CDISC invites you to submit comments on version 1.0 of the ADaM Implementation Guide for Medical Devices and the associated conformance rules during Public Review. The data structures presented in the guide are intended to address the typical statistical analysis needs of data from clinical trials in which medical devices are used and included in analysis.
To Provide Comments:
View the draft: ADaM Implementation Guide for Medical Devices
- Instructions for providing comments: ADaMIG-MD - Instructions for Reviewers
View the rules: ADaMIG-MD Conformance Rules
- Instructions for providing comments: ADaMIG-MD 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. 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.
Thank you for contributing your time and expertise.