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

2. Outlines Standards Updates Updates from FDA Upcoming events Other
SDTM 1.4/IG3.2
Therapeutics: Multiple Sclerosis, Alzheimer, MCI and Asthma
Dataset-XML
CDASH SAE
Updates from FDA
New FDA Guidances on Standard Data for Electronic Submissions
Define.xml v2
SI units
Upcoming events
CDISC Interchanges and User Groups
PharmaSUG
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
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

5. UG for Multiple Sclerosis V1.0
February, 2014
Draft version 1.0 based on SDTM v1.4
Comments Due April, 1st
Examples use the following SDTM domains
Examples cover
CE – Procedure Agents
MH – Medical History
MO – Morphology
NV – Nervous System Findings *
OE – Ophthalmic Exams *
FA – Findings About
TS – Trial Summary
DI – Device Identifiers * *
DU – Device In-Use * *
Note: * Domain was not published in SDTMIG v3.1.3 and is not final; * SDTMIG for Medical Devices
Medical History and Disease Course
Relapse
Visual Acuity and Contrast Sensitivity
Optical Coherence Tomography Imaging
Visual Evoked Potential

6. 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

7. 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.

9. 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

10. Dataset-XML Specification V1.o
November, 2013
Dataset-XML
Was developed as an alternative to SAS Xport
Require define.xml to read data
FDA is running an evaluation pilot

11. All “CDISC Standards Latest Updates”

12. New FDA Guidances on Standard Data for Electronic Submissions
Study Data Technical Conformance Guide and Data Standards Catalog
Guidance on Electronic Submissions: Standardized Study Data
Guidance on Submissions in Electronic Format--Submissions under the Federal Food, Drug, and Cosmetic Act
February, 2014
Draft Guidance
90 days period for public comments

13. Study Data Technical Conformance Guide
New expected documents
Study Data Standardization Plan
Study Data Reviewer’s Guide
Additional requirements. E.g.,
“The Subject Elements domain should be included…”
“The AE domain should include all adverse events that were recorded in the
subjects’ case report forms, regardless of whether the sponsor determined that particular events were or were not treatment-emergent.”
New Sections. E.g., #8. Data Fitness
Study Data Validation Rules
Conformance (data standards)
Quality (support meaningful analysis)
Study Data Traceability
Legacy Data Conversion Plan and Report
aCRFs for legacy data elements
“Record significant data issues, clarifications, explanations of traceability, and adjudications in the Data Guide”

14. 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. …”

15. FDA is now accepting Define.xml v2.0

16. CDISC Meetings 2014 Interchange
Europe : April, 7th - 11th, Paris, France
USA: November, 10th – 14th, North Bethesda, MD
Use Groups
Boston: March, 28th, hosted by PAREXEL, Bilirica, MA
Oncology Area Standards
CDISC End-to-End
Atlantic: April, 17th, hosted by Celgene, Summit, NJ
6 presentations
Webex available
Details including agenda and registration info on

17. PharmaSUG June 1st-4th, San Diego, CA
The Pharmaceutical Industry SAS® Users Group Annual Conference
Online Registration is open
Lowest fees until April, 28th
Paper abstracts are published
Special “Data Standards” section (19 papers)

18. Other Instem is sharing their sample SEND data
Contact Jennifer Feldmann for details. Inlcude "Send me SEND" in the subject 
New OpenCDISC release in March will support
SDTM IG3.2
Define.xml v2.0
Dataset-XML