Diploma in Clinical Research & Data Management

$999.00

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

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Description

 

The Advanced Diploma in Clinical Research & Data Management (ADCR-DM) is an e-learning program designed to provide students a complete understanding of clinical research and clinical data management processes. It equips you to start a career in Clinical Research Operations or as a Clinical Data Management professional. The course is delivered through our learning portal and is aligned to the requirements of the industry.

The Advanced Diploma in Clinical Research & Data Management course includes hands-on training modules on Oracle Siebel Clinical – CTMS for Clinical Research and Oracle Clinical – CDMS for Clinical Data Management which are enterprise applications used in the management of clinical trial data by most Fortune 500 pharmaceutical companies and contract research organizations,.

The course comprises 22 modules, 188 chapters, and 136 Quizzes and comprehensively covers all aspects of clinical research and clinical data management 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, clinical trial management or in the management of clinical data. This enables you to be develop multiple skills and be eligible for a wider set of opportunities.

On completing your enrolment for the program you will instantly get access to our online learning portal and the relevant software.

This course includes access to latest versions of Oracle Siebel Clinical CTMS and Oracle Clinical – version 5.4 software for hands on practical experience.

 

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 Clinical software
  • Course Instructor support via Discussion Forums

Curriculum

Course Stats – 22 Modules, 184 Chapters, 136 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 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

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 Oracle Clinical software for the duration of the program.

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