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.
A draft of version 2.1 of the Clinical Data Acquisition Standards Harmonization (CDASH) is available for Public Review. CDASH v2.1 comprises the CDASH Model v1.1 and CDASH Implementation Guide v2.1. Significant changes include:
- Inclusion of remaining SDTMIG v3.2 domains not published in CDASHIG v2.0 (i.e., MB, MS, TU, TR, RS, AP--).
- Conversion of all CRF examples to metadata table-defined aCRFs.
- Resolution of issues submitted for enhancements and error corrections identified in CDASHIG v2.0 and CDASH Model v1.0.
- Changed CDASHIG and CDASH Model Variable Labels, where needed, to more closely align with SDTMIG and SDTM Variable Labels, respectively.
Comments due: 3 Jul 2019
CDISC Controlled Terminology Package 39 is available for public review. The public review package consists of 14 documents:
- Laboratory Terms*
- Protocol Entities*
- SDTM Domain*
- SEND Animal Rule
- Units of Measure*
- P39 Requests Denied
- Rules for MB and MS_2019-06-21
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..
Comments due: 19 Jul 2019
Version 1.0 of the SENDIG-Animal Rule is based on the SDTM v1.8 and is intended to be used in conjunction with the SENDIG v3.1 for data being submitted to the US Food & Drug Administration (FDA) under the Animal Rule. The regulations, commonly known as the Animal Rule (AR), provide a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.
Under the AR, efficacy is established based on adequate and well-controlled studies in animal models of the human disease or condition of interest, and safety is evaluated under the pre-existing requirements for drugs and biological products. Like other implementation guides based on the SDTM, the SENDIG-AR is intended to guide the organization, structure, and format of standard tabulation datasets.
Comments due: 13 Aug 2019