Summary
At this two-day course you get the rare opportunity to learn the basics of successful clinical data management and – importantly – the stakeholders involved in clinical trials.
You will participate in a mix of lectures and workshops in which you, among other things, work on data management documents.
At the course you get answers to questions such as
- What is clinical data management?
- What is the regulatory landscape?
- What about data integrity?
- What are responsibilities of a data manager?
- What is the clinical data management workflow, key documents, and deliveries?
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Keywords
- Data management
- Data integrity
- Roles and responsibilities
- Stakeholder management
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Is this course for you?
This course is for anyone new to data management in clinical trials in a pharma company, biotech or CRO. It’s also for you if you wish to step into data management from a background of e.g. (project) nurse or programmer.
What you will learn
- The fundamental elements of clinical data management
- How to navigate the clinical data management workflow
- Key documents, data handling and deliveries
- Stakeholder management in clinical trials
- Hands-on learnings on data management documents
What your company will get
- An employee who is quickly up-to-speed on the practical aspects of clinical data management.
- An employee who understands the relationship between the many elements of clinical data management, e.g. data workflow, stakeholder management, key documents and deliveries.
Course calendar
Day 1
- Clinical development and study design
- Regulatory landscape
- Data Integrity
- Data management workflow
- Startup phase: turning the protocol into the DM area
- Startup phase continuing: Data flow and validation
Day 2
Conduct phase cont. – Data handling and cleaning
Closure phase, archiving and TMF deliverables
Post database lock phase
The Data Management role from a perspective
How to become a Data Manager
Registration
Registration deadline3 Jun 2024
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to optional readings via your personal Atrium log-in.
This material is important if you have little or no background in a pharma company or with GCP.
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
Send me a message