The Professional Diploma in Clinical Data Management (PDCDM) is an online eLearning course that covers the management raw clinical data generated in clinical trials. The course is aligned to the requirements of the industry and imparts practical knowledge on clinical data management processes, documentation and workflow so that you may kickstart a career in Clinical Data Management.
The course includes hands-on practical training on the Oracle Clinical software which is the de-facto standard for management of clinical data used by most Fortune 500 companies today.
The Diploma in Clinical Data Management program is made up of 5 modules, 47 topics and 44 Quizzes. It covers the overview of clinical research, clinical data management processes, regulations & standards and clinical data management systems.
The final module of the course covers the process of managing clinical data using the Oracle Clinical application. This module covers all the clinical data management tasks performed in Oracle Clinical including Planning & Designing a study, Designing eCRFs, Generating and testing Data entry screens, Programming Validation Procedures, Performing Data Entry as well as Discrepancy and DCF management.
On completing your enrolment for the Diploma in Clinical Data Management program you will instantly get access to our online learning portal and the Oracle Clinical software.
This course includes access to latest version of Oracle Clinical – version 5.4.0 for hands on practical experience.
Find more information about the field of Clinical Data Management – What is Clinical Data Management.
Course Stats – 5 Modules, 47 Chapters, 44 Quizzes
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 Management of Clinical Trials
- 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
- 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, and Oracle Clinical software for the duration of the program.