Diploma in Clinical Research & Pharmacovigilance

$999.00

Oracle Siebel Clinical + Oracle Argus Safety – software access is included.

Category:

 

The Advanced Diploma in Clinical Research & Pharmacovigilance (ADCR-PV) is an e-learning program that covers the core areas of the Clinical research and Pharmacovigilance processes and equips you to start a career as a Clinical Research or Drug Safety professional. The course is delivered through our learning portal, is aligned to the requirements of the industry and imparts clinical research and pharmacovigilance process knowledge in a clear and concise manner so that you may kick-start a career in clinical research and pharmacovigilance.

The Advanced Diploma in Clinical Research & Pharmacovigilance course includes a module on Oracle Siebel Clinical which is the preferred Clinical Trial Management system (CTMS) used in the industry today as well as a module on Oracle Argus Safety which is the de-facto standard for managing pharmacovigilance data.

The course comprises 25 modules, 180 chapters, and 154 Quizzes and comprehensively covers all aspects of clinical research and pharmacovigilance thus making you eligible for both roles in the industry. At the end of this you can choose to explore a career in clinical research operations or in the management of drug safety data.

This course provides 24x7 access to the Oracle Siebel Clinical CTMS as well as Oracle Argus Safety software 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
  • 24×7 access to Oracle Argus Safety software
  • Course Instructor support via Discussion Forums

Curriculum

Course Stats – 25 Modules, 180 Chapters, 154 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 – 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

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, Oracle Siebel Clinical and Argus Safety software for the duration of the program.

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