Transcript 20140320 DC CDISC UG - Sergiy Sirichenko

Updates on CDISC Activities
Sergiy Sirichenko
DC CDISC User Group Meeting,
DC, 2014-03-20
Outlines
 Standards Updates
 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
2
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
3
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
4
UG for Multiple Sclerosis V1.0
 February, 2014
 http://www.cdisc.org/therapeutic
 Draft version 1.0 based on SDTM v1.4
 Comments Due April, 1st
 Examples use the following SDTM domains
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
 Examples cover
Medical History and Disease Course
Relapse
Visual Acuity and Contrast Sensitivity
Optical Coherence Tomography Imaging
Visual Evoked Potential
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*

7
Note: * Domain is new in SDTMIG v3.2; ** Domain was not published in SDTMIG v3.1.3 and is not final.
8
http://www.cdisc.org/stuff/contentmgr/files/0/2356ae38ac190ab8ca4ae0b222392b37/misc/cfast_ta_program_overview_february_2014.pdf
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
9
Dataset-XML Specification V1.o
 November, 2013
 http://portal.cdisc.org/CT/Review%20Documents/Forms/AllItems.asp




x
Dataset-XML
Was developed as an alternative to SAS Xport
Require define.xml to read data
FDA is running an evaluation pilot
10
All “CDISC Standards Latest Updates”
 http://www.cdisc.org/
11
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
12
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
13
adjudications in the Data Guide”
CDER/CBER Position on Use of SI Units for
Lab Tests
 October, 2013
 http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm372
553.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-ofPhase 2 meeting.
…”
14
FDA is now accepting Define.xml v2.0
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/def
ault.htm
15
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
http://cdiscportal.digitalinfuzion.com/CDISC%20User%20Networks/default.aspx
16
PharmaSUG
 June 1st-4th, San Diego, CA
 http://www.pharmasug.org/us/index.html
 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)
17
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 March will support
 SDTM IG3.2
 Define.xml v2.0
 Dataset-XML
18