Work Stream Templates Basel, September 2, 2008.

Slides:



Advertisements
Similar presentations
CLINTON W. BROWNLEY AMERICAN UNIVERSITY PH.D. CANDIDATE SEPTEMBER 2, 2009 BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards.
Advertisements

CDISC Open Source and low-cost Solutions
Education Work stream Update English Speaking User Network F2F Meeting 15 th of December 2008 Veronica Martin.
What’s New with CDISC Wayne R. Kubick CDISC CTO.
Emerging Technologies Project Prioritization Washington DC, March 18 th 2013.
What is workflow?  A workflow is a structured way of defining and automating structures and procedures within an organization. What is workflow management.
© 2008 Octagon Research Solutions, Inc. All Rights Reserved. 1 PhUSE 2010 Berlin * Accessing the metadata from the define.xml using XSLT transformations.
7. German CDISC User Group Meeting Define.xml Generator ODM Validator (define.xml validation) 2010/03/11 Dimitri Kutsenko Marianne Neumann.
Monika Kawohl Statistical Programming Accovion GmbH Tutorial: define.xml.
CDISC and how Stata can help us implement it
Beyond regulatory submission - Standards Metadata Management Kevin Lee CDISC NJ Meeting at 06/17/2015 We help our Clients deliver better outcomes, so.
PhUSE SDE, 28-May A SAS based Solution for define.xml Monika Kawohl Statistical Programming Accovion.
Improving Software Testability Adam Knight – Test Team Leader, Clearpace Ltd. April 29 th 2009.
CDISC Implementation Strategies: Lessons Learned & Future Directions MBC Biostats & Data Management Committee 12 March 2008 Kathleen Greene & A. Brooke.
Vertex and CDISC / MBC / 12March Vertex and CDISC Accomplishments and Strategy 12 March 2008 Lynn Anderson Associate Director Statistical Programming/Biometrics.
ODM-SDTM mapping Nicolas de Saint Jorre, XClinical June 20, 2008 French CDISC User Group Bagneux/Paris © CDISC & XClinical, 2008.
Antje Rossmanith, Roche 14th German CDISC User Group, 25-Sep-2012
CDISC XML Technologies Standards Development An Update Sam Hume
Second Annual Japan CDISC Group (JCG) Meeting 28 January 2004 Julie Evans Director, Technical Services.
Copyright © 2011, SAS Institute Inc. All rights reserved. Using the SAS ® Clinical Standards Toolkit 1.4 to work with the CDISC ODM model Lex Jansen SAS.
Basel, September 2, 2008 Work Stream Templates. 2 CDISC User Group Work Streams Goals Sharing of expertise and knowledge –Sharing of useful tools (e.g.
RCRIM Projects: Protocol Representation and CDISC Message(s) January 2007.
Dave Iberson-Hurst CDISC VP Technical Strategy
Overview of CDISC standards and use cases along the E2E data management process Dr. Philippe Verplancke ESUG Marlow, UK 27 May 2009.
Kopenhagen, 22 April 2008 German CDISC User Group.
© 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo 1 Clinovo 1208 E. Arques Avenue, Suite 114.
Brief Profile Proposal for 2012/13 presented to the Quality, Research & Public Health (QRPH) Planning Committee Landen Bain CDISC October 9, 2013.
Data Cleaning Using ODM CDISC ESUG Meeting Andrew Newbigging Vice President, Integrations Development 13 th July 2010 Medidata Solutions, Inc. Proprietary.
Defining & Managing Data Elements and Permissible Values or CDISC Terminology - A Use Case BACUN Barrie Nelson.
German Speaking CDISC UG, 22-Sep CDER Common Data Standards Issues Document Motivation CDISC submissions received varied more than expected Contents.
April ADaM define.xml - Metadata Design Analysis Results Metadata List of key analyses (as defined in change order) Analysis Results Metadata per.
With OpenCDISC Validator 1. What is 2 OpenCDISC Validator Open source project Freely Available Commercial-quality Facilitate compliance with CDISC standards.
© CDISC 2015 Paul Houston CDISC Europe Foundation Head of European Operations 1 CTR 2 Protocol Representation Implementation Model Clinical Trial Registration.
Basel, September 2, 2008 Work Stream Summary define.xml/eSubmissions.
Submission Standards: The Big Picture Gary G. Walker Associate Director, Programming Standards, Global Data Solutions, Global Data Management.
Paul Houston CDISC Europe Foundation Head of European Operations
Essential Needs of Software Test Automation
Dave Iberson-Hurst CDISC VP Technical Strategy
Leveraging R and Shiny for Point and Click ADaM Analysis
Validation of CDISC data sets, current practice and future
7. German CDISC User Group Meeting Define
define.xml/eSubmissions
Experience and process for collaborating with an outsource company to create the define file. Ganesh Sankaran TAKE Solutions.
The use of LOINC in CDISC Standards
Accelerate define.xml using defineReady - Saravanan June 17, 2015.
Beyond regulatory submission - Standards Metadata Management Kevin Lee CDISC NJ Meeting at 06/17/2015 We help our Clients deliver better outcomes, so.
Accenture Accelerated R&D Standards Metadata Management – version control and its governance Kevin Lee CDISC NJ Meeting at 01/28/2015 We help our Clients.
SDTM Work Stream Basel, September 2, 2008.
Monika Kawohl Statistical Programming Accovion GmbH
MAKE SDTM EASIER START WITH CDASH !
Quality Control of SDTM Domain Mappings from Electronic Case Report Forms Noga Meiry Lewin, MS Senior SAS Programmer The Emmes Corporation Target: 38th.
Study Data Reviewers’ Guide – Nonclinical Assessment
Software Development Process
CDISC UK Network Jun-16 – Welwyn
A SAS macro to check SDTM domains against controlled terminology
To change this title, go to Notes Master
Proposal for a procedure for adoption of INSPIRE good practices
SDTM and ADaM Implementation FAQ
German Speaking CDISC User Network
Monika Kawohl Statistical Programming Accovion GmbH
Research on FHIR Working Group Update
Generating Define.xml at Kendle using DefinedocTM
Standard Scripts Project 2
Establishment of German CDISC User Group: Discussion templates
Generating Define.xml at Kendle using DefinedocTM
SDTM Work Stream Basel, September 2, 2008.
Emerging Technologies
CLINICAL DATA ANALYST INTERNSHIP, AT DATAPLUS PHARMA SERVICES
Optimzing the Use of Data Standards Calling for Volunteers
German Speaking CDISC User Network
Presentation transcript:

Work Stream Templates Basel, September 2, 2008

CDISC User Group Work Streams Goals Sharing of expertise and knowledge Sharing of useful tools (e.g. Stylesheets, ODM vendor extensions, SAS macros) Joint mock eSubmission Test new CDISC models and provide joint feedback Identification of implementation examples Case studies Best practices document Identification of implementation issues Discussion of implementation issues and proposal of joint solutions / implementation approaches Case studies, FAQs New requirements Requirements document (e.g. stylesheet improvements, new SDTM domains) Goals 2009 What do we want to achieve? Meeting schedules of work streams

CDISC User Group Work Streams Some considerations for discussion ODM Work Stream: ODM-based archival concept CDASH integration SDTM Work Stream: Proposal of new domains ADaM Work Stream: (Automated) generation of ADaM datasets from SDTM Macros Define.xml Work Stream: Stylesheet improvements Executable expressions

CDISC User Group Work Streams Sharing of expterise and knowledge

CDISC User Group Work Streams Identification of implementation examples

CDISC User Group Work Streams Identification of implementation issues

CDISC User Group Work Streams New requirements

CDISC User Group Work Streams Goals 2009