ADaM Structure for Occurrence Data Implementation Guide v1.1

Published Date:

Version 1.1 of the ADaM Structure for Occurrence Data (OCCDS) Implementation Guide presents statistical analysis data structure that describes the general data structure and content typically found in occurrence analysis. Examples of data that fit into this structure include those used for typical analysis of adverse events, concomitant medications, and medical history.

ADaM OCCDS v1.1 updates and harmonizes the content from ADaM OCCDS v1.0 and ADaM Structure for Adverse Event Analyses v1.0 and adds four new variables to allow multiple treatment emergent or on treatment flags to handle multiple periods or other analysis needs.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.