CDISC invites you to submit comments on the following during Public Review:
- SENDIG v3.1.1 - This is a second public review, limited to the removal of Assumption #2 from the PP Domain in SENDIG v3.1.
- SEND Conformance Rules v2.0 - Includes updates to Conformance Rules for SENDIG v3.0 as well as new conformance rules for SENDIG v3.1 and SENDIG v3.1.1.
SEND Conformance Rules v2.0 is intended to provide the most up-to-date rules for evaluating the conformance of SEND v3.0 and v3.1 datasets. The Conformance Rules, when used along with the SEND Implementation Guides, are intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities.
When released, Conformance Rules v2.0 will represent a cumulative package of current and previously published Conformance Rules for SENDIG versions thru 3.1. Another version of Conformance Rules will be released to include SENDIG v3.1.1 at a later date.
Instructions for Reviewers
To provide comments:
- View the draft: SENDIG Conformance Rules v2.0
- Instructions for providing comments: 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.