Data Management for Non-Data Managers
Online Course Course

Data Management for Non-Data Managers

  • Dates 16 May 2024
  • Location Zoom
  • Hours 5 hours
  • Language English
  • Hours 15:00-20:00 Brussels
  • 14:00-19:00 UK
  • 09:00am-02:00pm New York
$700 Until 22 Apr 2023
$780 Until 09 May 2024
$900 Until 16 May 2024
About the Course
Johann Daniel Weyer
Lecturer: Johann Daniel Weyer
Johann Daniel Weyer is the owner and Managing Director of ICRC-Weyer GmbH, an expert German consultancy and all-phase CRO. A life-long professional and learner within the CRO and scientific consulting fields for biopharma and medtech with wide and in-depth knowledge and experience across service areas, product types, and indications built over the course of a 30-year journey from the shop floor to company leadership. Since more than 15 years, he is sharing that experience as a trainer in academic and industry settings, with a focus on clinical, medical, and safety data management, medical coding, and the integration of multi-functional teams.

Data Management (DM) stands at a critical juncture in clinical studies. As such, understanding the role of DM, the differences in perspective between DM and other functions (clinical, operations, project management, medical, regulatory, safety), and how these differences may shape interactions, will add to improving the communication and collaboration in multi-functional teams, often involving people from different organisations.


This course will lead you step by step through the Data Management workflow in a clinical study, from the preparatory stages of system selection and Data Management Plan writing, over the role of Data Managers during the clinical conduct such as database maintenance, running of validation checks, and management of queries, to the final steps necessary for locking the database and transferring it to statisticians for performing the analysis.


  • Overview of Data Management in clinical studies
  • Regulatory Considerations
    • DM in the context of GCP, other topics and guidelines
  • Data Management Planning and Setup
    • essential DM documents, technology/system selection
  • Data Capture
    • EDC systems, ePRO, devices, external data
  • (Digression: DM legacy systems and processes)
  • Data Validation
    • automated checks and manual reviews, front end versus back end checks, types of discrepancies, query management
  • Data Coding
    • dictionary selection, brief discussion of different dictionaries (especially MedDRA)
  • (Digression: DM in decentralized and virtual trials)
  • Data Reconciliation
    • differences to Data Validation, reconciliation against vigilance data, reconciliation against other external data sources
  • Data Review
    • Data Managers in the preparation of and as contributors to (blinded) data review meetings
  • Database Lock
    • soft locks and hard locks, unlocking
  • Archiving & Documentation


At each point, we will be looking not only at the What and How of Data Management, but also at the Why, at What Can Be Done (and at what cost) and at What Cannot Be Done, and we will highlight points of contact between Data Managers and other roles as well as the different expectations that might lead to misunderstandings and other friction.

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