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Diploma in Clinical Data Management

(16 customer reviews)

$799.00

Includes 24×7 access to Oracle Clinical for hands-on practice.

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Description

The Diploma in Clinical Data Management is a comprehensive online program designed to build knowledge and practical skills across the clinical data management lifecycle. The program combines structured, self-paced learning with multimedia tutorials, recorded sessions, quizzes, assessments and hands-on experience using Oracle Clinical.

Covering 5 modules, 47 topics and 44 quizzes, the program begins with an introduction to clinical research before progressing to clinical data management principles, processes, documentation, regulatory standards and clinical data management systems.

You will explore key areas including data management planning, Case Report Form (CRF) design, clinical data acquisition, database design, data entry, data validation, query management, medical coding, database closure, audits, data migration and archival.

The program also includes dedicated practical training using Oracle Clinical, helping you connect clinical data management concepts and processes with their application in a clinical data management system.

Program at a Glance

5 Modules | 47 Topics | 44 Quizzes

3 Months | 24×7 Software Access | Certificate of Completion

What You’ll Learn

  • Clinical Data Management principles and processes
  • Data Management Plans and CDM documentation
  • Case Report Form (CRF) design and clinical data acquisition
  • Clinical database definition and design
  • Data entry, validation and quality control
  • Data validation and query management
  • Discrepancy and Data Clarification Form (DCF) management
  • Medical coding dictionaries and MedDRA
  • Clinical Data Management standards, SOPs and audits
  • Database closure, migration and archival
  • Clinical study setup and data management using Oracle Clinical

Who Is This Program For?

  • Students and graduates interested in Clinical Data Management
  • Life sciences, pharmacy, medical and healthcare graduates
  • Clinical research professionals exploring data management
  • Professionals transitioning into Clinical Data Management
  • Clinical Data Management professionals looking to strengthen their knowledge across key functional areas
  • Learners seeking hands-on exposure to clinical data management software

Hands-On Experience with Oracle Clinical

The program includes 24×7 access to Oracle Clinical for the duration of the program, allowing you to apply clinical data management concepts in a practical software environment.

Through dedicated software training, you will practice key clinical data management activities including clinical study planning and setup, CRF design, Global Library configuration, validation and derivation procedures, data entry, discrepancy management and Data Clarification Form (DCF) management.

This practical component helps you connect clinical data management processes with their application in a clinical data management system and develop hands-on familiarity with clinical data workflows.

New to Clinical Data Management? Explore our free learning resource on What is Clinical Data Management.

Explore more Clinical Data Management courses and training programs.

Key Features

  • Comprehensive Clinical Data Management curriculum covering key processes and systems
  • 5 modules, 47 topics and 44 quizzes
  • Multimedia tutorials and recorded sessions
  • 24×7 access to Oracle Clinical
  • Hands-on training in clinical data management activities
  • Quizzes and assessments to reinforce learning
  • Instructor support through discussion forums
  • Certificate of Completion

Curriculum

Module 1 – Introduction to Clinical Research
  • Pharmaceutical & Clinical Research – 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 – 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 3 – 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 4 – Clinical Data Management Systems
  • Clinical Data Management Systems
  • Database Migration and Archival
  • Medical Coding Dictionaries and MedDRA
  • Software Tools Used in Clinical Trial Management
  • Laboratory Data
  • Receipt and Review of Data
  • Data Presentation
  • Oracle Pharmaceutical Application Suite
Module 5 – 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

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

Duration

The program duration is 3 months, with flexible, self-paced access to the online learning portal.

You will also receive access to Oracle Clinical for the duration of the program, allowing you to practise alongside your learning.

16 reviews for Diploma in Clinical Data Management

  1. Nazia Khan (verified owner)

    Highly recommend this course. I did previously the same course CDM with others but understood only 10% but when I took course here, I completely understood how it works also had a great experience working in the software. The support team are so prompt in answering our queries. I am 100% satisfied and learnt a lot here. Its a great platform for all those who wants to start a career in CDM.

  2. Pinaki Roy

    Tried the cheaper programs at Udemy first. Those covered the bare basics of clinical data management. If you wish to seriously persue a career in clinical data management this is the course to go for. Covers the theoritical process, documentation and regulations in clinical data management and then covers the practical application including designing a study, creating CRFs, data entry, validation programming, discrepancy management etc using the Oracle Clinical software. The good part is you don’t just see, you can do the tasks yourself as you get access to the actual software used in the industry. I would definitely recommend this to professionals serious about making a career in clinical data management.

  3. Payal Rohtagi

    Comprehensive course. Recommend it!

  4. Lyna Mukherjee

    Easy to understand tutorials and instructor support via discussion forums was excellent. Content is authoritative.

  5. Matt Pretzel

    Very comprehensive course and included a module on Oracle Clinical which makes it practical and relevant to the industry.

  6. Gyanendra

    This course really helped me get a job. I was working as a CRA and wanted to take up a position that required less travel. The practical training on Oracle Clinical was very useful and made me eligible for many roles. I really worked hard with this course and it paid off. I would really recommend this course if you are serious about starting a career in the clinical data management domain.

  7. Ashley

    The course met my expectations and made me confident in performing data management tasks using Oracle Clinical. Most employers i reached out wanted hands-on experience with the software and this course gave me just that. I am glad to have persued this program. It opened up opportunities for many clinical data management roles for me.

  8. James McGill

    Worked well for me. Happy with the experience.

  9. Mansi Mehrotra (verified owner)

    I think it’s a great course… those who want to persue this course … I think clinskill is best for it..
    The course includes comprehensive training on all clinical Data Management concepts and also includes access to the Oracle Clinical modules. I think I am pretty confident in the Management of Clinical Data now and access to Oracle Clinical has helped me learn, practice and become proficient.

  10. Brenda Torris

    Covers the subject comprehensively. Will definitely recommend this program. Highlight of this program is that it does not only teach the theoretical aspects of managing clinical data but also demonstrates how the process is performed within Oracle Clinical.

  11. Prakash Badal

    Completed by B.Pharm. A friend recommended me this course. I did not have any knowledge of clinical research. Having completed this course i am confident of clinical research terminology, clinical data management processes and can design a CRF, perform data entry and manage discrepancies. Good decision to have taken this program!

  12. Ikuko Schdimt

    Was looking for a course in clinical data management. Chose this course as they promised to provide access to Oracle Clinical software for practice. True to their word, received an email with access credentials to Oracle Clinical, the moment i enrolled and paid for the course. Support helped me setup the application on my computer. Case Report Forms were provided in the learning portal to practice on. Very happy with my decision. Recommend it to others who may be in the same situation as me.

  13. Pankaj Gupta

    Recommend it!

  14. David

    Assumes you have no knowledge of clinical data management. Great resource for those getting started in this field.

  15. Swagata Misra

    Audio Tutorials are engaging! Covers in detail how to manage clinical trial data using Oracle Clinical software.

  16. Prerna Mukherjee

    Fantastic course that covers all aspects of Clinical Data Management and Oracle Clinical. Access to Oracle Clinical software was provided.

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