Diploma in Medical Writing

Build knowledge and practical understanding of scientific, clinical and regulatory medical writing through a comprehensive self-paced online program.

Learn the principles of effective scientific writing and explore clinical study documents, regulatory submissions, publication writing and scientific communications.

14 Modules | 85 Chapters | 86 Quizzes | 3 Months | Certificate on Completion

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Key Features

Here’s how you learn

Multimedia Tutorials

Structured multimedia tutorials and voice-over presentations for flexible, self-paced learning.

Quizzes and Assessments

Reinforce your understanding through quizzes and graded assessments throughout the program.

Discussion Forums

Ask questions and engage with course instructors through program discussion forums.

Certificate of Completion

Receive a ClinSkill Certificate of Completion upon successful completion of the program and final assessment.

Diploma in Medical Writing

Self-Paced eLearning | 3 Months | Certificate on Completion

Diploma in Medical Writing

eLearning

$499

3 months of program access
14 structured learning modules
Multimedia tutorials and voice-over presentations
Quizzes and graded assessments
Discussion forums
ClinSkill Certificate of Completion

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Curriculum

Here’s what you learn

Module 1 : Introduction to Clinical Research

This module will introduce you to the filed of Clinical Research. You will learn about the origin of Clinical Research and the various stakeholders. You will also learn about the core principles and the regulatory bodies that govern this field.

7 chapters.

Module 2 : Epidemiology and Evidence Based Medicine

This module will introduce you to the field of Epidemiology and Epidemiological study designs. You shall also learn the concept of Evidence based medicine.

5 chapters.

Module 3 : Pharmaceutical Medicine

This module will cover the various areas of Pharmaceutical medicine, including the process of pre-clinical development, clinical development, Toxicology, Study Designs, Intellectual property rights and Personalised medicine. The fields of Drug Safety, Genetic studies, Stem cell Research etc. shall also be discussed.

16 chapters.

Module 4 : Basics of Good Medical Writing

This module will introduce you to Medical writing and its scope in clinical research. You will also learn about the important elements of medical writing and Statistic in Medical writing.

3 chapters.

Module 5 : Computer Skills

This module will introduce you to Microsoft Word, Excel and Open Source software. It will also cover methodology for Effective Internet Literature search.

2 chapters.

Module 6 : Regulatory, Marketing and Drug Promotion

This module will introduce you to the regulatory writing process for various clinical study documentation such as INDA, Clinical Study Protocol, Study reports, Investigators brochures, annual reports, product labelling etc. It will also cover the concepts of medical writing for marketing and drug promotion.

10 chapters.

Module 7 : Common Technical Document

This module will cover the process of creating and submission of CTD modules and eCTD. It was also cover how to interface and answer queries raised by regulatory agencies post submission and generation of Aggregate reports.

6 chapters.

Module 8 : Protocol, Investigator's Brochure and CRFs

This module will cover the process of writing a study protocol, Investigators Brochure, Case Report Forms, Informed Consent Forms and Patient narratives.

5 chapters.

Module 9 : Clinical Study Report

This module will cover the Clinical study reports, its content, templates and tips on writing each section of the clinical study report.

3 chapters.

Module 10 : Sentence Control

This module will cover the fundamentals of sentence construction, punctuation, tenses, pronouns, verb agreements and other concepts of effective sentence control.

7 chapters.

Module 11 : Writing Flow and Cohesiveness

This module will cover writing effective paragraphs, using effective data displays, writing medical data consistently any overcoming writers block.

4 chapters.

Module 12 : Publication Writing

This module will cover the writing of a scientific paper, abstracts for scientific meetings, case reports and content for electronic submission. It will also talk about the ethics and guidelines of publication.

8 chapters.

Module 13 : Documents in Medico-Marketing

This module will cover the various documents used in Medico-Marketing, including web content, audio-visual aids and medical writing training manuals

5 chapters.

Module 14 : Managing the Review Process

This module will cover effective review processes in medical writing and the process flow and metrics for managing regulatory submissions.

3 chapters.

Course Completion

This course completion module, includes a Final Quiz that you will need to take to complete this course. The marks of the final quiz will be added to the marks of all other graded activities of this course. If your total score in the course is 75% and above, you will be able to see a Course completion certificate which you can then download.

Final Assessment.

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Jennifer Adams

Student

“The program was thorough. It covered all the aspects of medical writing. Each chapter had a quiz which helped me assess myself as i learnt. The tutorials had a voice-over that made it easier to listen and learn. The mobile app allowed me to take my quizzes and listen to the presentations while travelling. Had a great experience with this program. Highly recommended. “

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FAQ

Here are some questions we get asked often about this course

What is medical writing?

Medical writing involves communicating scientific, clinical and medical information clearly and accurately for different audiences and purposes. It can include clinical and regulatory documents, scientific publications, educational materials and medical communications.

How is the program delivered?

The program is delivered through self-paced online learning using multimedia tutorials, voice-over presentations, quizzes, assessments and other learning resources.

Will I receive a Certificate of Completion?

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

What does the Diploma in Medical Writing cover?

The program covers scientific writing principles, literature research, clinical and regulatory documents, CTD/eCTD, protocols, Investigator’s Brochures, Case Report Forms, Clinical Study Reports, publication writing, medico-marketing communications and document review.

How long do I have access to the program?

The Diploma in Medical Writing provides access to the online learning program for 3 months.

What career areas can Medical Writing training help me explore?

Medical Writing knowledge is relevant to areas including clinical and regulatory writing, scientific publications, medical communications, clinical research documentation and scientific content development. Specific roles and requirements vary by employer, experience, education and location.

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