Controlled Terminology Package 45

CDISC invites you to submit comments during the Public Review for Controlled Terminology Package 45, which consists of the following 14 documents:

  • Terminology Development Rules for all Codelists
  • Terminology Development Rules for Lab and Unit
  • Define-XML*
  • General
  • Laboratory*
  • Microbiology/Immunology
  • Oncology
  • PK
  • Protocol Entities*
  • SDTM Domain
  • SEND*
  • SPECTYPE_SPECCOND
  • Units of Measure
  • P45 Requests Denied

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.

Public Review Files and Instructions for Reviewers are available on the CDISC Wiki.

Public review is a key quality step in our Standards Development Process.  CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research.

Thank you for contributing your time and expertise.