Description
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.
Curriculum
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
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 3 months.
You will have access to the course, and Oracle Clinical software for the duration of the program.
Ronnie Holt –
Delivered all that was promised including access to Oracle Clinical. This is the only course you would need in data management as it covered both theoretical as well as practical aspects of managing clinical data using Oracle Clinical. Approve of this course!
Pamela Redmond –
This course provides a thorough understanding of data handling in clinical research, with practical insights into industry-standard tools and techniques through Oracle Clinical.
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.
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.
Payal Rohtagi –
Comprehensive course. Recommend it!
Lyna Mukherjee –
Easy to understand tutorials and instructor support via discussion forums was excellent. Content is authoritative.
Matt Pretzel –
Very comprehensive course and included a module on Oracle Clinical which makes it practical and relevant to the industry.
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.
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.
James McGill –
Worked well for me. Happy with the experience.
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.
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.
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!
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.
Pankaj Gupta –
Recommend it!
David –
Assumes you have no knowledge of clinical data management. Great resource for those getting started in this field.
Swagata Misra –
Audio Tutorials are engaging! Covers in detail how to manage clinical trial data using Oracle Clinical software.
Prerna Mukherjee –
Fantastic course that covers all aspects of Clinical Data Management and Oracle Clinical. Access to Oracle Clinical software was provided.