Transcript Pres5_Updates on CDISC activities - 20140113 NJ

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
 Other
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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
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New domains in SDTM IG 3.2
 Interventions
 EC – 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
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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
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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*

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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
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StudyDataSet-XML Specification V1.o
 November, 2013
 http://portal.cdisc.org/CT/Review%20Documents/Forms/AllItems.asp
x
 SDS-XML
 been released for public comment
 due date is January 13th, 2014
 was developed as an alternative to SAS Xport v5 format
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All “CDISC Standards Latest Updates”
 http://www.cdisc.org/
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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.
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…”
FDA is now accepting Define.xml v2.0
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/def
ault.htm
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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
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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
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PhUSE CSS Conference
 March 16th-18th, Silver Spring, MD
 http://www.phuse.eu/css
 Hand-on working group meetings
 CSS working group 2014 Activities
 Optimizing the Use of Data Standards
 Development of Standard Scripts for Analysis and Programming
 Emerging Technologies
 Non-Clinical Road-map and Impacts on Implementation
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Other
 Instem is sharing their sample SEND data
 Contact Jennifer Feldmann [email protected] 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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