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This webinar will highlight the changes in version 1.2 of the ADaM Implementation Guide, which is scheduled to be published this year. Changes include important clarifications to existing text, standard nomenclature for stratification variables within ADSL, and a recommended approach for bi-directional toxicity grades. We will also discuss the removal of PARQUAL, which had been included in the document when it went out for Public Review.
Additionally, the webinar will discuss ADaM Integration, which supplements the published ADaM standards and presents general considerations for integration. New ADaM structures, allowing for complex integrations with multiple records per subject in an integrated ADSL, will be presented. A method for handling simple integrations will also be described.
Presenters:
-Brian Harris, Director of Biometrics Operations, MedImmune (AstraZeneca)
-Deborah Bauer, Assistant Director, Sanofi
Presenters
- Brian Harris, Director of Biometrics Operations, MedImmune (AstraZeneca)
- Deborah Bauer, Assistant Director, Sanofi