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.
CDASH Model v1.0 Japanese Translation
Comments due: 9 March 2019
The Japanese Translation Team in coordination with the Japan CDISC Coordinating Committee is pleased to announce CDASH Model v1.0 has been translated into Japanese; this translation is available for Public Review.
Blue Ribbon Commission Insights
Comments due: 4 April 2019
The Blue Ribbon Commission has been created to shape and guide CDISC’s future. Composed of global leaders from academia, the pharmaceutical industry, government agencies (including regulatory bodies), patient foundations and fellow standards development organizations, the Blue Ribbon Commission has agreed on the following insights to advise the CDISC Board and leadership in serving clinical data standards needs now and in the coming decade.
CDISC is inviting our stakeholders to comment on these insights during a 60-day Public Review period. Make your voice heard; your feedback is essential in shaping CDISC Standards to impact the future of clinical research.
SENDIG-Animal Rule v1.0
Comments due: 29 April 2019
The SENDIG-Animal Rule v1.0 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.
Study Data Tabulation Model (SDTM) v1.8
Comments due: 29 April 2019
SDTM v1.8 serves as the model for the SENDIG-Animal Rule v1.0 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.
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