Diploma in Clinical Research & Medical Writing

Curriculum

Course Stats – 29 Modules, 200 Chapters, 156 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 – Therapeutic Areas

• Introduction to Health and Disease
• Endocrinology 1
• Endocrinology 2 (Diabetes)
• Cancer Biology
• Cardiovascular Medicine
• Respiratory Medicine
• Psychiatry
• Neurology
• Women’s Health
• Infectious Diseases
• Dermatology

Module 5 – Ethics in Clinical Research

• Ethics in Clinical Research
• Informed Consent Process
• International Conference for Harmonization
• Schedule-Y
• ICMR Guidelines

Module 6 – Roles and Responsibilities

• Investigator Responsibilities
• Sponsor-Vendor Responsibilities
• IRB Responsibilities
• Role of Clinical Research Personnel

Module 7 – Clinical Trial Preparation

• Clinical Study Protocol – Protocol Writing
• CRF Design

Module 8 – Essential Documents and Regulatory Submission

• Essential Documents
• IND Submission
• Clinical Study Report (CSR)
• NDA Submission

Module 9 – Study Start-up

• Study Feasibility and Site Selection
• Pre-Study Visit
• Site Initiation
• Informed Consent Process
• Subject Recruitment and Retention
• Trial Master File

Module 10 – Clinical Trials Monitoring

• Routine Site Monitoring
• CRF Review and Source Data Verification
• Drug Accountability
• Safety Reporting and Pharmacovigilance
• Site Close-out

Module 11 – Compliance and Audits

• Site Audit and Overview
• Sponsor Compliance and Audit
• Standard Operating Procedures (SOP) in Clinical Research
• Electronic Records and Signatures
• Conflict of Interest

Module 12 – Data Management and Biostatistics

• Data Management Overview
• Introduction to Biostatistics
• Data Analysis and Reporting

Module 13 – Regulatory Affairs in Clinical Research

• Regulatory Enviroment in the US
• Regulatory Environment in Europe
• Regulatory Environment in India

Module 14 – Medical Device Trials

• Medical Devices – Definition and Lifecycle
• Global Regulatory Strategy for Medical Devices
• Medical Device- Trial Design Considerations

Module 15 – Project and Vendor Management

• Fundamentals of Project Management
• Integrated Project Management
• Clinical Research Outsourcing – Vendor Selection
• Clinical Research Outsourcing – Vendor Management
• Clinical Trial Supplies

Module 16 – Financial Management of Clinical Trials

• Accounting for Managers
• Clinical Trial Budgeting
• Clinical Trials Marketing
• Indemnity and Compensation

Module 17 – Personality Development and Communication Skills

• Understanding Self
• Self-esteem
• Emotional Intelligence
• Attitude
• Leadership
• Interpersonal Relationships
• Group Dynamics and Team building
• Stress Management
• Performance Appraisal
• Time Management
• Conflict Management

Module 18 – Oracle Siebel Clinical CTMS

• Siebel Clinical – Application Overview
• Siebel Clinical – Business Solution Footprint
• Siebel Clinical for Clinical Trial Management
• Siebel Clinical Fundamentals
• Siebel Clinical Fundamentals – Session 1

Module 19 – Basics of Good Medical Writing

• Introduction & Scope of Medical Writing
• Good Versus Poor Scientific Writing – An Orientation
• Statistics in Medical Writing

Module 20 – Computer Skills

• MS Word, Excel & Other Open Source Software
• Effective Internet Literature Search

Module 21 – 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 22 – 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 23 – 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 24 – Clinical Study Report

• Parts of a Clinical Study Report
• Templates & Boilerplate Text
• Tips on writing each section of the CSR

Module 25 – 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 26 – Writing Flow and Cohesiveness

• Writing Effective Paragraphs
• Using Effective Data Displays
• Using Style Guides for Consistent Medical Writing
• Overcoming Writers Block

Module 27 – 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 28 – 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 29 – 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