Diploma in Clinical Research & Medical Writing

Categories: Advanced Programs
Includes 180 days access

Course Overview

Course Summary

The Advanced Diploma in Clinical Research & Medical Writing (ADCR-MW) is designed to provide you a complete understanding of the core areas of clinical research and medical writing. It equips you to start a career in Clinical Research Operations or as a Medical Writer. The course is aligned to the requirements of the industry provides comprehensive knowledge of all aspects of the curriculum.

Key Features

  • 24×7 access to the Oracle Siebel Clinical software.
  • Full access to e-Learning Portal containing Multimedia Tutorials and Quizzes.
  • Course Instructor support via Discussion Forums

Curriculum

  • Module 1 – General Introduction
  • Module 2 – Epidemiology and Evidence Based Medicine
  • Module 3 – Pharmaceutical Medicine
  • Module 4 – Therapeutic Areas
  • Module 5 – Ethics in Clinical Research
  • Module 6 – Roles and Responsibilities
  • Module 7 – Clinical Trial Preparation
  • Module 8 – Essential Documents and Regulatory Submission
  • Module 9 – Study Start-up
  • Module 10 – Clinical Trial Monitoring
  • Module 11 – Compliance and Audits
  • Module 12 – Data Management and Biostatistics
  • Module 13 – Regulatory Affairs in Clinical Research
  • Module 14 – Medical Device Trials
  • Module 15 – Project and Vendor Management
  • Module 16 – Financial Management of Clinical Trials
  • Module 17 – Personality Development and Communication Skills
  • Module 18 – Oracle Siebel Clinical CTMS
  • Module 19 – Basics of Good Medical Writing
  • Module 20 – Computer Skills
  • Module 21 – Overview of Regulatory, Marketing and Drug Promotion Process
  • Module 22 – Common Technical Document
  • Module 23 – Protocol, Investigator’s Brochure and CRFs
  • Module 24 – Clinical Study Report
  • Module 25 – Sentence Control
  • Module 26 – Writing Flow and Cohesiveness
  • Module 27 – Publication Writing
  • Module 28 – Documents in Medico-Marketing
  • Module 29 – Managing the Review Process
  • Course Completion

Certification

At the end of the course, students will be awarded a certificate of completion.

Duration:   6 months

Fees:  INR 49,999  (USD 899)

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