Successful clinical data management

Learn the basics of clinical data management and stakeholder management.

10 - 11 Jun 2024

On location

English

12,600 DKK ex VAT

(app. 1,694 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

    1. The fundamental elements of clinical data management
    2. How to navigate the clinical data management workflow
    3. Key documents, data handling and deliveries
    4. Stakeholder management in clinical trials
    5. Hands-on learnings on data management documents

    What your company will get


    1. An employee who is quickly up-to-speed on the practical aspects of clinical data management.
    2. 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

    Starting 10 Jun 2024
    10 Jun 2024 9:00-16:00

    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

    11 Jun 2024 9:00-16:00

    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

    Practical information

    Registration

    Registration deadline
    3 Jun 2024
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    10 - 11 Jun
    Sometimes things change. This is the expected programme.

    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.

    You may also be interested in these courses

    Want to know more or need help?

    Contact Client Manager Christina Spangsberg at +45 39 15 09 22

    Send me a message