The Clinical Data Management Close-out Process (TTC KW A05)
The Clinical Data Management Close-out Process (TTC KW A05)
- Summaries, examples, and practical checklists
- Access on mobile & desktop
- Certificate of completion
- Duration time: 8 hours
- 6 months access
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The Clinical Data Management Close-out Process (TTC KW A05)
The Clinical Data Management Close-Out Process course is designed for professionals who want to understand how clinical data management activities are completed at the end of a clinical trial. It is suitable for beginners to intermediate learners in clinical research, including Clinical Trial Assistants, Clinical Research Associates (CRAs), aspiring Clinical Data Managers, and professionals working in clinical operations, biometrics, or data-focused roles.
In this course, you will learn how clinical data is finalized, verified, locked, delivered, archived, and formally closed out. The focus is on the critical final steps that ensure data is complete, reliable, traceable, and ready for analysis, regulatory review, and long-term retention.
The close-out phase is often referred to as "crunch time" in clinical research. Decisions made earlier in the trial are tested here, and timelines are often measured in days rather than months. Strong Clinical Data Management (CDM) practices during close-out are essential to protect patient safety, maintain data integrity, and support confident downstream decision-making.
Why Learn with TriTiCon
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.
In the close-out phase, practical understanding is critical. Locking a database, declaring a clean file, delivering data, and archiving documentation are not theoretical exercises—they are tightly regulated, highly scrutinized activities with little tolerance for error.
TriTiCon's approach focuses on how close-out actually works in practice: clean file meetings, classification of protocol deviations, database lock mechanics, interim and partial locks, data delivery packages, and the realities of archiving and system decommissioning.
1
Clinical Data Processing Completion and Clean File
- Completing data collection, cleaning, and consolidation activities
- Understanding what a clean file means and why it is a critical milestone
- The purpose and structure of the Clean File Meeting
- Classification of protocol deviations and their impact on analysis populations
- Documentation required to declare a dataset ready for analysis
2
Database Lock, Trial Unblinding, and Data Delivery
- What database lock is and how it protects data integrity
- Understanding trial unblinding and when it applies
- Interim locks and partial locks for stepwise analysis
- Delivering final data and documentation for statistical analysis
- Key data formats, specifications, and supporting documents
3
Decommissioning, Archiving, and Close-Out Timelines
- Preparing systems and data for decommissioning
- Ensuring sites receive archivable versions of patient data
- Managing follow-up of serious adverse events after system shutdown
- Understanding the Trial Master File (TMF) and the DIA TMF Reference Index
- Archiving data and documentation in a compliant, structured way
- Typical close-out timelines and how proactive work can shorten them
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, biometrics, or data-focused roles. It is suitable for beginners to intermediate learners in clinical research.
Do I need prior clinical trial experience?
Basic understanding of clinical trials and CDM fundamentals is recommended. Prior modules on CDM set-up and conduct are helpful 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 credential.
How is this different from other CDM courses?
TriTiCon emphasizes industry-aligned workflows, documentation expectations, and timeline drivers based on real clinical trial experience. This helps learners build job-relevant understanding that can be applied across different organizations, trial types, and therapeutic areas.
Can this course help me transition into clinical data management?
Answer to the question goes here.
Description
The Clinical Data Management Close-out Process (TTC KW A05)
The Clinical Data Management Close-Out Process course is designed for professionals who want to understand how clinical data management activities are completed at the end of a clinical trial. It is suitable for beginners to intermediate learners in clinical research, including Clinical Trial Assistants, Clinical Research Associates (CRAs), aspiring Clinical Data Managers, and professionals working in clinical operations, biometrics, or data-focused roles.
In this course, you will learn how clinical data is finalized, verified, locked, delivered, archived, and formally closed out. The focus is on the critical final steps that ensure data is complete, reliable, traceable, and ready for analysis, regulatory review, and long-term retention.
The close-out phase is often referred to as "crunch time" in clinical research. Decisions made earlier in the trial are tested here, and timelines are often measured in days rather than months. Strong Clinical Data Management (CDM) practices during close-out are essential to protect patient safety, maintain data integrity, and support confident downstream decision-making.
Why Learn with TriTiCon
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.
In the close-out phase, practical understanding is critical. Locking a database, declaring a clean file, delivering data, and archiving documentation are not theoretical exercises—they are tightly regulated, highly scrutinized activities with little tolerance for error.
TriTiCon's approach focuses on how close-out actually works in practice: clean file meetings, classification of protocol deviations, database lock mechanics, interim and partial locks, data delivery packages, and the realities of archiving and system decommissioning.
What You'll Learn
Curriculum
1
Clinical Data Processing Completion and Clean File
- Completing data collection, cleaning, and consolidation activities
- Understanding what a clean file means and why it is a critical milestone
- The purpose and structure of the Clean File Meeting
- Classification of protocol deviations and their impact on analysis populations
- Documentation required to declare a dataset ready for analysis
2
Database Lock, Trial Unblinding, and Data Delivery
- What database lock is and how it protects data integrity
- Understanding trial unblinding and when it applies
- Interim locks and partial locks for stepwise analysis
- Delivering final data and documentation for statistical analysis
- Key data formats, specifications, and supporting documents
3
Decommissioning, Archiving, and Close-Out Timelines
- Preparing systems and data for decommissioning
- Ensuring sites receive archivable versions of patient data
- Managing follow-up of serious adverse events after system shutdown
- Understanding the Trial Master File (TMF) and the DIA TMF Reference Index
- Archiving data and documentation in a compliant, structured way
- Typical close-out timelines and how proactive work can shorten them
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, biometrics, or data-focused roles. It is suitable for beginners to intermediate learners in clinical research.
Do I need prior clinical trial experience?
Basic understanding of clinical trials and CDM fundamentals is recommended. Prior modules on CDM set-up and conduct are helpful 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 credential.
How is this different from other CDM courses?
TriTiCon emphasizes industry-aligned workflows, documentation expectations, and timeline drivers based on real clinical trial experience. This helps learners build job-relevant understanding that can be applied across different organizations, trial types, and therapeutic areas.
Can this course help me transition into clinical data management?
Answer to the question goes here.