Diploma in Clinical Research & Data Management

Curriculum

The program combines comprehensive clinical research training with specialized clinical data management learning and software training in Oracle Siebel Clinical and Oracle Clinical. The curriculum progresses from clinical research foundations through clinical trial operations and management before moving into clinical data management processes, systems and software 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 – Basics of Clinical Data Management

• Introduction to Clinical Data Management
• Application of Computers in Pharmaceutical Research & Development
• Data Management Plan
• Case Report Form Design
• Patient Registration
• Clinical Data Acquisition
• Clinical Data Definition and Database Design
• Training, Education, and Documentation Requirements
• Safety Data Management
• CDM Documentation Overview

Module 20 – Clinical Data Management Processes and Standards

• Data Entry Methods and Processes
• Database Validation and Standards
• Database Closure
• Clinical Data Management Audits
• Measuring Performance in CDM
• Data Validation and Query Management
• Process of Drug Development
• Clinical Data Management Process
• Standard Operating Procedures

Module 21 – Clinical Data Management Systems

• Clinical Data Management Systems
• Database Migration and Archival
• Medical Coding Dictionaries and MedDRA
• Software Tools used in Management of Clinical Trials
• Laboratory Data
• Receipt and Review of Data
• Data Presentation
• Oracle Pharmaceutical Application Suite

Module 22 – Oracle Clinical Fundamentals

• Oracle Clinical Navigation
• Oracle Clinical Overview
• Oracle Clinical – Planning a study
• Oracle Clinical – Designing a study
• Oracle Clinical – Global Library (DVGs, Questions, Question Groups)
• Oracle Clinical – Definition subsystem (DCMs, DCIs, Layouts)
• Oracle Clinical – Validation and Derivation Procedures
• Oracle Clinical – Data Entry
• Oracle Clinical – Discrepancy and DCF Management

Course Completion

• Final Assessment
• Course Certification