Current Public Reviews

Current Public Reviews

CDISC invites interested stakeholders to submit comments on the following standards available for public review. We rely 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.

Controlled Terminology Package 40  Comments due: 18 Oct 2019

The public review package consists of 17 documents: 

  • ADaM
  • Define-XML
  • Device
  • General*
  • CDISC Glossary*
  • Laboratory Terms*
  • Microbiology*
  • Oncology
  • PK
  • Protocol Entities
  • QRS
  • SDTM Domain
  • SEND*
  • Units of Measure
  • P40 Requests Denied
  • Rules for MB and MS

An * indicates that changes or retirements of existing CDISC Submission Values are included on the “Changes to Existing” tab in the document. Please review these changes as there may be submission value changes or term deprecations.

The public review files and comments will be using the CDSIC Wiki.  Please access the link below and follow the instructions:

Therapeutic Area User Guide for Type 1 Diabetes - Pediatrics and Devices  Comments due: 11 Nov 2019

In the U.S. alone, over 1.5 million people live with Type 1 Diabetes (T1D); approximately 30,000 people are diagnosed every year.  

With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC is developing new T1D CDISC standards that will extend published diabetes standards by developing machine-readable metadata in the following focus areas: Pediatrics, Devices, Prevention, and Exercise. These standards will make it easier for all stakeholders (clinicians, researchers, drug development companies, and regulatory authorities) to  share and compare data to foster innovation and to evaluate the effectiveness of emerging T1D treatments.

We invite you to provide comments on TAUG-T1D during the open Public Review period. Public review is a key quality step in our Standards Development Process.

View the draft: TAUG-T1D.