Diploma in Clinical Research & Medical Writing

$899.00

Oracle Siebel Clinical – software access is included.

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Description

 

The Advanced Diploma in Clinical Research & Medical Writing (ADCR-MW) is an e-learning program 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 and  includes hands-on training modules on Oracle Siebel Clinical – CTMS for Clinical Research and a comprehensive understand of the Pharmaceutical Medical writing process.

This course provides 24×7 access to the Oracle Siebel Clinical – CTMS for hands-on practical learning.

 

Key Features

 

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

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

Certification

 

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

Duration

 

The duration of this program is 6 months.

You will have access to the course, and Oracle Siebel Clinical software for the duration of the program.

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