ADaM OCCDS v1.1 and Conformance Rules

Comments Due By

CDISC invites you to submit comments on version 1.1 of the ADaM Structure for Occurrence Data (OCCDS) and the associated Conformance Rules during Public Review.

The most significant changes since the previous version include:

  • Addition of four new variables to allow multiple treatment emergent or on treatment flags to handle multiple periods or other analysis needs.
  • Addition of Conformance Rules for defining and creating ADaM OCCDS version 1.1 datasets. ADaM Conformance Rules may be used to validate datasets against a subset of these rules, which are objective and able to be evaluated unambiguously. Conformance Rules are defined to be machine-readable (i.e., programmable within computer software) and capable of being implemented by ADaM users

To Provide Comments

View the Drafts:

Instruction for Reviewers

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Public review is a key quality step in our Standards Development Process. Thank you for contributing your time and expertise. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.