disclosure on registries (e.g., ClinicalTrials.gov).
• Contributing to manuscripts, posters, and abstracts for scientific publication.

7.4 Document Standards and Compliance

All clinical trial documents must comply with:
• ICH-GCP (E6): Ensures trial integrity and participant safety.
• ICH-E3: Format for Clinical Study Reports.
• Regulatory guidelines from agencies like FDA, EMA, and CDSCO.
• 21 CFR Part 11: For electronic records and signatures.
Key principles:
• Accuracy and completeness
• Traceability and version control
• Timely documentation

7.5 Writing Style for Clinical Trial Documents

• Clarity and Precision: Use unambiguous, scientific language.
• Consistency: Terminology and abbreviations must be consistent across all documents.
• Structured Format: Follow templates or regulatory guidance (e.g., ICH E3 for CSRs).
• Data Integrity: All data summaries should match source documents and statistical
outputs.
• Neutral Tone: Avoid promotional or biased language.

7.6 Common Challenges and Solutions

Challenge Solution

Work closely with biostatisticians and data

Interpreting complex trial data
managers

Regulatory complexity Stay updated with regional and ICH guidelines

Use document templates and project planning

Tight timelines
tools

Managing reviews from multiple Use version control and centralized feedback
stakeholders tracking
Module 8: Interview Preparation
Medical writing interviews test both writing competency and industry knowledge. This module
helps candidates prepare confidently.
Common Questions
1. Explain the structure of a CSR
2. How do you simplify technical data for patients?
3. Describe a time you edited scientific content
Mock Scenarios
• Protocol Simulation: You're asked to write a protocol for a new hypertension drug—
highlighting objectives, study design, and endpoints.
• Patient Leaflet Revision: Simplify a drug leaflet with minimal jargon.
Tips for Success
• Practice concise and confident communication.
• Demonstrate awareness of GCP, ICH guidelines, and drug development.
• Use the STAR method for situational answers: Situation, Task, Action, Result.
Prepared candidates stand out by linking technical knowledge with real-world application.
Publication Writing – Manuscripts, Abstracts, and Posters
Medical writers often contribute to scientific publications that share study results and medical
insights with the global community. These publications include manuscripts, abstracts, and
posters prepared for submission to peer-reviewed journals or presentation at scientific
conferences. This module will explain how to write these documents with clarity, scientific
rigor, and adherence to publication guidelines.

8.1 Introduction to Publication Writing

Publication writing aims to:
• Disseminate study findings
• Educate clinicians and researchers
• Support regulatory or marketing objectives
• Advance the body of scientific knowledge
Key principles of publication writing:
• Scientific accuracy
• Objectivity
 • Clarity and conciseness
• Compliance with ethical and journal standards
Common publication types:
• Original research articles
• Review articles
• Case reports
• Conference abstracts
• Posters and oral presentations

8.2 Manuscript Writing: IMRAD Structure

Most scientific manuscripts follow the IMRAD structure:
I – Introduction
• Background and context
• Rationale for the study
• Study objectives/hypothesis
M – Methods
• Study design
• Inclusion/exclusion criteria
• Data collection and analysis
• Ethical approval
R – Results
• Participant flow (CONSORT diagram if clinical trial)
• Key findings using text, tables, and figures
• Avoid interpretation in this section
A – And
(no content – this connects Methods and Results)
D – Discussion
• Interpretation of findings
• Comparison with other studies
• Study limitations
 • Future research directions
• Conclusion
Other Sections:
• Title Page: Includes authorship and affiliations
• Abstract: Structured or unstructured summary
• Keywords: 3–7 relevant terms
• References: Cited using journal’s required style

8.3 Writing Conference Abstracts

Abstracts are short summaries of research work submitted to scientific conferences. They
should:
• Fit the word limit (typically 250–350 words)
• Include the study background, objectives, methods, results, and conclusions
• Use clear and direct language
• Avoid data tables unless allowed
Tips:
• Highlight the novelty and relevance of your research
• Avoid unnecessary technical jargon
• Ensure consistency with your final manuscript/poster

8.4 Scientific Posters

Posters visually present research findings at conferences and should:
• Be concise and visually engaging
• Use bullet points and figures instead of long text
• Include sections similar to the IMRAD format
Poster Components:
• Title and authorship (top of the poster)
• Introduction and objectives
• Methods and materials
• Key results (figures, tables, graphs)
• Summary/conclusion
 • References and acknowledgments
Design Tips:
• Use clear headings and color contrasts
• Keep text large enough for reading from 1–2 meters
• Use visuals (graphs, images) for clarity

8.5 Authorship and Ethics in Publication

Follow ICMJE Guidelines for authorship:
• Substantial contribution to study design/data
• Drafting or revising the manuscript
• Approval of the final version
• Accountability for all parts of the work
Ethical Considerations:
• No ghost authorship or honorary authorship
• Disclose conflicts of interest
• Avoid duplicate publications
• Follow journal-specific ethical policies (COPE, ICMJE)

8.6 Common Journal Guidelines

Different journals have specific requirements:
• Word counts (e.g., 3,000–5,000 words for research articles)
• Citation formats (Vancouver, AMA, APA)
• Submission format (Word document, PDF, structured template)
• Cover letter: A short letter to the editor describing the manuscript's significance
Resources:
• Journal websites (Instructions for Authors)
• EQUATOR Network (e.g., CONSORT, STROBE, PRISMA checklists)
• AuthorAid (support for first-time authors)

8.7 Tools and Software

Helpful tools for publication writing:
• Reference Managers: EndNote, Mendeley, Zotero
• Plagiarism Checkers: iThenticate, Turnitin
• Grammar Checkers: Grammarly, Hemingway App
• Figure Creators: GraphPad Prism, BioRender

8.8 Common Challenges

Challenge Solution

Writing for a non-technical

Simplify complex information without losing accuracy
audience

Multiple author inputs Use tracked changes and clear version control

Tight word limits Prioritize key information and concise language

Address reviewers’ comments, consider submitting to

Rejections from journals
another journal
Module 9: Practice Exercises & Case Studies
This hands-on module reinforces learning through simulations of real writing tasks.
Exercise 1: Draft a CSR
For a fictional diabetes drug (Glycobeta), write:
• Title, Methodology, Results, and Conclusion
• Include statistical insights (e.g., HbA1c drop by 1.5% vs. placebo 0.5%)
Exercise 2: Write an Abstract
For a study comparing a low-glycemic diet with a standard diet in diabetes patients. Follow
IMRAD format and keep it concise.
Exercise 3: Summarize a Leaflet
Take a technical drug description (e.g., mechanism of paracetamol) and rewrite it in simple,
understandable language for patients.
These exercises simulate actual job responsibilities and strengthen writing confidence.
Exercise 1: Draft a Clinical Study Report (CSR)
Title:
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of
Glycobeta 100 mg in Adults with Type 2 Diabetes

Methodology:
This was a 12-week, randomized, double-blind, placebo-controlled clinical trial conducted to
assess the efficacy and safety of Glycobeta, a novel antidiabetic agent, in adults diagnosed with
type 2 diabetes mellitus. A total of 150 participants aged 30-65 years with baseline HbA1c
levels between 7.0% and 10.0% were enrolled. Subjects were randomly assigned in a 1:1 ratio
to receive either Glycobeta 100 mg once daily or matching placebo. The primary endpoint was
the change in HbA1c from baseline to week 12. Secondary endpoints included fasting plasma
glucose levels and safety assessments including adverse events (AEs), vital signs, and
laboratory parameters. All participants provided informed consent, and the study adhered to
Good Clinical Practice guidelines.

Results:
Out of 150 randomized patients, 145 completed the study (72 in Glycobeta group, 73 in placebo
group). Glycobeta demonstrated a statistically significant reduction in HbA1c levels compared
to placebo at week 12. The mean HbA1c decreased by 1.5% (±0.3) in the Glycobeta group
versus 0.5% (±0.2) in the placebo group (p < 0.001). Additionally, fasting plasma glucose
decreased by 25 mg/dL in the treatment group compared to 8 mg/dL in placebo (p = 0.002).
Safety analysis revealed mild adverse events such as headache and nausea, occurring in 10%
of Glycobeta patients and 8% of placebo patients, with no serious adverse events reported.
Conclusion:
Glycobeta 100 mg once daily significantly improves glycemic control in adults with type 2
diabetes over 12 weeks, with a favorable safety profile. These findings support Glycobeta as a
promising therapeutic option for managing type 2 diabetes. Further long-term studies are
warranted to assess sustained efficacy and safety.

Exercise 2: Write an Abstract (IMRAD format)

Title:
Effects of a Low-Glycemic Diet versus Standard Diet on Glycemic Control in Patients with
Type 2 Diabetes: A Randomized Controlled Trial
Abstract:
Introduction:
Effective dietary interventions are essential for managing type 2 diabetes mellitus (T2DM).
This study aimed to compare the effects of a low-glycemic diet (LGD) with a standard diet
(SD) on blood sugar control in T2DM patients.
Methods:
In this 12-week randomized controlled trial, 120 adults with T2DM were assigned to either
LGD or SD groups. The primary outcome was the change in HbA1c levels. Secondary
outcomes included fasting blood glucose and body weight. Dietary adherence was monitored
through food diaries.
Results:
Participants in the LGD group experienced a significant reduction in HbA1c (-1.2%, SD ±0.4)
compared to the SD group (-0.6%, SD ±0.3) (p < 0.001). Fasting blood glucose decreased by
20 mg/dL in the LGD group versus 8 mg/dL in the SD group (p = 0.004). No significant
difference in weight loss was observed between groups.
Conclusion:
A low-glycemic diet significantly improves glycemic control in T2DM patients compared to a
standard diet, suggesting dietary glycemic index reduction as an effective management
strategy. These results encourage the incorporation of LGD in routine diabetes care.

Exercise 3: Summarize a Patient Leaflet (Paracetamol mechanism)

Paracetamol (Acetaminophen) – What You Need to Know
What is Paracetamol?
Paracetamol is a common medicine used to relieve pain and reduce fever. It is often used for
headaches, muscle aches, colds, and fevers.
How Does It Work?
Paracetamol works by blocking signals in your brain that tell you there is pain. It also helps
lower fever by acting on the brain's temperature control center.
How to Take Paracetamol:
• Take the dose recommended by your doctor or as written on the package.
• Do not take more than 4 grams (4000 mg) in 24 hours.
• Space doses at least 4 to 6 hours apart.
Possible Side Effects:
• Usually safe when taken correctly.
• Some people may experience allergic reactions, skin rash, or stomach upset.
• Overuse can cause serious liver damage.
When to See a Doctor:
• If your pain or fever lasts more than 3 days.
• If you notice yellowing of skin or eyes, or severe stomach pain.
• If you accidentally take too much paracetamol.
Tips:
• Avoid drinking alcohol while taking paracetamol.
• Check other medicines for paracetamol to avoid accidental overdose.
Module 10: Membership & Growth Opportunities
Professional development is continuous in medical writing. This module guides learners on
where to go next.
Professional Associations
• AMWA (American Medical Writers Association)
• EMWA (European Medical Writers Association)
Membership benefits: certifications, webinars, job boards, networking
Freelance Opportunities
Platforms like:
• Upwork, Fiverr, Freelancer, and LinkedIn Jobs
Tips:
• Start small to build reviews
• Present samples of abstracts, summaries, or case reports
• Build a strong freelancer profile with testimonials
Staying Updated
Follow industry blogs and journals:
• PubMed, UpToDate, Medical Writing blogs
• Attend free/paid webinars on regulatory updates, AI in writing, and more
 LINKS:

1. Clinical Study Report (CSR) Templates

• ICH E3 Guideline (Clinical Study Reports Template) — Official
The International Council for Harmonisation (ICH) provides a detailed guideline for
CSR format, which you can adapt as a template.
Link: https://database.ich.org/sites/default/files/E3_Guideline.pdf

• University of California - CSR Template (Example)

A useful example CSR template from an academic setting to understand typical
sections.
Link:
https://www.pharmacy.ucsf.edu/sites/pharmacy.ucsf.edu/files/clinical_study_report_te
mplate.pdf
•

• FDA Clinical Review Templates

FDA sometimes publishes example clinical reviews and summaries that can guide
CSR writing.
Link: https://www.fda.gov/drugs/development-approval-process-drugs/fda-drug-
review-templates

2. Abstract Writing Templates

• Purdue OWL - Writing Abstracts
Great academic resource explaining abstract structure with examples.
Link:
https://owl.purdue.edu/owl/subject_specific_writing/writing_in_the_social_sciences/
writing_in_psychology/abstracts.html
• University of Leicester - Abstract Writing Guide
Includes templates and tips for writing scientific abstracts.
Link: https://www2.le.ac.uk/offices/ld/resources/writing/writing-resources/abstracts
• Elsevier Publishing Campus – Abstract Template
Free courses and templates for scientific writing including abstracts.
Link: https://www.publishingcampus.elsevier.com/pages/scientific-writing/

3. Patient Leaflet Templates and Examples

• MHRA (UK) - Patient Information Leaflet Templates
Official templates and guidance on writing patient information leaflets.
 Link: https://www.gov.uk/government/publications/pil-guidance-patient-information-
leaflets
• National Health Service (NHS) – Patient Leaflets
Real examples and guidelines from NHS leaflets designed for patient communication.
Link: https://www.nhs.uk/conditions/medicines-information/
• MedlinePlus - How to Understand and Use Patient Leaflets
Guide and examples to make patient information clear and accessible.
Link: https://medlineplus.gov/medications.html

4. Medical Marketing Content Templates

• HubSpot – Free Marketing Templates
While not exclusive to medical marketing, HubSpot offers brochure, newsletter, and
website content templates you can adapt.
Link: https://www.hubspot.com/resources/templates
• Canva – Medical Brochure Templates
Free brochure templates with medical themes, customizable online.
Link: https://www.canva.com/templates/brochures/medical/
• Pharma Marketing Network – Sample Materials
Some free downloadable pharma marketing materials and examples (requires sign-
up).
Link: https://pharmamktingnetwork.com/resources/

Reference Writing:

1. AMA (American Medical Association) Style

• AMA Manual of Style Online (Official guide excerpt and FAQs)
The official AMA Style is behind a paywall, but the AMA website provides useful
free tips and FAQs.
Link: https://www.amamanualofstyle.com/page/faq
• University of Maryland – AMA Citation Style Guide
Clear examples for in-text citations and reference lists in AMA style.
Link: https://guides.lib.umd.edu/c.php?g=326120&p=2182657
• Northwestern University Library – AMA Citation Guide
Quick reference for AMA style formatting with examples.
Link: https://guides.library.northwestern.edu/ama
• Purdue OWL – AMA Style Quick Guide
Concise summary of AMA style citations and references.
Link:
 https://owl.purdue.edu/owl/research_and_citation/ama_style/ama_formatting_and_sty
le_guide.html

2. Vancouver Style
• ICMJE (International Committee of Medical Journal Editors)
Recommendations
The Vancouver style is based on these widely used recommendations.
Link: http://www.icmje.org/recommendations/browse/manuscript-
preparation/preparing-for-submission.html#references
• University of Western Australia – Vancouver Style Guide
Practical examples of Vancouver in-text citations and bibliography.
Link: https://guides.library.uwa.edu.au/citing/vancouver
• Citing Medicine (NLM) – Vancouver Style
Official National Library of Medicine guide on Vancouver referencing.
Link: https://www.ncbi.nlm.nih.gov/books/NBK7256/

3. APA Style (7th Edition)

• APA Style Official Website
Free tutorials and sample papers from the APA style team.
Link: https://apastyle.apa.org/style-grammar-guidelines/references
• Purdue OWL – APA Style Guide
Comprehensive online resource with examples and formatting tips.
Link:
https://owl.purdue.edu/owl/research_and_citation/apa_style/apa_formatting_and_style
_guide.html
• Scribbr APA Citation Generator and Guide
Free citation generator with detailed guides.
Link: https://www.scribbr.com/apa-citation-generator/

4. General Medical Writing and Citation Help

• Citing Medicine (NLM)
A comprehensive style guide for biomedical sciences citation and referencing.
Link: https://www.ncbi.nlm.nih.gov/books/NBK7256/
• EndNote AMA Style Reference
EndNote provides AMA style templates and examples.
Link: https://endnote.com/style_download/ama/
Medical Terminology and Abbreviations Used in Regulatory & Scientific Writing

Term /
Meaning / Full Form Notes / Context
Abbreviation

Any unfavorable medical

AE Adverse Event
occurrence in a patient.

A harmful or unintended reaction

ADR Adverse Drug Reaction
to a drug.

The biologically active

API Active Pharmaceutical Ingredient
component of a drug.

Measure of body fat based on

BMI Body Mass Index
height and weight.

BP Blood Pressure Measurement of arterial pressure.

Statistical range within which a

CI Confidence Interval
parameter lies.

Document to collect data in

CRF Case Report Form
clinical trials.

Comprehensive report on clinical

CSR Clinical Study Report
trial results.

Research study with human

CT Clinical Trial
participants.

Oversees safety and efficacy data

DMC Data Monitoring Committee
in trials.

Annual safety update for

DSUR Development Safety Update Report
investigational drugs.

Effectiveness of a drug or treatment in

Efficacy Used in clinical trial results.
producing desired effect

Regulatory body in Europe for

EMA European Medicines Agency
drug approval.

US regulatory authority for drugs

FDA Food and Drug Administration
and devices.

Ethical and scientific quality

GCP Good Clinical Practice
standards for trials.
Term /
Meaning / Full Form Notes / Context
Abbreviation

Blood sugar control marker over

HbA1c Hemoglobin A1c
past 3 months.

Document to inform and get

ICF Informed Consent Form
consent from trial subjects.

International Council for Organization setting global

ICH
Harmonisation regulatory standards.

Introduction, Methods, Results, and Common structure for scientific

IMRAD
Discussion papers.

FDA application for new drug

IND Investigational New Drug
trials.

Committee that reviews ethics of

IRB Institutional Review Board
clinical trials.

Treatment boosting immune

IT Immunotherapy
system.

IV Intravenous Administration of drugs via vein.

Document granting permission

LOA Letter of Authorization
for clinical trial conduct.

Medical Dictionary for Regulatory Standardized medical

MedDRA
Activities terminology dictionary.

Application to FDA for drug

NDA New Drug Application
approval.

Drugs available without

OTC Over-the-Counter
prescription.

PD Pharmacodynamics Study of drug effects on the body.

Study of economic aspects of drug

PE Pharmacoeconomics
therapy.

Study of drug absorption,

PK Pharmacokinetics
distribution, metabolism.

PI Principal Investigator Lead researcher for a clinical trial.

Term /
Meaning / Full Form Notes / Context
Abbreviation

Patient information leaflet

PL Package Leaflet
included with medication.

Monitoring drug safety after

PMS Post-Marketing Surveillance
market approval.

PRO Patient-Reported Outcome Data reported directly by patients.

Heart rhythm measurement to

QTc Corrected QT Interval
assess drug safety.

Adverse event causing death,

SAE Serious Adverse Event
hospitalization, etc.

Detailed plan for statistical

SAP Statistical Analysis Plan
evaluation in trials.

Established procedures for

SOP Standard Operating Procedure
consistency in trials.

Document summarizing drug info

SPC Summary of Product Characteristics
for healthcare pros.

AE occurring after treatment

TEAE Treatment-Emergent Adverse Event
starts.

Highest value considered normal

ULN Upper Limit of Normal
for lab tests.

WHO World Health Organization Global public health agency.

Additional Common Medical Writing Abbreviations

Abbreviation Meaning

vs. Versus (comparison)

et al. And others (used in citations)

eg. For example

ie. That is

N/A Not applicable

n Number of subjects or samples

SD Standard deviation

SE Standard error

CI Confidence interval

p-value Probability value (statistical significance)

National & International Regulatory Guidelines in Medical Writing
International Guidelines

Guideline /
Full Form / Document Name Purpose
Body

International Council for Provides unified standards for

ICH-GCP Harmonisation - Good Clinical designing, conducting, and reporting
Practice clinical trials globally.

ICH Guideline for Clinical Study Provides structure for writing a Clinical
ICH-E3
Reports Study Report (CSR).

Harmonized format for submitting

Common Technical Document
ICH-M4 applications to regulatory authorities
(CTD)
(Modules 1–5).

Integrated Addendum to GCP Emphasizes data integrity, risk

ICH-E6(R2)
Guideline management, and sponsor oversight.

Medical Dictionary for Regulatory Standardized terminology for coding

MedDRA
Activities adverse events.

Covers essential medicines, vaccines,

WHO World Health Organization Technical
pharmacovigilance, and public health
Guidelines Reports & Guidelines
standards.

Guidelines for safety reporting,

Council for International
CIOMS pharmacovigilance, and informed
Organizations of Medical Sciences
consent.

Consolidated Standards of Reporting Guidelines for reporting randomized

CONSORT
Trials controlled trials.

Preferred Reporting Items for

Guidelines for writing systematic
PRISMA Systematic Reviews and Meta-
reviews and meta-analyses.
Analyses

Strengthening the Reporting of

STROBE Observational Studies in Used for observational studies.
Epidemiology

Standard Protocol Items:

SPIRIT Recommendations for Interventional Protocol development for clinical trials.
Trials

Good Pharmacoepidemiology Issued by ISPE for observational drug

ISPE GPP
Practices safety studies.
Indian National Guidelines

Guideline /
Full Form / Description Purpose
Body

Central Drugs Standard Control India’s national regulatory authority

CDSCO
Organization for drugs and clinical trials.

ICMR Indian Council of Medical Research Ethical guidance for biomedical and
Guidelines Guidelines for Biomedical Research health research in India.

Governs clinical trial approval, ethics

NDCT Rules,
New Drugs and Clinical Trials Rules committees, and compensation in
2019
India.

Gazette Notification for BA/BE Regulation for bioavailability and

GSR 227(E)
Studies bioequivalence studies.

Outlines requirements for clinical

Schedule Y Part of Drugs and Cosmetics Rules
trials, approval of new drugs, etc.

Pharmacovigilance Programme of Monitors adverse drug reactions and

PvPI
India signals in post-marketing phase.

Regulatory Bodies & Submission Portals

Authority / Portal Region Role

FDA (U.S. Food and Drug Approves new drugs, biologics,

USA
Administration) devices, and monitors safety.

EMA (European Medicines Evaluates medicinal products

Europe
Agency) for EU.

MHRA (Medicines and

UK’s regulatory body for drug
Healthcare products Regulatory UK
approval and safety.
Agency)

PMDA (Pharmaceuticals and Regulates drugs and medical

Japan
Medical Devices Agency) devices in Japan.

TGA (Therapeutic Goods Regulates therapeutic goods in

Australia
Administration) Australia.

National Health Surveillance

ANVISA Brazil
Agency regulating medicines.
Authority / Portal Region Role

South African Health Products

SAHPRA South Africa
Regulatory Authority.

Standard format for electronic

Electronic Common
eCTD submissions to regulatory
Technical Document
authorities.

Regulatory pathways for drug

Investigational New Drug
US IND / NDA trials and marketing approval in
/ New Drug Application
the U.S.

Documentation Guidelines for Medical Writers

Document Type Guideline to Follow

Clinical Study Reports ICH E3

Investigator’s Brochure ICH E6, GCP

Informed Consent Documents ICMR (India), CIOMS

Common Technical Document (CTD) ICH M4

Protocol Writing SPIRIT Guidelines

Adverse Event Reporting ICH E2A, MedDRA Coding

Pharmacovigilance Documents DSUR (Development Safety Update Report), PBRER