Road map of clinical data management

Learn the basics of clinical data management and stakeholder management.

12. Sep 2022

3 days course

English

18,450 DKK ex VAT
(app. 2,481 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

At this three-day course you get the rare opportunity to learn the basics of successful clinical data management and – importantly – the stakeholders involved in clinical trials.

Day 1 and 2 provide you with knowledge which is put into practice on Day 3 in hands-on 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?

    Key words

    • Data management
    • Data integrity
    • Roles and responsibilities
    • Stakeholder management
    Read more

    Course leader(s) & Lecturer(s)

    • Katja Bernstein
      Course leader
      Senior Manager
      H. Lundbeck A/S
    • Britt Bech Andersen
      Course leader
      Owner
      BBA Data Consult
    See all

    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 12. Sep 2022
    12. Sep 2022 8:30-16:00

    Day 1

    • Clinical development and study design
    • Regulatory landscape
    • Data Integrity
    • The Data Management role
    • Data management workflow

    13. Sep 2022 8:30-16:00

    Day 2

    • Startup phase: turning the protocol into the DM area
    • Startup phase continuing: Data flow and validation
    • Conduct phase – CDM deliveries in a study team
    • Conduct phase cont. – Data handling and cleaning
    • Closure phase, archiving and TMF deliverables
    14. Sep 2022 8:30-16:00

    Day 3

    • Workshops og discussions
    Practical information

    Registration

    Registration deadline
    12. Sep 2022
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    12 - 14 Sep
    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.

    Course leader(s)

    Katja Bernstein
    Senior Manager
    H. Lundbeck A/S
    Britt Bech Andersen
    Owner
    BBA Data Consult

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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