The Clinical Data Management Set-up Process (TTC KW A03)
The Clinical Data Management Set-up Process (TTC KW A03)
- 8 hours of video content
- Summaries, examples, and practical checklists
- Access on mobile & desktop
- Certificate of completion
- 6 months access
- Duration time: 8 hours
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Clinical Data Management Set-Up Process (TTC KW A03)
Module A03 is designed for professionals who want a practical, step-by-step understanding of how clinical data management (CDM) is set up before a trial can collect data. It is ideal for beginners to early-career learners in clinical research, as well as CTAs, CRAs, aspiring Clinical Data Managers, and study team members who collaborate with vendors and systems during study start-up.
In this module, you will learn what must be in place to start clinical data collection—from the clinical technology landscape and the specify–build–test cycle, to essential documentation like the Data Management Plan (DMP), and the key deliverables that support inspection readiness. You will also learn what drives timelines and how teams can reduce avoidable delays through better standardization and decision-making.
Strong CDM set-up is critical in clinical research because it directly affects patient safety oversight, data integrity, and the reliability of trial evidence. If set-up is rushed or unclear, issues become costly and difficult to correct later—often impacting data quality, team workload, and milestone timelines.
Why Learn with TriTiCon
TriTiCon delivers industry-focused clinical data management training built on real-world experience across clinical trials, life sciences operations, and clinical data systems. Rather than teaching CDM as abstract theory, TriTiCon emphasizes how trial teams actually work: cross-functional collaboration, vendor oversight, practical documentation, and the decision points that determine whether a set-up is efficient, feasible, and compliant.
In Module A03, this practical focus matters. Trial set-up is not just “configuring a system.” It involves aligning protocol needs with data collection tools, defining how data will flow between systems, ensuring that stakeholders can use the solution in real-life site conditions, and documenting evidence that systems are tested, validated, and released correctly.
TriTiCon’s approach helps learners understand the “why” behind each set-up activity—so you can participate confidently in real start-up discussions, challenge unclear requirements, and recognize common traps (like over-engineering eCRFs, repeating technical testing during UAT, or allowing review cycles to create unnecessary idle time).
If you are comparing clinical research courses, TriTiCon’s advantage is that the learning is designed to be job-relevant: clear frameworks, practical checklists, and industry-aligned expectations you can recognize and apply in sponsor, CRO, and biotech environments.
What You’ll Learn
Module A03 focuses on the CDM set-up stage: the work required to prepare systems, documentation, and timelines so data collection can start smoothly and remain traceable and compliant throughout the study. You will connect CDM fundamentals to real start-up execution and understand how set-up decisions affect downstream data cleaning, consolidation, and database lock.
1
Clinical Technology Landscape and the Set-Up Process
- Technology landscape basics: Why clinical data involves multiple systems (EDC/eCRF, labs, ePRO/eCOA, ECG, imaging, wearables)
- Data flows and integrations: Interchanges, transfers, and system-to-system impacts on reconciliation
- Set-up lifecycle: The specify–build–test cycle in practice
- eCRF set-up fundamentals: Mirroring protocol while maintaining site workflow feasibility
- Key eCRF design principles: Invest time early, stick to protocol, lean on standards, keep it simple
- Testing approach: Technical testing vs User Acceptance Testing (UAT)
2
Data Management Plan and Set-Up Outputs
- The Data Management Plan (DMP): Purpose, content, and clarifying "who does what"
- Critical data and risk focus: Prioritizing patient safety, trial integrity, and endpoint data
- Minimum go-live checklist: Specifications, test documentation, release approval, change control, training records, manuals, helpdesk readiness, vendor contracts, validated systems, signed DMP
3
Typical Timelines and Timeline Drivers
- Typical set-up timelines: Industry benchmarks for eCRF, ePRO, labs/ECG/imaging, and data transfers
- Common timeline drivers: Unclear protocol requirements, slow review cycles, lack of standardization, late changes
- How to improve timelines: Clear decision-making, standards, interactive reviews, focused workshops
- Connection to CDM fundamentals: How set-up enables reliable data collection, reduces downstream cleaning, and supports database lock
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 module is ideal for beginners to early-career learners in clinical research, including CTAs, CRAs, aspiring Clinical Data Managers, and study team members involved in study start-up and vendor collaboration.
Do I need prior clinical trial experience?
Basic clinical trial understanding is helpful but not required. If you are completely new to clinical research, starting with an introductory module on clinical development is recommended.
How long does the course take?
Estimated learning time is approximately 6–10 hours, depending on your pace and note-taking preferences.
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 emphasizes job-relevant understanding and practical workflows. You'll learn the "why" behind set-up activities so you can participate confidently in real start-up discussions and recognize common traps like over-engineering eCRFs or allowing review cycles to create unnecessary delays.
What career outcomes does this support?
This module strengthens understanding for roles including Clinical Data Manager, CRA, Clinical Trial Assistant, Clinical Operations, and Study Start-Up positions. The knowledge helps you speak the language of set-up: specify–build–test, UAT, DMP expectations, and timeline drivers.
Description
Clinical Data Management Set-Up Process (TTC KW A03)
Module A03 is designed for professionals who want a practical, step-by-step understanding of how clinical data management (CDM) is set up before a trial can collect data. It is ideal for beginners to early-career learners in clinical research, as well as CTAs, CRAs, aspiring Clinical Data Managers, and study team members who collaborate with vendors and systems during study start-up.
In this module, you will learn what must be in place to start clinical data collection—from the clinical technology landscape and the specify–build–test cycle, to essential documentation like the Data Management Plan (DMP), and the key deliverables that support inspection readiness. You will also learn what drives timelines and how teams can reduce avoidable delays through better standardization and decision-making.
Strong CDM set-up is critical in clinical research because it directly affects patient safety oversight, data integrity, and the reliability of trial evidence. If set-up is rushed or unclear, issues become costly and difficult to correct later—often impacting data quality, team workload, and milestone timelines.
Why Learn with TriTiCon
TriTiCon delivers industry-focused clinical data management training built on real-world experience across clinical trials, life sciences operations, and clinical data systems. Rather than teaching CDM as abstract theory, TriTiCon emphasizes how trial teams actually work: cross-functional collaboration, vendor oversight, practical documentation, and the decision points that determine whether a set-up is efficient, feasible, and compliant.
In Module A03, this practical focus matters. Trial set-up is not just “configuring a system.” It involves aligning protocol needs with data collection tools, defining how data will flow between systems, ensuring that stakeholders can use the solution in real-life site conditions, and documenting evidence that systems are tested, validated, and released correctly.
TriTiCon’s approach helps learners understand the “why” behind each set-up activity—so you can participate confidently in real start-up discussions, challenge unclear requirements, and recognize common traps (like over-engineering eCRFs, repeating technical testing during UAT, or allowing review cycles to create unnecessary idle time).
If you are comparing clinical research courses, TriTiCon’s advantage is that the learning is designed to be job-relevant: clear frameworks, practical checklists, and industry-aligned expectations you can recognize and apply in sponsor, CRO, and biotech environments.
What You’ll Learn
Module A03 focuses on the CDM set-up stage: the work required to prepare systems, documentation, and timelines so data collection can start smoothly and remain traceable and compliant throughout the study. You will connect CDM fundamentals to real start-up execution and understand how set-up decisions affect downstream data cleaning, consolidation, and database lock.
What You'll Learn
Curriculum
1
Clinical Technology Landscape and the Set-Up Process
- Technology landscape basics: Why clinical data involves multiple systems (EDC/eCRF, labs, ePRO/eCOA, ECG, imaging, wearables)
- Data flows and integrations: Interchanges, transfers, and system-to-system impacts on reconciliation
- Set-up lifecycle: The specify–build–test cycle in practice
- eCRF set-up fundamentals: Mirroring protocol while maintaining site workflow feasibility
- Key eCRF design principles: Invest time early, stick to protocol, lean on standards, keep it simple
- Testing approach: Technical testing vs User Acceptance Testing (UAT)
2
Data Management Plan and Set-Up Outputs
- The Data Management Plan (DMP): Purpose, content, and clarifying "who does what"
- Critical data and risk focus: Prioritizing patient safety, trial integrity, and endpoint data
- Minimum go-live checklist: Specifications, test documentation, release approval, change control, training records, manuals, helpdesk readiness, vendor contracts, validated systems, signed DMP
3
Typical Timelines and Timeline Drivers
- Typical set-up timelines: Industry benchmarks for eCRF, ePRO, labs/ECG/imaging, and data transfers
- Common timeline drivers: Unclear protocol requirements, slow review cycles, lack of standardization, late changes
- How to improve timelines: Clear decision-making, standards, interactive reviews, focused workshops
- Connection to CDM fundamentals: How set-up enables reliable data collection, reduces downstream cleaning, and supports database lock
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 module is ideal for beginners to early-career learners in clinical research, including CTAs, CRAs, aspiring Clinical Data Managers, and study team members involved in study start-up and vendor collaboration.
Do I need prior clinical trial experience?
Basic clinical trial understanding is helpful but not required. If you are completely new to clinical research, starting with an introductory module on clinical development is recommended.
How long does the course take?
Estimated learning time is approximately 6–10 hours, depending on your pace and note-taking preferences.
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 emphasizes job-relevant understanding and practical workflows. You'll learn the "why" behind set-up activities so you can participate confidently in real start-up discussions and recognize common traps like over-engineering eCRFs or allowing review cycles to create unnecessary delays.
What career outcomes does this support?
This module strengthens understanding for roles including Clinical Data Manager, CRA, Clinical Trial Assistant, Clinical Operations, and Study Start-Up positions. The knowledge helps you speak the language of set-up: specify–build–test, UAT, DMP expectations, and timeline drivers.