Introduction to Clinical Data Management (TTC KW A02)
Introduction to Clinical Data Management (TTC KW A02)
- Summaries, examples, and practical checklists
- Access on mobile & desktop
- Duration time: 8 hours
- Certificate of completion
- 6 months access
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Introduction to Clinical Data Management (Module TTC KW A02)
This course is designed for aspiring and early-career professionals who want a clear, practical introduction to Clinical Data Management (CDM)—one of the most critical functions in clinical research and drug development. Whether you’re new to clinical trials, transitioning from another role, or strengthening your fundamentals, you’ll learn how clinical data is collected, cleaned, managed, and delivered across a trial.
Clinical data forms the evidence behind safety decisions, regulatory submissions, and statistical conclusions. In this course, you’ll understand how CDM fits into the broader clinical development process and why patient safety and data integrity must guide every decision. You’ll leave with a practical framework and the language used in real clinical trial teams.
Why TriTiCon
TriTiCon training is built from real clinical trial experience—designed for how work actually happens in pharma, biotech, and CRO environments. Instead of academic theory, you get an industry-aligned process view that connects roles, stakeholders, and deliverables across the trial lifecycle.
You’ll learn how CDM collaborates with clinical operations, medical, safety, statistics, and regulatory functions—so you can understand expectations, contribute effectively, and communicate with confidence. Complex topics like data cleaning, protocol deviations, and database lock are explained in a structured, approachable way without oversimplifying the responsibility of the role.
If you’re looking for clinical data management training that’s practical, credible, and directly relevant to modern clinical research, this module provides a strong foundation.
1
What Is Clinical Data Management?
- How CDM fits into clinical development and the clinical trial lifecycle
- What "clinical data" is and why it matters for evidence-based decisions
- Key stakeholders and cross-functional interactions
- Core principles: patient safety and data integrity
- Introduction to ALCOA+ and trustworthiness of clinical data
2
The CDM Process (Collect, Clean, Consolidate)
- Data collection channels: EDC/eCRF, labs, imaging/ECG, PRO/COA, and emerging sources (e.g., wearables)
- Data cleaning: programmed checks, manual review, analytics, and the query process
- Proactive data quality fundamentals: protocol quality, training, and site-focused system setup
- Protocol deviations: types, why they matter, and how CDM supports identification and handling
- Data consolidation: integrating data sources, standardization, and medical coding concepts
- Database lock: clean file readiness, collaboration, and final data delivery
3
Managing Clinical Data Management
- Planning and setup: vendors, systems, integrations, and data flows
- Oversight during conduct: monitoring, coordination, risk handling
- Key milestones and deliverables (e.g., DMP, specifications, test documentation)
- Documentation expectations in regulated environme
Anders Mortin
Clinical Data Management Expert
TriTiCon delivers clinical data management training based on extensive hands-on experience from real clinical trials across sponsors, CROs, and life sciences organizations. The training is developed by industry professionals who work directly with clinical data, systems, documentation, and cross-functional trial teams.
Who is this course for?
This course is designed for aspiring and early-career professionals who want a practical introduction to Clinical Data Management. It's ideal for those new to clinical trials, transitioning from another role, or strengthening their CDM fundamentals.
Do I need prior clinical trial experience?
No formal prerequisites are required. A basic understanding of clinical trials is beneficial. If you are new to clinical research, completing Module A01 – Introduction to Clinical Development and Clinical Data is recommended.
How long does the course take?
Estimated learning time is approximately 6–10 hours, depending on your pace and background.
Is it self-paced?
Yes! Once enrolled, you can access all course materials at any time and progress at your own pace. There are no deadlines or live sessions required.
Do I receive a certificate?
Yes! Upon completing all chapters and passing the certification test, you'll receive a certificate of completion. Note: The certificate supports professional development but is not a license or regulatory credential.
How is this different from other CDM courses?
TriTiCon training is built from real clinical trial experience—designed for how work actually happens in pharma, biotech, and CRO environments. Instead of academic theory, you get an industry-aligned process view that connects roles, stakeholders, and deliverables across the trial lifecycle.
What career outcomes does this support?
Yes! This course builds the CDM fundamentals employers expect: understanding collection channels, data quality workflows, protocol deviations, documentation, and database lock readiness. It supports learners aiming for roles such as Clinical Data Manager, CRA, Clinical Trial Assistant, and other clinical-operations positions.
Description
Introduction to Clinical Data Management (Module TTC KW A02)
This course is designed for aspiring and early-career professionals who want a clear, practical introduction to Clinical Data Management (CDM)—one of the most critical functions in clinical research and drug development. Whether you’re new to clinical trials, transitioning from another role, or strengthening your fundamentals, you’ll learn how clinical data is collected, cleaned, managed, and delivered across a trial.
Clinical data forms the evidence behind safety decisions, regulatory submissions, and statistical conclusions. In this course, you’ll understand how CDM fits into the broader clinical development process and why patient safety and data integrity must guide every decision. You’ll leave with a practical framework and the language used in real clinical trial teams.
Why TriTiCon
TriTiCon training is built from real clinical trial experience—designed for how work actually happens in pharma, biotech, and CRO environments. Instead of academic theory, you get an industry-aligned process view that connects roles, stakeholders, and deliverables across the trial lifecycle.
You’ll learn how CDM collaborates with clinical operations, medical, safety, statistics, and regulatory functions—so you can understand expectations, contribute effectively, and communicate with confidence. Complex topics like data cleaning, protocol deviations, and database lock are explained in a structured, approachable way without oversimplifying the responsibility of the role.
If you’re looking for clinical data management training that’s practical, credible, and directly relevant to modern clinical research, this module provides a strong foundation.
What You'll Learn
Curriculum
1
What Is Clinical Data Management?
- How CDM fits into clinical development and the clinical trial lifecycle
- What "clinical data" is and why it matters for evidence-based decisions
- Key stakeholders and cross-functional interactions
- Core principles: patient safety and data integrity
- Introduction to ALCOA+ and trustworthiness of clinical data
2
The CDM Process (Collect, Clean, Consolidate)
- Data collection channels: EDC/eCRF, labs, imaging/ECG, PRO/COA, and emerging sources (e.g., wearables)
- Data cleaning: programmed checks, manual review, analytics, and the query process
- Proactive data quality fundamentals: protocol quality, training, and site-focused system setup
- Protocol deviations: types, why they matter, and how CDM supports identification and handling
- Data consolidation: integrating data sources, standardization, and medical coding concepts
- Database lock: clean file readiness, collaboration, and final data delivery
3
Managing Clinical Data Management
- Planning and setup: vendors, systems, integrations, and data flows
- Oversight during conduct: monitoring, coordination, risk handling
- Key milestones and deliverables (e.g., DMP, specifications, test documentation)
- Documentation expectations in regulated environme
Instructor
Anders Mortin
Clinical Data Management Expert
TriTiCon delivers clinical data management training based on extensive hands-on experience from real clinical trials across sponsors, CROs, and life sciences organizations. The training is developed by industry professionals who work directly with clinical data, systems, documentation, and cross-functional trial teams.
FAQ
Who is this course for?
This course is designed for aspiring and early-career professionals who want a practical introduction to Clinical Data Management. It's ideal for those new to clinical trials, transitioning from another role, or strengthening their CDM fundamentals.
Do I need prior clinical trial experience?
No formal prerequisites are required. A basic understanding of clinical trials is beneficial. If you are new to clinical research, completing Module A01 – Introduction to Clinical Development and Clinical Data is recommended.
How long does the course take?
Estimated learning time is approximately 6–10 hours, depending on your pace and background.
Is it self-paced?
Yes! Once enrolled, you can access all course materials at any time and progress at your own pace. There are no deadlines or live sessions required.
Do I receive a certificate?
Yes! Upon completing all chapters and passing the certification test, you'll receive a certificate of completion. Note: The certificate supports professional development but is not a license or regulatory credential.
How is this different from other CDM courses?
TriTiCon training is built from real clinical trial experience—designed for how work actually happens in pharma, biotech, and CRO environments. Instead of academic theory, you get an industry-aligned process view that connects roles, stakeholders, and deliverables across the trial lifecycle.
What career outcomes does this support?
Yes! This course builds the CDM fundamentals employers expect: understanding collection channels, data quality workflows, protocol deviations, documentation, and database lock readiness. It supports learners aiming for roles such as Clinical Data Manager, CRA, Clinical Trial Assistant, and other clinical-operations positions.