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Updates on CDISC Activities

Updates on CDISC Activities. Sergiy Sirichenko. NJ CDISC User Group Meeting, NJ, 2014-01-14. Outlines. Standards Updates SDTM 1.4/IG3.2 Therapeutics: Alzheimer, MCI and Asthma StudyDataSet -XML CDASH SAE Updates from FDA Define.xml v2 SI units Upcoming events CDISC INTRAchange

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Updates on CDISC Activities

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  1. Updates on CDISC Activities Sergiy Sirichenko NJ CDISC User Group Meeting, NJ, 2014-01-14

  2. Outlines • Standards Updates • SDTM 1.4/IG3.2 • Therapeutics: Alzheimer, MCI and Asthma • StudyDataSet-XML • CDASH SAE • Updates from FDA • Define.xml v2 • SI units • Upcoming events • CDISC INTRAchange • Other

  3. New SDTM version • December, 2013 • http://www.cdisc.org/sdtm • SDTM v1.4 • Version of new SDTM IG is 3.2, rather than 3.1.4 • New design of SDTM IG document as PDF portfolio  • New IG-AP describes how to handle data about • Devices • “Associated persons” who are not study subjects • New variables were added into SDTM model • New special purpose domains • 11 new domains in IG

  4. New domains in SDTM IG 3.2 • Interventions • EX – Exposure as Collected • PR – Procedures • Events • HO – Healthcare Encounters • Findings • DD – Death Details • IS - Immunogenicity Specimen Assessment • MI – Microscopic Findings • MO – Morphology • RP – Reproductive System Findings • SS – Subject Status • SR – Skin Response • Trial Design • TD – Trial Disease Assessment

  5. UG for Alzheimer’s Disease and Mild Cognitive Impairment V2.0 • December, 2013 • http://www.cdisc.org/therapeutic • Provisional version Based on SDTM v1.4 • Examples are added for CSF biomarker and imaging biomarkers endpoints • QS Terminology • Ten additional clinical scales relevant to AD and MCI • Examples are adjusted with new SDTM/SDTM IG versions; • Family History examples moved from MH to APMH (Associated Persons Medical History) domain • ApoE genetics data examples are moved from SC to PF (Pharmacogenomics Findings) domain

  6. Therapeutic Area Data Standards User Guide for Asthma v1.0 • November, 2013 • http://www.cdisc.org/therapeutic • Provisional version Based on SDTM v1.4 • Examples use the following SDTM domains • AG – Procedure Agents** • CM – Concomitant Medications • AE – Adverse Events • HO – Healthcare Encounters* • MH – Medical History • LB – Laboratory Test Results • RE – Respiratory System Findings** • FA – Findings About • SR – Skin Response* • DI – Device Identifier* • DU – Device-in-Use* • Note: * Domain is new in SDTMIG v3.2; **Domain was not published in SDTMIG v3.1.3 and is not final.

  7. CDASH Serious Adverse Event Supplement Version 1 November, 2013 http://www.cdisc.org/cdash Final version Extends AE domain to include data elements needed for SAE info Will allow the sponsor to generate E2B message for reporting ICSR Allows to skip data re-entry

  8. StudyDataSet-XML Specification V1.o • November, 2013 • http://portal.cdisc.org/CT/Review%20Documents/Forms/AllItems.aspx • SDS-XML • been released for public comment • due date is January 13th, 2014 • was developed as an alternative to SAS Xport v5 format

  9. All “CDISC Standards Latest Updates” http://www.cdisc.org/

  10. CDER/CBER Position on Use of SI Units for Lab Tests October, 2013 http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm372553.htm “CDER and CBER are evaluating an approach to transition to general acceptance of laboratory data in clinical trials that are measured and reported in Système International (SI) units instead of U.S. Conventional units. The objective is to establish an agency-wide policy on the acceptance of SI units in product submissions. … While this evaluation is underway, sponsors are strongly encouraged to solicit input from review divisions as early in the development cycle as possible to minimize the potential for conversion needs during NDA/BLA review. CDER and CBER encourage sponsors to discuss this issue with FDA before the start of Phase 3 trials.  In some cases the issue may warrant discussion with FDA at the End-of-Phase 2 meeting. …”

  11. FDA is now accepting Define.xml v2.0 http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm

  12. CDISC INTRAchange 2014 February, 25th-27th, Silver Spring, MD 2 times a year Internal CDISC working group meeting Face-to-face meetings for all CDISC development teams https://www.cvent.com/events/all-team-intrachange-2014/registration-2254424c1f2f408c9c3e19681a5deff9.aspx

  13. PharmaSUG June 1st-4th, San Diego, CA http://www.pharmasug.org/us/index.html The Pharmaceutical Industry SAS® Users Group Annual Conference Call for Papers is extended to January, 19th

  14. Other • Instem is sharing their sample SEND data • Contact Jennifer Feldmannsubmit@instem.com for details. Inlcude "Send me SEND" in the subject  • New OpenCDISC release in February will support SDTM IG3.2 and Define.xml v2.0

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