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
- ADaM OCCDS v1.1 - Instructions for Reviewers
- ADaM OCCDS Conformance Rules - Instructions for Reviewers
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
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.