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Embracing the SDTM Mindset from Study Start-up to Mitigate Compliance Issues

Join our live webinar to learn how applying study data tabulation model (SDTM) knowledge at the start of a study reduces compliance issues when preparing for analysis and regulatory submission.

Nowadays, it is impossible to imagine clinical research without the existence of the CDISC SDTM data standards, which enable us to create structured, aligned, transparent and comprehensive databases from raw data.

Creating such CDISC SDTM-compliant databases is crucial for statistical analysis and regulatory submissions. SDTM compliance is often considered to be quite challenging, especially with the evolution towards more complex study data, adaptive or innovative study designs and the shortening of study timelines.

This webinar will discuss the importance of applying SDTM knowledge at the start of a study and how decisions made upstream of SDTM-compliant database creation have a large impact on SDTM compliance and submission readiness.

During the webinar, the common mistakes/pitfalls at several stages of the study process that impact SDTM compliance will be illustrated. In addition, the importance of data management in the compliance issue mitigation process will also be explored.

Agenda

This webinar will cover:

  • Introduction
  • The road to SDTM compliance
  • Conclusion
  • Q&A

Presenter

This webinar is presented by Els Janssens, Executive Manager, Secure Data Office. Els Janssens has over nine years of experience in the field of clinical data management and CDISC SDTM data standards. In her current role, she is responsible for the overall management of a dedicated team within data management.

Can't make a live session?

Register now and receive a complimentary recording after the live event.

For further information, please contact:

Health Science
t: +32 15 27 32 45

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