Introduction to Clinical Development and Clinical Data (TTC KW A01)
Introduction to Clinical Development and Clinical Data (TTC KW A01)
- Summaries, examples, and practical checklists
- Access on mobile & desktop
- Certificate of completion
- 6 months access
- Duration time: 10 hours
After purchase, you'll receive an email with login credentials to Knowledge World, our learning platform where all course materials are hosted. You can start learning immediately!
Clinical Data Management Training for Modern Clinical Research (Module TTC KW A01)
This online Clinical Data Management (CDM) training course is built for learners who want a clear, practical introduction to how clinical trial data is planned, collected, reviewed, and turned into evidence. It’s ideal if you are starting out in clinical research, moving into a more data-focused role, or want to formalize your understanding of how CDM fits into clinical development.
The course is especially relevant for Clinical Trial Assistants (CTAs), Clinical Research Associates (CRAs), aspiring Clinical Data Managers, life science graduates, and professionals in clinical operations. You’ll learn the language, workflows, and responsibilities that sit behind high-quality clinical data—without getting lost in academic theory.
In clinical research, decisions on safety, efficacy, and regulatory approvals depend on data that is complete, consistent, and traceable. This course helps you understand why data integrity and structured processes matter, and how strong CDM fundamentals support patient safety and credible trial outcomes.
Why Learn with TriTiCon
TriTiCon is a specialized life sciences consulting and training company with hands-on experience across clinical trials, clinical data management, biometrics, regulatory interactions, and pharmacovigilance. Our training is created by industry professionals who work with clinical development programs and understand the real-world demands placed on teams in sponsors, CROs, and biotech organizations.
Instead of presenting CDM as abstract concepts, TriTiCon focuses on how clinical research actually works: the planning behind trial design, the operational reality of executing protocols, and the practical dependencies between teams, systems, vendors, and sites. You’ll see how clinical trials are managed as projects—where milestones, roles, and documentation aren’t optional, they’re part of everyday delivery.
TriTiCon’s approach emphasizes industry-aligned learning: the clinical development context, key decision points, and the regulatory expectations that shape data handling and documentation. This means you build knowledge you can recognize and apply in real discussions—whether you work in study support, monitoring, or data management.
If you’re comparing clinical research courses, this course stands out by being structured, practical, and designed to help learners build usable CDM fundamentals—not just definitions.
CDM Focus Areas You Will Be Able to Explain Confidently
- Data cleaning and review: what “clean data” means, why review is continuous, and how issues are handled
- Data consolidation: how multiple sources align into a usable clinical database for analysis
- Database lock (DBL): why it’s a critical milestone and what must be true before locking
- Patient safety: how safety data (including adverse events) connects to oversight and documentation
- Data integrity: principles such as ALCOA+ and why traceability and accuracy matter
- Protocol deviations: what they are, how they can affect data quality, and why documentation matters
1
Clinical Development Context and Why Data Matters
- What clinical development is and how clinical trials contribute evidence for safety and efficacy
- How trials are structured in phases and why timelines, costs, and attrition shape decision-making
- Why clinical data is central to development programs, submissions, and trust in results
- High-level view of rules and guidance (e.g., ethical foundations and Good Clinical Practice)
2
Trial Design, Data Scope, and Data Collection
- Design basics: hypothesis, endpoints, and how "starting with the end in mind" drives data needs
- Trial schedules/flowcharts and how they map visits, procedures, and required data
- Clinical data collection in practice: structured capture into a clinical database (often via EDC)
- How different data sources come together (site-entered data, labs, devices, and integrations)
3
Executing a Trial and Managing Data-Driven Processes
- The protocol as the operational plan: linking scientific design to practical execution
- Trial stages and milestones (from start-up and conduct through close-out and reporting)
- Roles and stakeholders: sponsor accountability, sites/investigators, vendors, and cross-functional teams
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 ideal for Clinical Trial Assistants (CTAs), Clinical Research Associates (CRAs), aspiring Clinical Data Managers, life science graduates, and professionals in clinical operations who want a practical introduction to clinical development and data management.
Do I need prior clinical trial experience?
No prior CDM experience is required. Basic familiarity with clinical research is helpful but not necessary—this course is designed as a foundation for those starting out.
How long does the course take?
Estimated learning time is approximately 8–12 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 the course content 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 credentia
How is this different from other CDM courses?
TriTiCon focuses on how clinical research actually works—the planning behind trial design, the operational reality of executing protocols, and the practical dependencies between teams, systems, vendors, and sites. You build knowledge you can recognize and apply in real discussions.
What career outcomes does this support?
Yes! This course supports learners aiming for roles such as Clinical Data Manager, CRA, Clinical Trial Assistant, and Clinical Operations positions. It helps you connect trial design and execution to data workflows and responsibilities.
Description
Clinical Data Management Training for Modern Clinical Research (Module TTC KW A01)
This online Clinical Data Management (CDM) training course is built for learners who want a clear, practical introduction to how clinical trial data is planned, collected, reviewed, and turned into evidence. It’s ideal if you are starting out in clinical research, moving into a more data-focused role, or want to formalize your understanding of how CDM fits into clinical development.
The course is especially relevant for Clinical Trial Assistants (CTAs), Clinical Research Associates (CRAs), aspiring Clinical Data Managers, life science graduates, and professionals in clinical operations. You’ll learn the language, workflows, and responsibilities that sit behind high-quality clinical data—without getting lost in academic theory.
In clinical research, decisions on safety, efficacy, and regulatory approvals depend on data that is complete, consistent, and traceable. This course helps you understand why data integrity and structured processes matter, and how strong CDM fundamentals support patient safety and credible trial outcomes.
Why Learn with TriTiCon
TriTiCon is a specialized life sciences consulting and training company with hands-on experience across clinical trials, clinical data management, biometrics, regulatory interactions, and pharmacovigilance. Our training is created by industry professionals who work with clinical development programs and understand the real-world demands placed on teams in sponsors, CROs, and biotech organizations.
Instead of presenting CDM as abstract concepts, TriTiCon focuses on how clinical research actually works: the planning behind trial design, the operational reality of executing protocols, and the practical dependencies between teams, systems, vendors, and sites. You’ll see how clinical trials are managed as projects—where milestones, roles, and documentation aren’t optional, they’re part of everyday delivery.
TriTiCon’s approach emphasizes industry-aligned learning: the clinical development context, key decision points, and the regulatory expectations that shape data handling and documentation. This means you build knowledge you can recognize and apply in real discussions—whether you work in study support, monitoring, or data management.
If you’re comparing clinical research courses, this course stands out by being structured, practical, and designed to help learners build usable CDM fundamentals—not just definitions.
CDM Focus Areas You Will Be Able to Explain Confidently
- Data cleaning and review: what “clean data” means, why review is continuous, and how issues are handled
- Data consolidation: how multiple sources align into a usable clinical database for analysis
- Database lock (DBL): why it’s a critical milestone and what must be true before locking
- Patient safety: how safety data (including adverse events) connects to oversight and documentation
- Data integrity: principles such as ALCOA+ and why traceability and accuracy matter
- Protocol deviations: what they are, how they can affect data quality, and why documentation matters
What You'll Learn
Curriculum
1
Clinical Development Context and Why Data Matters
- What clinical development is and how clinical trials contribute evidence for safety and efficacy
- How trials are structured in phases and why timelines, costs, and attrition shape decision-making
- Why clinical data is central to development programs, submissions, and trust in results
- High-level view of rules and guidance (e.g., ethical foundations and Good Clinical Practice)
2
Trial Design, Data Scope, and Data Collection
- Design basics: hypothesis, endpoints, and how "starting with the end in mind" drives data needs
- Trial schedules/flowcharts and how they map visits, procedures, and required data
- Clinical data collection in practice: structured capture into a clinical database (often via EDC)
- How different data sources come together (site-entered data, labs, devices, and integrations)
3
Executing a Trial and Managing Data-Driven Processes
- The protocol as the operational plan: linking scientific design to practical execution
- Trial stages and milestones (from start-up and conduct through close-out and reporting)
- Roles and stakeholders: sponsor accountability, sites/investigators, vendors, and cross-functional teams
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 ideal for Clinical Trial Assistants (CTAs), Clinical Research Associates (CRAs), aspiring Clinical Data Managers, life science graduates, and professionals in clinical operations who want a practical introduction to clinical development and data management.
Do I need prior clinical trial experience?
No prior CDM experience is required. Basic familiarity with clinical research is helpful but not necessary—this course is designed as a foundation for those starting out.
How long does the course take?
Estimated learning time is approximately 8–12 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 the course content 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 credentia
How is this different from other CDM courses?
TriTiCon focuses on how clinical research actually works—the planning behind trial design, the operational reality of executing protocols, and the practical dependencies between teams, systems, vendors, and sites. You build knowledge you can recognize and apply in real discussions.
What career outcomes does this support?
Yes! This course supports learners aiming for roles such as Clinical Data Manager, CRA, Clinical Trial Assistant, and Clinical Operations positions. It helps you connect trial design and execution to data workflows and responsibilities.