The Clinical Data Management Conduct Process (TTC KW A04)
The Clinical Data Management Conduct Process (TTC KW A04)
- Summaries, examples, and practical checklists
- Access on mobile & desktop
- Certificate of completion
- Duration time: 8 hours
- 6 months access
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Clinical Data Management During Trial Conduct (TTC KW A04)
The Clinical Data Management During Trial Conduct course is designed for professionals who want to understand how clinical data is actively managed once a clinical trial is live and patients are enrolled. It is well suited for beginners to early-intermediate learners in clinical research, including Clinical Trial Assistants, Clinical Research Associates (CRAs), aspiring Clinical Data Managers, and professionals working in clinical operations or data-focused roles.
In this course, you will learn how clinical data is collected, reviewed, cleaned, and consolidated during the conduct phase of a trial. The focus is on the day-to-day processes that ensure data quality, patient safety oversight, and regulatory compliance while the study is ongoing.
Trial conduct is where most clinical data is generated and where issues, if not handled correctly, can escalate quickly. Strong Clinical Data Management (CDM) practices during this phase are essential to maintain data integrity, support timely decision-making, and ensure a smooth path toward database lock and analysis.
Why Learn with TriTiCon
TriTiCon delivers clinical data management training grounded in real-world experience from active clinical trials across sponsors, CROs, and life sciences organizations. The training is designed by professionals who work directly with clinical data, systems, and cross-functional trial teams.
In Module A04, this practical perspective is especially important. Managing data during trial conduct involves continuous review, prioritization, collaboration, and decision-making. These are skills that cannot be learned effectively through theory alone.
TriTiCon’s approach focuses on realistic workflows: how queries are generated and resolved, how ongoing data cleaning is balanced with trial timelines, how safety data is reviewed, and how protocol deviations and data issues are documented and managed. You will learn how CDM interacts with sites, CRAs, safety teams, and statisticians during the active life of a study.
Compared with generic clinical research courses, TriTiCon emphasizes job-relevant understanding and industry-aligned expectations, helping learners recognize real CDM activities, terminology, and responsibilities used in clinical research environments.
1
Clinical Data Collection During Trial Conduct
- How clinical data is generated at sites and by patients during trial visits
- Ongoing data entry into systems such as EDC/eCRF
- Understanding different data sources and their impact on data flow
- The role of CDM in monitoring completeness and timeliness of data
2
Data Cleaning and Review Processes
- What data cleaning means in practice during an active trial
- Query management: creation, communication, resolution, and closure
- Logical checks, consistency checks, and identification of outliers
- Balancing data quality with operational efficiency
3
Patient Safety and Ongoing Oversight
- How safety data is collected and reviewed during trial conduct
- The relationship between CDM, safety teams, and clinical operations
- Why timely and accurate safety data is critical for patient protection
- Managing discrepancies between safety and clinical data sources
4
Data Integrity, ALCOA+, and Compliance
- Applying ALCOA+ principles to data collected during trial conduct
- Ensuring data is attributable, legible, contemporaneous, original, and accurate
- Understanding audit trails and traceability during ongoing updates
- Managing changes and corrections in a controlled, documented way
5
Protocol Deviations and Data Consolidation
- Understanding what protocol deviations are and how they occur
- How deviations can affect data quality and analysis
- Documenting, reviewing, and tracking deviations from a CDM perspective
- Consolidating data from multiple sources into a coherent dataset
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 Clinical Trial Assistants, Clinical Research Associates (CRAs), aspiring Clinical Data Managers, and professionals working in clinical operations or data-focused roles. It is well suited for beginners to early-intermediate learners in clinical research.
Do I need prior clinical trial experience?
Basic understanding of clinical trials and CDM fundamentals is recommended but not required.
How long does the course take?
Approximately 6–10 hours, depending on your pace. The course is self-paced so you can learn at your own speed.
Is it self-paced?
Yes! The course is completely self-paced and online. Once enrolled, you can access all course materials at any time and progress at your own speed.
Do I receive a certificate?
Yes! A certificate can be issued as documentation of course completion and knowledge confirmation. To receive certification, you must complete the module and pass the certification test. Note: The certificate supports professional development but is not a license or regulatory qualification.
How is this different from other CDM courses?
TriTiCon emphasizes job-relevant understanding and industry-aligned expectations, helping learners recognize real CDM activities, terminology, and responsibilities used in clinical research environments. The focus is on realistic workflows and practical skills.
Can this course help me transition into clinical data management?
Yes! This module supports professionals working in or transitioning toward roles that involve active clinical trial execution and data oversight. The knowledge gained is relevant for Clinical Data Managers, CRAs, Clinical Trial Assistants, and Clinical Operations roles.
Description
Clinical Data Management During Trial Conduct (TTC KW A04)
The Clinical Data Management During Trial Conduct course is designed for professionals who want to understand how clinical data is actively managed once a clinical trial is live and patients are enrolled. It is well suited for beginners to early-intermediate learners in clinical research, including Clinical Trial Assistants, Clinical Research Associates (CRAs), aspiring Clinical Data Managers, and professionals working in clinical operations or data-focused roles.
In this course, you will learn how clinical data is collected, reviewed, cleaned, and consolidated during the conduct phase of a trial. The focus is on the day-to-day processes that ensure data quality, patient safety oversight, and regulatory compliance while the study is ongoing.
Trial conduct is where most clinical data is generated and where issues, if not handled correctly, can escalate quickly. Strong Clinical Data Management (CDM) practices during this phase are essential to maintain data integrity, support timely decision-making, and ensure a smooth path toward database lock and analysis.
Why Learn with TriTiCon
TriTiCon delivers clinical data management training grounded in real-world experience from active clinical trials across sponsors, CROs, and life sciences organizations. The training is designed by professionals who work directly with clinical data, systems, and cross-functional trial teams.
In Module A04, this practical perspective is especially important. Managing data during trial conduct involves continuous review, prioritization, collaboration, and decision-making. These are skills that cannot be learned effectively through theory alone.
TriTiCon’s approach focuses on realistic workflows: how queries are generated and resolved, how ongoing data cleaning is balanced with trial timelines, how safety data is reviewed, and how protocol deviations and data issues are documented and managed. You will learn how CDM interacts with sites, CRAs, safety teams, and statisticians during the active life of a study.
Compared with generic clinical research courses, TriTiCon emphasizes job-relevant understanding and industry-aligned expectations, helping learners recognize real CDM activities, terminology, and responsibilities used in clinical research environments.
What You'll Learn
Curriculum
1
Clinical Data Collection During Trial Conduct
- How clinical data is generated at sites and by patients during trial visits
- Ongoing data entry into systems such as EDC/eCRF
- Understanding different data sources and their impact on data flow
- The role of CDM in monitoring completeness and timeliness of data
2
Data Cleaning and Review Processes
- What data cleaning means in practice during an active trial
- Query management: creation, communication, resolution, and closure
- Logical checks, consistency checks, and identification of outliers
- Balancing data quality with operational efficiency
3
Patient Safety and Ongoing Oversight
- How safety data is collected and reviewed during trial conduct
- The relationship between CDM, safety teams, and clinical operations
- Why timely and accurate safety data is critical for patient protection
- Managing discrepancies between safety and clinical data sources
4
Data Integrity, ALCOA+, and Compliance
- Applying ALCOA+ principles to data collected during trial conduct
- Ensuring data is attributable, legible, contemporaneous, original, and accurate
- Understanding audit trails and traceability during ongoing updates
- Managing changes and corrections in a controlled, documented way
5
Protocol Deviations and Data Consolidation
- Understanding what protocol deviations are and how they occur
- How deviations can affect data quality and analysis
- Documenting, reviewing, and tracking deviations from a CDM perspective
- Consolidating data from multiple sources into a coherent dataset
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 Clinical Trial Assistants, Clinical Research Associates (CRAs), aspiring Clinical Data Managers, and professionals working in clinical operations or data-focused roles. It is well suited for beginners to early-intermediate learners in clinical research.
Do I need prior clinical trial experience?
Basic understanding of clinical trials and CDM fundamentals is recommended but not required.
How long does the course take?
Approximately 6–10 hours, depending on your pace. The course is self-paced so you can learn at your own speed.
Is it self-paced?
Yes! The course is completely self-paced and online. Once enrolled, you can access all course materials at any time and progress at your own speed.
Do I receive a certificate?
Yes! A certificate can be issued as documentation of course completion and knowledge confirmation. To receive certification, you must complete the module and pass the certification test. Note: The certificate supports professional development but is not a license or regulatory qualification.
How is this different from other CDM courses?
TriTiCon emphasizes job-relevant understanding and industry-aligned expectations, helping learners recognize real CDM activities, terminology, and responsibilities used in clinical research environments. The focus is on realistic workflows and practical skills.
Can this course help me transition into clinical data management?
Yes! This module supports professionals working in or transitioning toward roles that involve active clinical trial execution and data oversight. The knowledge gained is relevant for Clinical Data Managers, CRAs, Clinical Trial Assistants, and Clinical Operations roles.