Diploma in Clinical Research


Oracle Siebel Clinical – software access is optional.


The Post Graduate Diploma in Clinical Research (PGDCR) is an online eLearning course that covers the core areas of the clinical research process and equips you to start a career as a Clinical Research Professional. The course is aligned to the requirements of the industry and imparts clinical research process knowledge in a clear and concise manner so that you may kick-start a career in clinical research.

This course provides practical knowledge of the Oracle Siebel Clinical CTMS software used as a de-facto standard for managing clinical trial data.

The Diploma in Clinical Research program is made up of 18 modules, 143 topics and 100 Quizzes. It lays a strong foundation by covering the concepts of Epidemiology, Pharmaceutical medicine and Therapeutic Areas. This is followed by an Overview of Clinical Research, Ethics and Guidelines, Roles and Responsibilities as well as the processes that are a part of managing clinical trials.

The course covers in detail the process of clinical trial preparation, Study startup, Trial monitoring, Audits and Inspection and Regulatory documentation & Submission. It covers all components of clinical research including clinical trial management, clinical data management, regulatory affairs as well as Project & Financial management.

The final module of the course covers the process of managing clinical trial data using the Oracle Siebel Clinical application. This module covers all the clinical trial management tasks performed in Oracle Siebel Clinical including Site management, Visit Tracking, Budgeting, Protocol and CRF management and maintaining Drug Accountability.

On completing your enrolment for the Diploma in Clinical Research program you will instantly get access to our online learning portal.

Looking for a course that includes 24×7 access to Oracle Siebel Clinical software? Check out this course

Find more information about the field of Clinical Research – What is Clinical Research

Key Features


  • Full access to e-Learning Portal containing Multimedia Tutorials and Quizzes.
  • Course Instructor support via Discussion Forums


Course Stats – 18 Modules, 143 Chapters, 100 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
Course Completion
  • Final Assessment
  • Course Certification



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



The duration of this program is 3 months.

You will have access to the course for the duration of the program.


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