Clinical Data Management Professional Certification Course – Get a CDM Pro Certification

Clinical Data Management Professional Certification Program – CDM Professional Certification Course.

Self-learning program

A deep-dive, industry-aligned program covering every phase of clinical data management from study start-up to career readiness through 19 comprehensive sessions.

SELF LEARN AT YOUR OWN PACE | GET CERTIFIED | BECOME JOB READY

Clinical Data Management

In clinical research, Clinical Data Management (CDM) is a critical technique. From various clinical tests, high-quality, reliable, and statistically sound data can be generated using this technique. The data are analyzed and integrated at appropriate quality and cost after the collection of data from different clinical trials. During the conduct of clinical trials, the entry, verification, validation, and quality control of data gathered is encompassed in Clinical Data Management. Clinical Data Management is a crucial and relevant part of a clinical trial.

Why is Clinical Data Management Needed?

At least once during a researcher's research period, the researchers working in the field of clinical research, try their hands-on Clinical Data Management activities. On the whole, the ones responsible for collecting data from several medical research projects — pharmaceutical and clinical trials — are the Clinical Data Managers. Clinical Data Managers work collaboratively to ensure that the data is collected, managed, and reported securely, accurately, and clearly. Clinical data managers work for research universities, private companies, government organizations, and hospitals. They also work for large pharmaceutical companies.

Career Prospects of Clinical Data Management

Generally, to be a Clinical Data Associate, the minimum requirement is a Bachelor's degree in life sciences, computer science, or healthcare. One has to undergo training programmes to increase knowledge in healthcare information systems, computer technology, and record management, as this arena demands knowledge in both computer science and healthcare. Experienced candidates are preferred by most industries nowadays. Thus, gathering experience of 1 to 2 years in the healthcare industry, ideally in clinical data management, is necessary.

After completing the Clinical Data Management Professional Certification Program, candidates have employment opportunities as:

• CRO's & Pharma Companies
• Biotech MNCs
• IT Organizations supporting Clinical Research
• Medical Device Companies
• Various Government-led Departments & Much More

Clinical Data Management Professional Certification Program – Course Contents:

1. Introduction to CDM – What is CDM, Clinical Research Overview, Sources of Data, Importance of Data, Importance of CDM, Stakeholders in CDM
2. CDM Process Overview – CDM process overview, Initiation of CDM work in Clinical Trials, Various documents involved, Data Management Plan, Phases of CDM
3. DMP & Study Start-Up – DMP in detail, Start-Up in detail
4. CDM Phases – Conduct & Study Close-Out – Study Conduct in detail, Study Close-Out in detail
5. Introduction to Database – Basic data concepts, What is a Database, Types of Databases, Databases relevant to Clinical Trials and why
6. Database Designing & Access Controls – Database designing, Importance of access controls, HIPAA, 21 CFR Part 11
7. Database Lock & Unlock – Lock and unlocking of Database, Query management, Process of locking, Process of Database unlocking
8. CRF Designing – What is a CRF, Importance of CRF in Clinical Trials, CRF designing, Tools used to design CRF
9. Data Processing – Phases of data processing in CDM, Tools used in data processing (CDMS tools: Medidata Rave, Oracle Clinical etc.; EDC tools: Castor EDC, OpenClinica etc.), Importance of data processing
10. Hands-On Session on CRF Designing
11. Hands-On Data Set Session
12. Data Analysis and Reporting – Introduction, Latest trends of data analysis in business intelligence, Scope for CDM in data analysis
13. Discrepancy Management – Workflow of discrepancy management, Classification of discrepancies, Best practices in discrepancy management
14. Audit Trails and Traceability – Introduction and purpose of audit trail, Best practices and benefits of implementing audit trail, Legal and regulatory requirements for audit trail and traceability
15. Quality Analysis – Introduction and dimensions of data quality, Quality analysis techniques in CDM, Tools used to assess quality analysis (Medrio)
16. Software and Programming Knowledge Needed for CDM – Essential software used in CDM (Castor EDC, ePRO, eTMF etc.), Global standards and their importance in CDM, Programming languages in CDM
17. Hands-On Castor EDC Session
18. Applications of CDM in Pharma, Biotech and Healthcare
19. Job Opportunities and Career Prospects – Skills, qualifications and job roles in CDM, Career growth & trends in CDM, Industries hiring CDM professionals for various roles

Mode of Workshop of Clinical Data Management Professional Certification Program: Online Self Learning

Certification: All participants who attend the Clinical Data Management Professional Certification Program are eligible to get the Participation Certificate.

Who Can Enroll:

• Students pursuing their B.Sc / B.Tech / M.Sc / M.Tech who aspire to work in the clinical research field
• Fresh graduates looking to build a career in clinical data management
• Working professionals in clinical research seeking to upgrade their CDM knowledge and skills

FAQs on Clinical Data Management Professional Certification Program:

What Does Online Self Learning Course Mean?

You have the liberty to log in anytime and study the course at your own pace through the online self-learning course. However, to proceed to the next lesson, you must watch 90% of all the lessons, and only after clearing the evaluation test available at the end of the course can you avail a Hard Copy Certificate.

How to Activate the Clinical Data Management Professional Certification Program?

Add the course to your cart and purchase it to enroll for the course! The course activation email will be sent to you almost immediately after you enroll.

How to Unlock the Next Lesson of the Clinical Data Management Professional Certification Program?

To begin your next session, hit the Complete and Continue button at the top after completing a session. You will not be able to proceed to the next lesson without completing the current one. Ensure not to skip through!

What is the Course Completion Time Limit?

The course is valid for 30 Days from the date of activation. A 30-day course validity promotes disciplined learning by setting a deadline, reducing procrastination, and encouraging active engagement. Learners can study at their convenience on any device. It ensures up-to-date knowledge, efficient resource management, and higher completion rates, benefiting both learners and providers. Extensions are available for more flexibility. If you want to increase course validity, contact info@biotecnika.org or chat with our experts below.

How do I evaluate myself?

 Time to test all the knowledge you have gained. Take the test at the end of the course and evaluate yourself. Every Self Learning Course has a test at the end. 

How to get the Clinical Data Management Course hard copy certificate?

To avail, the hard copy certificate, Take the test at the end of the course. Clearing the test ( with a minimum of 40%) will earn you the certificate. The certificate will be sent to your doorstep. Now you know not to skip through the course.

Whom Do I Contact for Support?

Click on the Chat option or write to us at info@biotecnika.org or cst@biotecnika.org whenever you have any trouble. You can instantly get in touch with our team.