Description
The Diploma in Medical Writing (PDMW) is an online eLearning course that has been tailor-made to enhance a participant’s skill in medical writing. In this program you will learn and practice scientific writing, consumer health writing, medico-marketing writing and clinical research writing for regulatory authorities.
The Diploma in Medical Writing program is made up of 14 modules, 85 topics and 86 Quizzes. It covers the overview of clinical research, Epidemiology, Pharmaceutical medicines and good medical writing practices. The course throughly covers the regulatory, marketing and drug promotion process and explains how Protocol, Investigator’s Brochure and Case Report Forms are designed. In this program you will learn how to create the Common Technical Document (CTD) and write Clinical Study Reports (CSR). The areas of Publication writing and medico-marketing are also covered in detail.
Apart from the technical aspects of producing clinical documents, this course lays a strong focus of achieving high-quality output. To achieve this it covers the concepts of Sentence control, maintaining writing flow & cohesiveness and managing the document review process to ensure you understand the methodology of achieving desired quality in the medical writing process.
On completing your enrolment for the program you will instantly get access to our online learning portal.
Find more information about the field of Medical Writing – What is Medical Writing
Curriculum
Course Stats – 14 Modules, 85 Chapters, 86 Quizzes
Module 1 – General Introduction
- Pharmaceutical & CR – Industry Overview
- Introduction to Clinical Research
- Stakeholders and Roles in Clinical Research
- History and Milestones in Clinical Research
- Principles of Good Clinical Practice
- Technologies in Clinical Trial Management
- Overview of Clinical Research Regulatory Bodies
Module 2 – Epedemiology and Evidence Based Medicine (EBM)
- Epidemiology 1 – Introduction
- Epidemiology 2 – Concept of Causation
- Epidemiology 3 – Epedemiological Study Designs
- Epidemiology 4 – Statistics
- Evidence Based Medicine
Module 3 – Pharmaceutical Medicine
- Introduction to Pharmaceutical Medicine
- Pre-clinical Development of Drugs and Biologics
- Clinical Phases of Drug development
- General Pharmacology
- BA-BE Studies
- Pharmacogenetics-Pharmacogenomics
- Toxicology
- Systemic Pharmacology
- Clinical Trial Design
- Intellectual Property Rights
- Personalized Medicine
- Clinical Trials in Pediatrics
- Drug Safety in Pregnancy
- Research Methods for Genetics Studies
- Stem Cell Research and its Applications
- Endpoints in Clinical Trials
- Clinical Trial Registries
Module 4 – Basics of Good Medical Writing
- Introduction & Scope of Medical Writing
- Good Versus Poor Scientific Writing – An Orientation
- Statistics in Medical Writing
Module 5 – Computer Skills
- MS Word, Excel & Other Open Source Software
- Effective Internet Literature Search
Module 6 – Overview of the Regulatory, Marketing and Drug Promotion Process
- Introduction to Regulatory Medical Writing
- Investigation New Drug & Investigational Device Exemption Application
- Protocols, Amendments & Study Reports
- Investigator Brochure & Product Labels
- NDA’s, BLA’s & PMA’s
- Annual Reports
- Product Labeling
- Abstracts & Posters for Scientific Meetings
- Manuscripts for Publication in Scientific Journals
- Legal-Copyright-IP Issues in Medical writing
Module 7 – Common Technical Document
- Introduction and overview of CTD and eCTD
- Putting it all together – CTD Module 1
- Putting it all together – Producing the CTD Modules
- Multi-region submissions & submission standards
- Interfacing with regulatory agencies and answering queries
- Aggregate safety reports
Module 8 – Protocol, Investigator’s Brochure and Case Report Forms
- Writing clinical study protocols
- Introduction to writing Investigator Brochure’s
- Writing case report forms
- Writing regulatory compliant informed consent forms
- ICSR – Patient Narratives
Module 9 – Clinical Study Report
- Parts of a Clinical Study Report
- Templates & Boilerplate Text
- Tips on writing each section of the CSR
Module 10 – Sentence Control
- Fundamentals of Sentence Construction
- Controlling Voice of Sentence for Readability
- Correct Punctuation
- Consistency in Tense Use
- Imprecise Words and Phrases
- Word Order and Pronouns
- Subject – Verb Agreement
Module 11 – Writing Flow and Cohesiveness
- Writing Effective Paragraphs
- Using Effective Data Displays
- Using Style Guides for Consistent Medical Writing
- Overcoming Writers Block
Module 12 – Publication Writing
- Structure of a Scientific Paper
- Electronic Submissions
- Abstract for Scientific Meeting
- Case Report
- Review
- Ethics of Publication
- Guidelines of Publication (e.g. CONSORT, ICMJE, GPP)
- Referencing Guidelines & Taking Software’s Help
Module 13 – Documents in Medico-Marketing
- Leave behind literature (LBL), Visual Aids and Brochure’s
- Continuing Medical Education (CME) for Doctors
- Evidence Based Medicine
- MR Training Manual
- Web Content, Audio-Visual Aids, CDs
Module 14 – Managing the Review Process
- Effective Review Practices
- Managing Incongruous Comments from Reviewers & Reaching Concurrence
- Process Flow and Metrics for Managing Regulatory Submissions
Course Completion
- Final Assessment
- Course Certification
Certification
At the end of the course, students will be awarded a certificate of completion.
Duration
The duration of this program is 3 months.
You will have access to the course on the learning portal, for the duration of the program.
John ONeill (verified owner) –
I learned a tremendous amount from this certificate and will probably do more CLINSKILL training. Nitin in customer support was terrific. I give it four stars instead of five because some (a small minority) of the lessons weren’t as good as the majority. Even so, I’d recommend it to anyone else who’s interested. John O’Neill
Tahir Bhasin –
Detailed program that covered all the aspects of Medical Writing as applies to the pharmaceutical industry.