Transcript Agenda - Organisation

German CDISC
User Group
Kopenhagen, 22 April 2008
Agenda
Time
Topic
17:00-17:15 Welcome
Who
DR, JH
17:15-17:30 German CDISC User group characteristics
DR
From SDTM to ADaM and beyond: Practical
17:30-18:15
experience and key learnings
JH
18:15-18:45 Group discussion
All
18:45-19:00 German CDISC User group organization
19:00-20:00 Joint reception with other User Groups
DR, all
All
2
Participants
Name
Company
Name
Company
Monika Kawohl
Accovion GmbH
Markus Stoll
IBM Global Business Services
Dagmar Kottig-Roth
Accovion GmbH
Elke Sennewald
Kendle
Arnold Edelbert
Accovion GmbH
Sabine Kiederle
Kendle
Pia Ebhart
BAXTER BioScience
Sabine Laukamp
Kendle
Nicole Baumgartner
BAXTER BioScience
Johannes Hüsing
KKS Heidelberg
Ingeborg Cil
Baxter Innovations GmbH
Sebastian Claudius Semler
TMF e.V.
Susanne Pangritz
Bayer Healthcare
Johannes Drepper
TMF e.V.
Gisela Potts
F. Hoffmann-La Roche Ltd.
Joel Hoffman
Waban Software
Daniel Rehn
F. Hoffmann-La Roche Ltd.
Olga Steinle
XClinical GmbH
Kurt Hellstern
Hands-on GmbH
Claus Lindenau
XClinical GmbH
3
German CDISC User Group
Characteristics
4
Participation in CDISC Teams
9
8
7
6
5
4
3
SDTM
LAB
Terminology
CDASH
ODM
2
1
0
5
CDISC Models Experts
14
12
SDTM
10
ADaM
8
LAB
6
ODM
4
Terminology
2
0
6
Areas of interest
SDTM
ODM
Define-XM L
ADaM
LAB
FDA
Terminology
CT
Data Archiving
CDISC Compliant Software
CRF standards
CDASH
IT infrastructure & tools
7
Presentations from Team Members at the
CDISC European Interchange
8
CDISC News
9
FDA’s Draft PDUFA IV 5-Year IT Plan
10
10
FDA’s Draft PDUFA IV 5-Year IT Plan
•
The foundation for the standardized clinical content is the Clinical Data
Interchange Standards Consortium (CDISC) Study Data Tabulation
Model (SDTM). The SDTM will also include nonclinical requirements
based on the Standard for Exchange of Nonclinical Data (SEND)
models that is being harmonized with the SDTM. The CDISC content
will be sent to FDA as an XML message using the Health Level Seven
(HL7) Reference Information Model (RIM) and harmonized with the
Biomedical Research Integrated Domain Group (BRIDG) Model.
•
SDTM version 3.1.1 submissions are accepted by FDA. A draft
implementation guide for SDTM 3.1.2 is currently under review by
CDISC and FDA. FDA and CDISC are in the process of forming a
communications team that will ensure SDTM meets FDA’s scientific
requirements.
11
Source: Draft PDUFA IV Plan, December 2007, Page 23
eSubmission of Clinical Content Today
SDTM
SAS V5
XPT
12
eSubmission of Clinical Conent Tomorrow
Metadata
SDTM
+
Derived
(ADaM)
+ +
SAP
?
HL7 V3 Message(s)
13
A Possible Timeline
2008
2009 2010
Review + Two
Years
New Rule
Available
2011
Mandatory
electronic
Submission
2012
2013
2014
2015
2016
2017
Two Years ??
CDISC HL7
Messages
Available
Withdrawl
of SAS XPT
files
SDTM CONTENT
SAS XPT Mechanism
CDISC HL7 Development
CDISC HL7 Production Message(s)
Warning
The dates presented on this slide are based upon the author’s knowledge
as of January 31st 2008. They are not official CDISC or FDA policy!
14
14
CDISC Case Study
15
CDISC Case Study
Protocol
Form
Setup &
Config
Data
Capture
Mapping
First German
CDISC User
Group Meeting
Protocol
Analysis
Submission
Review
Today
CDASH
SDTM & ADaM
ODM
LAB
XML
16
CDISC Case Study
From SDTM to ADaM and beyond: Practical experience
and key learnings
Joel Hoffman, Waban Software
17
Group Discussion
18
Group Discussion
More information:
• European CDISC Interchange:
• CDISC Website (Members only area):
– Pilot project report
– Pilot Project Submission Package
– Metadata Tools used in the Pilot Project
19
German CDISC User Group
Organization
20
User Group Objectives
•
Support CDISC
–
–
–
–
–
–
•
Test models
Propose implementation approaches
Propose new domains
Provide a network to address domain specific issues
Promote/distribute standards
Support CDISC activities
Support User Community
–
–
–
–
–
–
Provide more direct links to CDISC Organization
Contact Network
Discussion Forum
Expansion of community (i.e., other Networks)
More involvement
Support for implementation
•
•
Documentation of issues/resolutions
Access to documentation (regardless of
implementation level at individual company)
21
Current German CDISC User Group Portal
http://groups.yahoo.com/group/german_cdisc_ug/
22
Future German CDISC User Group Portal
http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/
23
Contact Network
• German CDISC User Group Portal
–
–
–
–
–
News / Announcements
Shared documents
Discussions
Surveys
Member lists with profiles
• German CDISC User Group Meetings
– Working Groups
– Case Studies and Best Practices
– CDISC News
24
General Introduction into CDISC Models
Course:
•
•
•
•
CDISC Interchange
CDISC Workshops
CDISC training courses
CDISC vLearning
Prerequisites:
SDTM Theory & Application
A basic understanding of relational database
design is helpful but not required.
Brief
Description:
The SDTM (Study Data Tabulation Model) is a
specification in the FDA eCTD (electronic
Common Technical Document) Guidance as the
model for submitting clinical and preclinical data
to the FDA in support of marketing applications.
This class consists of 1) a detailed review of
SDTM concepts, SDTM domain models, and
relationship tables, 2) a discussion of common
implementation issues, and 3) exercises including
CRF-annotations and creation of datasets that
reinforce attendees' understanding of the SDTM
and the SDTM Implementation Guide.
Attendees
Will Learn:
1) The theory behind SDTM and the format of
data that will be required for submission to the
FDA.
2) Key SDTM concepts.
3) How to represent various types of collected
data in the SDTM format.
Audience:
Standards Managers, Data Managers,
Statisticians, Programmers, and others involved
in the creation or submission of data. This course
is also intended for those within regulatory
agencies who will use or process data in this
format.
25
Q&A
26
Closing remarks
27
Next Meeting
• Early September 2008
• Basel
•
•
•
•
•
CDISC News
CDISC Case Study
Group Discussion
User Group Steering Team
Working Groups
28
Herzlichen Dank!
Bis zum nächsten Mal und…
weitere Teilnehmer sind immer willkommen!
•
Kontakte:
–
–
Daniel Rehn ([email protected])
Ann-Sofie Bergstrom ([email protected])
29