Diploma in Clinical Research & Pharmacovigilance

Curriculum

The program combines comprehensive clinical research training with specialized pharmacovigilance learning and software training in Oracle Siebel Clinical and Oracle Argus Safety.

The curriculum progresses from clinical research foundations through clinical trial operations and management before moving into pharmacovigilance, drug safety processes and safety database applications.

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 – Principles of Pharmacovigilance

• General Overview of Pharmacovigilance
• History and aim of Pharmacovigilance
• Drug dependence
• Vaccine Vigilance
• Principles of Signal Detection in Pharmacovigilance
• Communication in Pharmacovigilance
• Post-Marketing Surveillance

Module 20 – Pharmacovigilance and Selected System Organ Classes

• Dermatological ADRs
• Gastrointestinal ADRs
• Haematological ADRs
• Renal ADRs
• Ocular Side Effects of Prescription Medications
• Drug Safety in Pregnancy
• Hepatic Drug Reactions
• Anaesthetic Adverse Drug Reactions
• Pharmacovigilance in Pediatrics
• The Cardiovascular Spectrum of Adverse Drug Reactions
• Drugs and the Elderly

Module 21 – Pharmacovigilance Systems

• Audits and Inspections in Pharmacovigilance
• Pharmacovigilance Department
• Qualified Person for Pharmacovigilance
• Standard Operating Procedures in Pharmacovigilance
• Literature Review
• MedDRA
• Eudravigilance
• Assessment of Compliance
• Mergers and Acquisitions
• Softwares used in Pharmacovigilance

Module 22 – Global Pharmacovigilance and Safety Standards

• WHO & Safety Reporting
• CIOMS Groups & Functions
• Good Pharmacovigilance Practice

Module 23 – Pharmacovigilance Regulations and Guidelines

• Safety Reporting
• Individual case safety reports
• Periodic safety update reports
• Indian Regulations with specific reference to Schedule Y
• Regulatory Pharmacovigilance in EU

Module 24 – Pharmacoepedemiology

• Introduction to Pharmacoepidemiology
• Molecular Genetic Pharmacoepidemiology
• Analysis of Pharmacoepidemiological Data
• Studies of Drug Use
• Case Control Studies
• Cohort Studies
• Data Sources
• Measures of Frequency & Risk
• Advanced Issues in Pharmacoepidemiology
• Errors in Pharmacoepidemiology

Module 25 – Oracle Argus Safety Essentials

• Overview and Navigation
• Overview of Argus Menus
• Case Form Features
• Drug and Event Coding
• Case Entry and Processing
• Advanced Conditions
• Reporting and Submissions

Course Completion

• Final Assessment
• Course Certification