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CDISC/CDASH

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Work Packages
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CDISC/CDASH

An overview of some of the CDISC standards, the SDTM and CDASH standards in particular and an exploration of how these standards could serve ADMIT and its target public . Standards will improve and streamline the data collection and management processes and facilitate programs and data sharing.

Workpackage

Introduction to CDISC
Introduction to SDTM
Introduction to CDASH
How CDISC fits ADMIT and its target public

Recommendations from the group

Practical knowledge is lacking.
Therefore there is a need of clear procedure(s), how to use the CDASH and SDTM concept and documentation. The input of the CDASH user community will be an important aspect to consider in the development process.

Outputs

Presentation of the 4th ADMIT workshop (see in attachment)

Future work

  • Further communication with CDISC
  • Exploring the CDISC course‘End-to-End’, which has academic institutions, involved in medical research and healthcare as a target audience.
  • Clear procedure for data collection & submission
  • CRF annotated with CDASH/SDTM variables + metadata files
  • Survey of data standards

WP Leads

Name : Mary Thiongo 1, Brian Mutinda 2, Harry van Loen 3
Affiliation : 1International Centre for Reproductive Health, Mombasa, Kenya, 2DNDi Africa regional office , 3 Institute of Tropical Medicine
Contact : Mary.Thiongo [@] icrhk.org, bmutinda [@] dndi.org, hvanloen [@] itg.be

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Supported by

Institute of Tropical Medicine

Antwerp, Belgium

(This initiative) has been supported by Clinical Research Network project (Project 1.28)
of the DGD-ITM Framework Agreement sponsored by the Belgian Directorate-General for Development.

© 2023 Institute of Tropical Medicine