1. Updates on CDISC Activities
Sergiy Sirichenko
NJ CDISC User Group Meeting,
NJ,

2. 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

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 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

5. UG for Alzheimer’s Disease and Mild Cognitive Impairment V2.0
December, 2013
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
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
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
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”

10. CDER/CBER Position on Use of SI Units for Lab Tests
October, 2013
“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

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

13. PharmaSUG June 1st-4th, San Diego, CA
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 Feldmann for details. Inlcude "Send me SEND" in the subject 
New OpenCDISC release in February will support SDTM IG3.2 and Define.xml v2.0