Updates on CDISC Activities

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Presentation transcript:

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

Outlines Standards Updates Updates from FDA Upcoming events 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

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

New domains in SDTM IG 3.2 Interventions Events Findings Trial Design 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

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

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.

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

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

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

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. …”

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

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

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

Other Instem is sharing their sample SEND data Contact Jennifer Feldmann submit@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