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PhUSE proceedings: CDISC, 127 papers

Pharmaceutical Users Software Exchange 2016   October 9-12, 2016 - Barcelona, Spain

CDISC and Industry Standards
tweet!  Protocol Representation: The Forgotten CDISC Model
  Jeffrey Abolafia, Rho Inc., Chapel Hill, NC USA; Frank DiIorio, CodeCrafters, Inc., Philadelphia PA USA
Keywords: PRM Protocol CDISC Metadata
Pages: 10 Size: 272 Kb    Download the presentationdownload (.pdf, 10416 Kb)
CDASHIG V2.0: What is it Good For?
  Éanna Kiely, CDISC Engineer, Inventiv Health
  Download the presentationdownload (.pdf, 2425 Kb)
tweet!  DIY: Create your own SDTM mapping framework
  Bas van Bakel, OCS Consulting, ‘s-Hertogenbosch, the Netherlands
Keywords: SDTM Mapping framework CDISC
Pages: 11 Size: 698 Kb    Download the presentationdownload (.pdf, 1155 Kb)
tweet!  Assessing CDISC Therapeutic Area User Guides in a machine readable format
  Johannes Ulander, S-Cubed, Copenhagen, Denmark; Niels Both, S-Cubed, Copenhagen, Denmark
Keywords: CDISC
Pages: 4 Size: 308 Kb    Download the presentationdownload (.pdf, 1396 Kb)
tweet!  Device Domains: Examples of their Use in Clinical Trials
  Oksana Voevutska, Chiltern, Kyiv, Ukraine
Keywords: Device Domains SDTM SDTMIG-MD clinical
Pages: 12 Size: 453 Kb    Download the presentationdownload (.pdf, 3307 Kb)
tweet!  Analysis Datasets for Baseline Characteristics and Exposure Time for Multi-stage Clinical Trials
  Kimberly Umans, Biogen, Cambridge, USA; Katherine Riester, Biogen, Cambridge, USA; Manjit McNeill, Biogen, Maidenhead, UK; Wei Liu, Biogen, Cambridge, USA; Lukasz Kniola, Biogen, Maidenhead, UK
Keywords: ADaM CDISC dataset baseline clinical
Pages: 5 Size: 55 Kb    Download the presentationdownload (.pdf, 935 Kb)
tweet!  OCCDS – Creating flags or records
  Rob Wartenhorst, GSK Vaccines, Amsterdam, Netherlands
Pages: 4 Size: 123 Kb    Download the presentationdownload (.pdf, 829 Kb)
tweet!  Increasing Work Group Transparency: ADaMIG v1.2 Update and New Team Working Process Review
  Terek J. Peterson, MBA, Chiltern, King of Prussia, PA, USA; Brian Harris, MedImmune, Gaithersburg, MD, USA
Pages: 8 Size: 761 Kb    Download the presentationdownload (.pdf, 1492 Kb)
Constructing A Data Warehouse For Nutrition Clinical Studies
  Paul Vervuren, Danone Nutricia Research, Utrecht, The Netherlands
Keywords: clinical warehouse
  Download the presentationdownload (.pdf, 2464 Kb)
tweet!  Linking Metadata from CDASH to ADaM
  João Gonçalves, Business & Decision Life Sciences, Brussels, Belgium
Keywords: PhUSE Conference
Pages: 6 Size: 505 Kb    Download the presentationdownload (.pdf, 2072 Kb)
Best Presentation
tweet!  Analysis Result Metadata… are we there yet?
  Carla Santillan, Chiltern International BVBA, Heverlee, Belgium
Keywords: Analysis Result Metadata ADaM metadata
Pages: 10 Size: 551 Kb    Download the presentationdownload (.pdf, 1519 Kb)
tweet!  Pattern based Metadata Repository: Toward high quality data standards
  Alan Cantrell, PAREXEL®, Sheffield, United Kingdom; Julius Kusserow, PAREXEL®, Berlin, Germany; Julie James PAREXEL® Informatics, Nottingham, United Kingdom; Deb Copeland, PAREXEL®, Durham, North Carolina, USA; Natraj Patro, PAREXEL®, Billerica, Massachusetts, USA; Isabelle de Zegher, PAREXEL® Informatics, Wavre, Belgium
Pages: 7 Size: 585 Kb    Download the presentationdownload (.pdf, 1698 Kb)
To Create define.xml using .XML and OpenCDISC Validator
  Murali Neela, GCE solutions, India
Keywords: CDISC xml
  Download the presentationdownload (.pdf, 4547 Kb)
tweet!  Out-of-the-box %defineXML – Just a Simple SAS Macro
  Katja Glaß, Bayer Pharma AG, Berlin, Germany
Keywords: macro xml
Pages: 11 Size: 941 Kb    Download the presentationdownload (.pdf, 4530 Kb)
tweet!  How to handle different versions of SDTM & DEFINE generation in a Single Study?
  Edwin Ponraj Thangarajan, PRA Health Sciences, Chennai, India; Giri Balasubramanian, PRA Health Sciences, Chennai, India
Keywords: CDISC SDTM Define-XML Data Standards EXACT
Pages: 22 Size: 3569 Kb    Download the presentationdownload (.pdf, 8735 Kb)
A Moratorium on the Standards Madness
  Scott Bahlavooni, d-Wise, Morrisville, NC, USA
  Download the presentationdownload (.pdf, 4632 Kb)
tweet!  Understanding the potential of Share: a visual business case and technical use case
  Peter Van Reusel, Business & Decision Life Sciences, Brussels, Belgium
Pages: 4 Size: 136 Kb    Download the presentationdownload (.pdf, 17216 Kb)

Pharmaceutical Users Software Exchange 2015   October 11-14, 2015 - Vienna, Austria

CDISC and Industry Standards
tweet!  Introduction to CDISC BRIDG
  Joerg Dillert, Oracle
Keywords: CDISC
Pages: 11 Size: 2053 Kb    Download the presentationdownload (.pdf, 8399 Kb)
tweet!  Are Your Ready for SEND?
  Roman Radelicki, SGS Life Sciences Services
Keywords: SEND implementation
Pages: 8 Size: 301 Kb    Download the presentationdownload (.pdf, 999 Kb)
tweet!  Therapeutic Area Standards and their Impact on Current SDTM Implementations
  Johannes Ulander, S-cubed; Niels Both, S-cubed
Keywords: TAUG CDISC Medical History MHCAT
Pages: 6 Size: 442 Kb    Download the presentationdownload (.pdf, 11795 Kb)
Best Presentation
tweet!  Access to CDISC SHARE Metadata: A La Cate, Prix Fixe or Table d'Horte?
  Ken Stoltzfus, Accenture
Keywords: CDISC standards metadata MDR SHARE
Pages: 9 Size: 539 Kb    Download the presentationdownload (.pdf, 8029 Kb)
tweet!  Managing Data Standards Libraries Compliance (to CDISC)
  Deborah Paletta, Business & Decision Life Sciences
Keywords: CDISC
Pages: 7 Size: 218 Kb    Download the presentationdownload (.pdf, 4364 Kb)
tweet!  A Model for Reviewing the Operational Implementation of the CDISC Standards
  Andy Richardson, d-Wise
Keywords: CDISC
Pages: 7 Size: 989 Kb    Download the presentationdownload (.pdf, 2688 Kb)
tweet!  Data Governance - Keeping Control through a Well-defined Changes Request Process
  Gavin Winpenny, Business & Decision Life Sciences
Keywords: PhUSE Conference
Pages: 9 Size: 1229 Kb    Download the presentationdownload (.pdf, 4241 Kb)
tweet!  Improving CDISC SDTM Data Quality & Compliance Right from the Beginning
  Bharat Chaudhary, Cytel; Padamsimh Balekundri, Cytel
Keywords: Check SDTM Data Quality & Compliance CDISC
Pages: 9 Size: 438 Kb    Download the presentationdownload (.pdf, 9823 Kb)
tweet!  Managing ADaM Metadata
  Ann Fitzherbert, GlaxoSmithKline; Khilit Shah, GlaxoSmithKline
Pages: 6 Size: 286 Kb    Download the presentationdownload (.pdf, 1743 Kb)
tweet!  ADaM - Our Experience
  Rob Wartenhorst, GlaxoSmithKline
Pages: 5 Size: 175 Kb    Download the presentationdownload (.pdf, 696 Kb)
tweet!  Dataset-XML - A New CDISC Standard for Data Exchange
  Julie Maddox, SAS Institute; Lex Jansen, SAS Institute
Keywords: SAS CST CDISC Dataset-XML Define-XML define.xml metadata
Pages: 16 Size: 808 Kb    Download the presentationdownload (.pdf, 6929 Kb)
tweet!  Results-level Metadata: What, How and Why
  Frank DiIorio, CodeCrafters; Jeff Abolafia, Rho
Keywords: results metadata ARM define.xml metadata FDA electronic submissions CDISC ADaM metadata ADaM XML XSL analysis results metadata
Pages: 11 Size: 482 Kb    Download the presentationdownload (.pdf, 2615 Kb)
tweet!  ADaM Reviewer's Guide - Interpretation and Implementation
  Steve Griffiths, GlaxoSmithKlilne
Keywords: ADaM Reviewer Interpretation
Pages: 5 Size: 53 Kb    Download the presentationdownload (.pdf, 1685 Kb)

Pharmaceutical Users Software Exchange 2014   October 12-15, 2014 - London, United Kingdom

CDISC and Industry Standards
tweet!  Challenges with the Interpretation of CDISC - Who Can We Trust?
  Linda Palm Simonsson, I-Mind
Keywords: CDISC SDTM ADaM FDA implementation
Pages: 10 Size: 695 Kb    Download the presentationdownload (.pdf, 983 Kb)
tweet!  Findings About: "Findings About"
  Madhura Khare, Cytel
Pages: 8 Size: 225 Kb    Download the presentationdownload (.pdf, 683 Kb)
Best Presentation
tweet!  ADaM Standards: What's New?
  Gavin Winpenny, Business & Decision Life Sciences
Pages: 9 Size: 1669 Kb    Download the presentationdownload (.pptx, 2783 Kb)
tweet!  How the Release of the Therapeutic Area Asthma User Guide Affects an Ongoing Submission
  Nick De Donder, Business & Decision Life Sciences
Pages: 6 Size: 73 Kb    Download the presentationdownload (.pptx, 2440 Kb)
tweet!  Handling Non-Standardised Questionnaires
  Anne-Sophie Bekx, Business & Decision Life Sciences; Éanna Kiely, Business & Decision Life Sciences
Pages: 5 Size: 148 Kb    Download the presentationdownload (.pptx, 2902 Kb)
tweet!  Implementation of CDISC ADaM in the Pharmacokinetics Department
  Joanna Magielse, SGS Life Sciences Services; Tineke Callant, SGS Life Sciences Services; Elke Vansnick, SGS Life Sciences Services
Keywords: CDISC ADaM PK
Pages: 6 Size: 297 Kb    Download the presentationdownload (.pdf, 1599 Kb)
tweet!  Is Your Clinical Data Standards Library Ready for Change? Adapting to TA Specific Standards
  Lauren Shinaberry, Business & Decision Life Sciences
Keywords: PhUSE Conference clinical
Pages: 6 Size: 924 Kb    Download the presentationdownload (.pdf, 3626 Kb)
tweet!  Models, Metadata and Messaging: Exploring Standards Governance in the CDISC Era
  Ken Stoltzfus, Accenture Life Sciences
Keywords: CDISC standards governance metadata MDR
Pages: 6 Size: 222 Kb    Download the presentationdownload (.pdf, 3144 Kb)
Successfully Embracing Challenges to CDISC Standards
  Elke Sennewald, Theorem Clinical Research
Keywords: CDISC
  Download the presentationdownload (.pptx, 1840 Kb)
tweet!  Every Study is Special! - Governing Data Standards
  Chris Price, Roche; Elizabeth Nicol, Genentech
Keywords: CDISC SDTM ADaM Governance
Pages: 12 Size: 930 Kb    Download the presentationdownload (.pdf, 1367 Kb)
tweet!  Using CDISC Validation Tools in a Validated Hosted Environment
  Sandeep Juneja, SAS Institute
Keywords: CDISC
Pages: 5 Size: 499 Kb    Download the presentationdownload (.pdf, 4995 Kb)
tweet!  Discover Define.xml
  Mark Wheeldon, Formedix
Keywords: Define-XML End-to-End Clinical Trials Datasets CDISC
Pages: 12 Size: 1260 Kb    Download the presentationdownload (.pdf, 2731 Kb)
tweet!  Looking for SDTM Migration Specialist
  Angelo Tinazzi, Cytel
Keywords: CDISC SDTM Legacy Studies
Pages: 12 Size: 511 Kb    Download the presentationdownload (.pdf, 3245 Kb)
tweet!  Considerations in Creating Transparent SDTM-Based Datasets
  Jerry Salyers, Accenture Life Sciences; Richard Lewis, Accenture Life Sciences; Fred Wood, Accenture Life Sciences
Keywords: Data Transparency Traceability SDTM CDISC
Pages: 8 Size: 103 Kb    Download the presentationdownload (.pdf, 701 Kb)   Download the presentationdownload (.pptx, 961 Kb)
tweet!  CDISC Dataset-XML - A Dataset Structure for Clinical Trial Data Transport for Future Drug Submissions
  Joerg Dillert, Oracle
Keywords: CDISC xml clinical
Pages: 6 Size: 471 Kb    Download the presentationdownload (.pdf, 4505 Kb)

Pharmaceutical Users Software Exchange 2013   October 13-16, 2013 - Brussels, Belgium

CDISC and Industry Standards
tweet!  Interpreting CDISC ADaM IG Through Users Interpretation
  Angelo Tinazzi, Cytel
Keywords: CDISC
Pages: 12 Size: 334 Kb    Download the presentationdownload (.pdf, 1948 Kb)
Best Presentation
tweet!  ADaM Standards - Organising the Unorganised
  Heike Reichert, Bayer Pharma AG
Keywords: ADaM Standardization Standards Analysis dataset
Pages: 7 Size: 615 Kb    Download the presentationdownload (.pdf, 3173 Kb)
tweet!  Round Trip Ticket -Using the Define.xml file to Send and Receive your Study Specifications
  Julie Maddox, SAS Institute
Keywords: CRT-DDS DEFINE.XML SAS Clinical Data Integration SAS Clinical Standards Toolkit
Pages: 10 Size: 399 Kb    Download the presentationdownload (.pdf, 1632 Kb)
tweet!  HL7 RIM - An Introduction for Non-Technical Professionals
  Joerg Dillert, Oracle
Pages: 6 Size: 2191 Kb    Download the presentationdownload (.pdf, 6506 Kb)
tweet!  Define-XML v2 - What's New
  Lex Jansen, SAS Institute
Keywords: CDISC CRT-DDS Define-XML define.xml metadata
Pages: 15 Size: 371 Kb    Download the presentationdownload (.pdf, 2265 Kb)
tweet!  Standards Governance - A First Insight
  Claudia Meurer, Merck Serono
Keywords: Standards Governance Process SDTM Exemption handling
Pages: 6 Size: 165 Kb    Download the presentationdownload (.pdf, 1561 Kb)
Standard Protocols Using Guided Navigation
  Michaela Jahn, F. Hoffman-La Roche
  Download the presentationdownload (.pdf, 617 Kb)
tweet!  ADaM Datasets - Standard and Submission Ready
  Karin Fleischer Steffensen, Ferring Pharmarceuticals
Pages: 6 Size: 231 Kb    Download the presentationdownload (.pdf, 1312 Kb)
tweet!  Interpretation of the Output from the OpenCDISC Checker
  Joergen Iversen, LEO Pharma A/S
Keywords: CDISC
Pages: 5 Size: 103 Kb    Download the presentationdownload (.pdf, 727 Kb)
tweet!  The Evolution of SDTM - What's New
  Tina Apers, Business & Decision Life Sciences
Keywords: CDISC
Pages: 5 Size: 2900 Kb    Download the presentationdownload (.pdf, 9670 Kb)
tweet!  Considerations in the Submission of Holter (EG) Data in an SDTM Compliant Format
  Elsa Lozachmeur, Novartis; Sophie Arnould, Novartis; Joseph Rowley, Novartis
Keywords: CDISC
Pages: 7 Size: 100 Kb    Download the presentationdownload (.pdf, 846 Kb)
tweet!  The Missing Link: Results Level Metadata
  Jeff Abolafia, Rho
Keywords: Metadata Define File Results Analysis
Pages: 9 Size: 392 Kb    Download the presentationdownload (.pdf, 10882 Kb)
tweet!  SDTM Oncology Domains: From Patient to Data to Narrative
  Kenneth Stoltzfus, Accenture
Keywords: CDISC SDTM Oncology
Pages: 4 Size: 134 Kb    Download the presentationdownload (.pdf, 4381 Kb)
tweet!  Is your Library a Success: Manage & Measure Conformance Across Partners and Projects
  Lauren Shinaberry, Business & Decision Life Sciences; Bart Van Win, Business & Decision Life Sciences
Pages: 4 Size: 1936 Kb    Download the presentationdownload (.pdf, 2399 Kb)

Pharmaceutical Users Software Exchange 2012   October 14-17, 2012 - Budapest, Hungary

CDISC and Industry Standards
tweet!  ADaM Or SDTM? A Comparision of Pooling Strategies for Integrated Analyses in the Age of CDISC
  Joerg Guettner, Bayer Pharma AG; Alexandru Cuza, UCB BioSciencdes GmbH
Keywords: CDISC
Pages: 7 Size: 586 Kb    Download the presentationdownload (.pdf, 1180 Kb)
tweet!  Mapping the Company's Legacy Data Model to SDTM
  Anja Feuerbacher, F. Hoffman-La Roche; Nicolas Dupuis, F. Hoffman-La Roche; Bruce Rogers, F. Hoffman-La Roche
Keywords: CDISC
Pages: 7 Size: 454 Kb    Download the presentationdownload (.pdf, 422 Kb)
tweet!  SAS® Clinical Standards Toolkit: define.xml and Value Level Metadata
  Lex Jansen, SAS Institute; Presented by Gene Lightfoot, SAS Institute Inc
Keywords: define.xml CDISC SDTM SAS clinical
Pages: 27 Size: 1418 Kb    Download the presentationdownload (.pdf, 3420 Kb)
Best Presentation
tweet!  Interpreting ADaM Standards with OpenCDISC
  Trupti Bal, Cytel Statistical Software & Services Pvt. Ltd; Madhura Paranjape, Cytel Statistical Software & Services Pvt. Ltd
Keywords: ADaM OpenCDISC
Pages: 8 Size: 252 Kb    Download the presentationdownload (.pdf, 5022 Kb)
tweet!  Considerations for CSR Output Production from ADaM Datasets
  Andrew Noller, Quintiles
Pages: 1 Size: 89 Kb    Download the presentationdownload (.pdf, 1541 Kb)
tweet!  Real-World Application of the Protocol Representations Model
  Joshua Pines, Medidata Solutions; Michelle Marlborough, Medidata Solutions
Pages: 1 Size: 48 Kb    Download the presentationdownload (.pdf, 2032 Kb)
tweet!  SDTM and AdaM: Metadata Playing Together Nicely
  Kenneth Stoltzfus, Octagon Research Solutions
Keywords: CDISC SDTM ADaM metadata MDR
Pages: 7 Size: 269 Kb    Download the presentationdownload (.pdf, 3032 Kb)
tweet!  Approaches to Creating ADaM Subject-Level Analysis Datasets (ADSL) for Integrated Analyses
  Thomas Cinch, Theorem Clinical Research; Nate Freimark, Theorem Clinical Research
Pages: 6 Size: 115 Kb    Download the presentationdownload (.pdf, 326 Kb)
tweet!  CDISC Advisory Board Validation Project - Best Practices for CDISC Validation Rules
  Lauren Shinaberry, Business & Decision Life Sciences
Keywords: SDTM validation rules CAB CDISC
Pages: 4 Size: 76 Kb    Download the presentationdownload (.pdf, 3482 Kb)

Pharmaceutical Users Software Exchange 2011   October 9-12, 2011 - Brighton, United Kingdom

CDISC and Industry Standards
tweet!  ADaM Validation and Integrity Checks
  Louise Cross, ICON Clinical Research
Pages: 5 Size: 114 Kb    Download the presentationdownload (.ppt, 1200 Kb)
tweet!  SDTM Implementation Guide - Clear as Mud: Strategies for Developing Consistent Company Standards
  Brian Mabe, UCB BioSciences Inc
Keywords: CDISC
Pages: 5 Size: 253 Kb    Download the presentationdownload (.ppt, 928 Kb)
tweet!  Three Unique Case Studies - On the Trail of the Holy Grail of SDTM Implementation
  Kenneth Stoltzfus, Octagon Research Solutions
Keywords: CDISC SDTM mapping implementation governance
Pages: 6 Size: 82 Kb    Download the presentationdownload (.ppt, 1651 Kb)
tweet!  Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies - an ICON Approach
  Jennie McGuirk, ICON Clinical Research; Steven Thacker, ICON Clinical Research
Keywords: CDISC
Pages: 16 Size: 453 Kb    Download the presentationdownload (.ppt, 1579 Kb)
tweet!  SDTM Domain QS: Challenges and Pitfalls - an Interpretation Guide to the Implementation Guide
  Knut Mueller, UCB BioSciences
Keywords: CDISC
Pages: 6 Size: 100 Kb    Download the presentationdownload (.ppt, 2930 Kb)
tweet!  Using the SAS® Clinical Standards Toolkit to work with the CDISC ODM model
  Lex Jansen, SAS Institute Inc
Keywords: SAS CDISC ODM XML SAS® Clinical Standards Toolkit
Pages: 20 Size: 627 Kb    Download the presentationdownload (.ppt, 3529 Kb)
tweet!  SAS Drug Development as a platform governing data standards specification and clinical data exchange
  Mark Lambrecht, SAS; Peter Van Reusel, Business & Decision Life Sciences
Keywords: SAS Drug Development standards CDISC workflow library clinical
Pages: 9 Size: 402 Kb 
Best Presentation
tweet!  Tracing data elements through a standard data flow
  Alistair Dootson, Dootsonic
Keywords: CDISC Traceability SDTM ADaM CDASH Metadata ETL TFLs
Pages: 13 Size: 455 Kb    Download the presentationdownload (.ppt, 1537 Kb)
tweet!  Defining the Governance and Process of Implementing ADaM across an Organization
  Chris Decker, d-Wise Technologies
Pages: 11 Size: 298 Kb    Download the presentationdownload (.ppt, 1591 Kb)
tweet!  Creating ADaM Friendly Analysis Data from SDTM Using Meta Data
  Erik Brun, H. Lundbeck A/S; Rico Schiller, H. Lundbeck A/S
Keywords: CDISC ADaM SDTM analysis datasets metadata generated
Pages: 6 Size: 527 Kb    Download the presentationdownload (.ppt, 1748 Kb)
tweet!  ADaM on a diet: preventing wide and heavy analysis datasets
  Dirk Van Krunckelsven, Merck Serono International S.A
Pages: 5 Size: 191 Kb    Download the presentationdownload (.ppt, 728 Kb)

Pharmaceutical Users Software Exchange 2010   October 14-17, 2010 - Berlin, Germany

CDISC and Industry Standards
tweet!  Initial Investment in CDISC Data Standards in Clinical Organisations
  Kenneth Stoltzfus, Octagon Research Solutions
Keywords: governance standards people processes technical solutions CDISC clinical
Pages: 10 Size: 60 Kb    Download the presentationdownload (.ppt, 1728 Kb)
tweet!  How Do I Map That? - SDTM Implementation Challenges
  Chris Price, Roche Products Ltd
Keywords: CDISC SDTM Legacy
Pages: 11 Size: 208 Kb    Download the presentationdownload (.ppt, 814 Kb)
tweet!  From ACE to ZINC
  Paul Vervuren, MSD/NV Organon
Keywords: CDISC SDTM lab test controlled terminology LBTEST LBTESTCD
Pages: 8 Size: 439 Kb 
New CDISC migration strategies and tools: determining the best approach and employing automated data mapping
  Michael Weitz, Cytel; Lauren Spiess, Cytel
Keywords: CDISC
  Download the presentationdownload (.ppt, 1237 Kb)
tweet!  How to go From an SDTM Findings Domain to an ADaM-Compliant Analysis Dataset: An Example
  Carl Herremans, Merck Sharp & Dohme (Europe)
Keywords: CDISC
Pages: 8 Size: 51 Kb    Download the presentationdownload (.ppt, 856 Kb)
tweet!  Traceability between SDTM and ADaM converted analysis datasets
  Florence Somers, Business & Decision Life Sciences; Michael Knoessl, Boehringer Ingelheim Pharma GmbH & Co. KG
Keywords: CDISC ADaM Traceability Quality Control
Pages: 7 Size: 187 Kb    Download the presentationdownload (.ppt, 5335 Kb)
tweet!  Defining "Compliance" for Analysis Data
  Chris Decker, d-Wise Technologies; Randall Austin, GlaxoSmithKline
Pages: 7 Size: 294 Kb    Download the presentationdownload (.ppt, 1021 Kb)
tweet!  The Use of Meta Data in Creating, Transforming and Transporting Clinical Data
  Gregory Steffens, ICON
Keywords: clinical
Pages: 9 Size: 79 Kb    Download the presentationdownload (.ppt, 246 Kb)
tweet!  Define.xml - Tips and Techniques for Creating CRT-DDS
  Julie Maddox, SAS Institute; Mark Lambrecht, SAS Institute
Keywords: CRT-DDS DEFINE.XML SAS Clinical Data Integration
Pages: 10 Size: 226 Kb    Download the presentationdownload (.ppt, 6857 Kb)
tweet!  Accessing the metadata from the define.xml using XSLT transformations
  Lex Jansen, Octagon Research Solutions
Keywords: define.xml CDISC SDTM SAS XML Mapper XSLT
Pages: 24 Size: 984 Kb    Download the presentationdownload (.ppt, 2151 Kb)
tweet!  Bridging the communication gap: implementing metadata standards in trial protocols
  Annabel Acs, Novo Nordisk
Pages: 7 Size: 136 Kb    Download the presentationdownload (.ppt, 641 Kb)
tweet!  CDISC integration in a clinical data management system
  Peter Van Reusel, Business & Decision Life Sciences
Keywords: CDISC SDTM Oracle Clinical Remote Data Capture
Pages: 13 Size: 314 Kb    Download the presentationdownload (.ppt, 6009 Kb)
tweet!  Implementing, Managing and Validating a Clinical Standard
  Gene Lightfoot, SAS Institute
Keywords: clinical
Pages: 12 Size: 574 Kb    Download the presentationdownload (.ppt, 1785 Kb)

Pharmaceutical Users Software Exchange 2009   October 19-21, 2009 - Basel, Switzerland

CDISC and Industry Standards
tweet!  SDTM Validation: How can we do it right?
  Peter Van Reusel, Business & Decision Life Sciences
Keywords: CDISC SDTM Validation
Pages: 8 Size: 854 Kb    Download the presentationdownload (.pdf, 1326 Kb)
tweet!  Generate Define.xml & Define.pdf from Metadata Environment
  Rohit Banga, Business & Decision Life Sciences
Keywords: Define Define.xml Define.pdf CDISC SDTM ODM Metadata
Pages: 11 Size: 246 Kb    Download the presentationdownload (.pdf, 1346 Kb)
tweet!  An Evaluation of the ADaM Implementation Guide v1.0 and the Analysis Data Mode v2.1
  Chris Price, Roche
Pages: 4 Size: 33 Kb    Download the presentationdownload (.pdf, 159 Kb)
tweet!  Insights into ADaM
  Matthew Becker, PharmaNet
Keywords: ADaM analysis metadata ADSL
Pages: 9 Size: 526 Kb    Download the presentationdownload (.pdf, 832 Kb)
tweet!  Using SAS Clinical Data Integration Server to Implement and Manage CDISC Standards
  Julie Maddox, SAS Institute
Keywords: CDISC clinical
Pages: 8 Size: 433 Kb    Download the presentationdownload (.pdf, 822 Kb)
tweet!  The SAS Clinical Standards Toolkit
  David Smith, SAS Institute
Keywords: clinical
Pages: 8 Size: 2464 Kb    Download the presentationdownload (.pdf, 1541 Kb)
Best Presentation
tweet!  The CDISC/FDA Integrated Data Pilot: A Case Study in Implementing CDISC Standards to support an Integrated Review
  Chris Decker, d-Wise Technologies
Keywords: CDISC FDA SDTM ADaM Standards Integration
Pages: 15 Size: 218 Kb    Download the presentationdownload (.pdf, 476 Kb)
tweet!  From raw data to submission: A metadata-driven, repository-based process of data conversion to CDISC
  Dimitri Kutsenko, Entimo
Keywords: CDISC SDTM define.xml conversion mapping legacy metadata repository
Pages: 7 Size: 427 Kb    Download the presentationdownload (.pdf, 161 Kb)
Standardization of data base: interaction between Biostatistics and Clinical Data Management
  Céline Tendero, Sanof-Aventis
Keywords: clinical
  Download the presentationdownload (.pdf, 73 Kb)
tweet!  Converting the define.xml to a Relational Database to Enable Printing and Validation
  Lex Jansen, Octagon Research Solutions
Keywords: define.xml CDISC SDTM SAS XML Mapper PDF
Pages: 19 Size: 888 Kb    Download the presentationdownload (.pdf, 2158 Kb)
tweet!  Using SAS Macros to simplify preparation and validation of SDTM data, Annotated CRFs and Define.xml in a metadata driven environment
  Niels Both, S-cubed
Pages: 10 Size: 516 Kb    Download the presentationdownload (.pdf, 313 Kb)
Kendle Implementation of CDASH
  Elke Sennewald, Kendle; Gill Lawrence, Kendle
  Download the presentationdownload (.pdf, 635 Kb)
tweet!  Implementation of ADaM standards NOT driven by a submission
  Karin Fleischer, Ferring Pharmaceuticals
Pages: 7 Size: 222 Kb    Download the presentationdownload (.pdf, 199 Kb)
tweet!  Experiences and lessons learned from a first SDTM submission project
  Paul Vervuren, Schering-Plough; Bas van Bakel, OCS Consulting
Keywords: CDISC SDTM submission late-stage conversion define.xml WebSDM
Pages: 12 Size: 491 Kb    Download the presentationdownload (.pdf, 619 Kb)

Pharmaceutical Users Software Exchange 2008   October 12-15, 2008 - Manchester, United Kingdom

tweet!  The application of SDTM in a disease (oncology)-oriented organization
  Angelo Tinazzi, SENDO-Tech S.r.l ; Alessandro Cattaneo, SENDO-Tech S.r.l ; Enrica Paschetto, SENDO-Tech S.r.l ; Sonia Colombini, SENDO-Tech S.r.l
Keywords: CDISC
Pages: 8 Size: 510 Kb 
tweet!  CDISC Implementation Strategies: Exploit your data assets while still giving the FDA what they want
  David Smith, SAS Institute
Keywords: CDISC
Pages: 9 Size: 517 Kb 
tweet!  Implementing CDISC at Boehringer Ingelheim
  Michael Knoessl, Boehringer Ingelheim; Peter Leister, IBM
Keywords: CDISC SDTM Clinical Data Model Boehringer Ingelheim
Pages: 5 Size: 61 Kb 
Best Presentation
tweet!  Using the SAS® XML Mapper and ODS to create a PDF representation of the define.xml
  Lex Jansen, Octagon Research Solutions
Keywords: define.xml CDISC SDTM SAS XML Mapper PDF
Pages: 21 Size: 1258 Kb    Download the presentationdownload (.pdf, 2779 Kb)
tweet!  In at the Deep-End (thoughts on mapping multiple studies into CDISC for an ISS/ISE)
  Andrew Noller, Quintiles
Keywords: CDISC ISS/ ISE
Pages: 7 Size: 170 Kb 
CDISC - an overview, How far have we come, where are we going and what is the next step
  Ann-Sofie Bergstrom, SAS Institute
Keywords: CDISC
CDISC SDTM, ADaM and Metadata : Connecting the Standards
  Joel Hoffman, Waban Software
Keywords: CDISC
tweet!  CDISC: Implementation Strategies for SDTM
  Brian Mabe, UCB Pharma
Keywords: SAS autocall alias macro library versioning CDISC
Pages: 5 Size: 133 Kb 

Pharmaceutical Users Software Exchange 2005   October 10-12, 2005 - Heidelberg, Germany

tweet!  An Introduction to CDISC - What is CDISC and Why Standards?
  Laurie Rose, SAS Institute; Becky Kush, CDISC
Keywords: CDISC
Pages: 41 Size: 1223 Kb 
tweet!  An Introduction to CDISC - Available CDISC Standards and Models and How SAS Supports These
  Laurie Rose, SAS Institute
Keywords: CDISC
Pages: 43 Size: 1612 Kb 
tweet!  An Introduction to CDISC - CDISC Collaborations and Standards in Progress
  Becky Kush, CDISC
Keywords: CDISC
Pages: 46 Size: 1531 Kb 
tweet!  Best Practices for Managing Clinical Research Information
  Dave Handelsman, SAS Institute
Keywords: clinical
Pages: 16 Size: 1490 Kb 
tweet!  Pharmacovigilance Using SAS Technology , Analytics and CDISC Data Standards, including the SDTM-ADaM Submission Relationship
  Ed Helton, SAS Institute
Keywords: CDISC
Pages: 39 Size: 1498 Kb 
tweet!  What SAS is doing for the FDA's Critical Path Initiative?
  Andrew Fagan, SAS Institute
Pages: 20 Size: 557 Kb 
tweet!  ODM & define.xml
  Dave Iberson-Hurst, Assero Limited
Keywords: xml
Pages: 58 Size: 924 Kb 
tweet!  SAS Dataset Content Conversion to CDISC Data Standards
  Tony Friebel, SAS Institute
Keywords: CDISC
Pages: 9 Size: 270 Kb 
tweet!  Software Tools for working with CDISC ODM, SDTM, LAB and define.xml
  Jozef Aerts, XML4Pharma
Keywords: CDISC xml
Pages: 2 Size: 33 Kb    Download the presentationdownload (.pdf, 150 Kb)
Best Presentation
tweet!  Customer oriented CDISC implementation
  Edelbert Arnold, Accovion GmbH; Ulrike Plank, Accovion GmbH
Keywords: CDISC SDTM ADaM define.xml Implementation
Pages: 13 Size: 233 Kb    Download the presentationdownload (.pdf, 243 Kb)
tweet!  Mapping Corporate Data Standards to the CDISC Model
  David Parker, Astra Zeneca
Keywords: CDISC
Pages: 7 Size: 296 Kb    Download the presentationdownload (.pdf, 1203 Kb)
tweet!  The Future of CDISC
  Becky Kush, CDISC
Keywords: CDISC
Pages: 50 Size: 1046 Kb    Download the presentationdownload (.ppt, 4144 Kb)
tweet!  CDISC Activities in Europe
  Udo Siegmann, Parexel International
Keywords: CDISC
Pages: 15 Size: 310 Kb 
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