FIRST QUARTER 2016 CDISC STANDARDS UPDATES


Updates about our Foundational Standards, Therapeutic Area Standards, Healthcare Link and SHARE can be found in this section.


Therapeutic Area Standards Update Alana St. Clair, CDISC Manager, Standards Development


Between 1997 and 2008, CDISC developed standards to support the exchange and analysis of data common across research studies (i.e. safety information). Our stakeholders began requesting standards to support the data specific to therapeutic areas (i.e. efficacy data). Since 2008, CDISC has worked to develop more than 25 TA standards, most of which have been developed through the CFAST initiative. These CDISC standards allow data from multiple trials to be more easily grouped for reporting and analysis. Below is an update on this effort for Q1 2016:


Two new TA Standards were published in in the first quarter: Chronic


Obstructive Pulmonary Disease


(COPD) v1.0 and Tuberculosis v2.0; three more are expected to be published in Q2 2016: Breast Cancer v1.0, Diabetic Kidney Disease v1.0 and Rheumatoid Arthritis v1.0.


There are three draft TA standards nearing Public Review: Diabetic Kidney Disease v1.0, Rheumatoid Arthritis v1.0 and CV Imaging v1.0.


For information on how to provide comments please contact astclair@cdisc.org.


Additional information


about TA standards can be found on the CDISC website.


For more information on CFAST projects starting in 2016, see the CFAST pipeline posted here. If you are interested in participating on one of the upcoming TA projects, please contact: volunteer@cdisc.org.


For more information on CFAST, please visit the CDISC website.


Foundational Standards Update Barrie Nelson, CDISC VP, Standards, Technology & Technical Services


The ADaM Implementation Guide v1.1 was published on 16 February and the ADaM Structure


Occurrence Data is now a final published version, moving from its provisional status with the release of the new ADaMIG.


The SDTM conformance rules are currently in public review, and the FDA is


also reviewing the


documentation and preparing feedback. The next step will be to address comments and prepare a final version for publication.


The Clinical Trial Registry CTR-XML is being readied for final publication. Feedback from initial use of CTR-XML will be valuable input to the CTR2 project that will expand CTR-XML to integrate results summaries. For more information on CTR2 please see the featured


article by Paul Houston, Head of


Operations for the CDISC Europe Foundation, in the 2015 Fourth Quarter Newsletter.


The CDASH Model v1.0 and CDASHIG v2.0 are going through the final stages of preparation for public review. The CDASH model and CDASHIG will provide standardization, consistent implementation and best practices and will harmonize with SDTM to provide conformance and traceability.


The SDTMIG v3.3 Batch 3 materials are undergoing internal CDISC review and will be out for public review once all comments have been addressed. The Batch 3 package will contain a number of proposals along with new or updated domain specifications.


Please visit the links below to view more updates on the CDISC standards:


Key Accomplishments in 2015 2016 CDISC Roadmap CFAST Program Overview CDISC Foundational Standards CDISC Therapeutic Area Standards CDISC Healthcare Link


CDISC CDIS CDI C WEBSIT LINK WEBSITE LINK 13 liin lliin liin lliin for


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