Diploma in Clinical Research & Medical Writing

Curriculum

The program combines comprehensive clinical research training with specialized medical writing learning and structured software training in Oracle Siebel Clinical.

The curriculum progresses from clinical research foundations through clinical trial operations and management before moving into scientific, clinical, regulatory and publication writing.

Oracle Siebel Clinical training provides practical exposure to clinical trial management software as part of the Clinical Research component of the program.

 

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