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811 SAS proceeding papers related to CDISC


SouthEast SAS Users Group 2016

tweet!  Converting Non-Imputed Partial Dates (for SDTM Data Sets) Using PROC FCMP
  Noory Kim
Pages: 8 Size: 199 Kb 
tweet!  SDTM What? ADaM Who? A Programmer's Introduction to CDISC
  Venita DePuy
Pages: 9 Size: 409 Kb 

Midwest SAS Users Group 2016

tweet!  Pre-Data Checks for SDTM Development
  Abhinav Srivastva, PaxVax Inc., Redwood City, CA
Keywords: Pre-data checks, edit checks, clinical data quality checks, CDISC SDTM data checks, types of clinical data quality checks.
Pages: 10 Size: 122 Kb 

Pharmaceutical Users Software Exchange 2016

tweet!  QC of SDTM and aCRF using SAS
  Rune Østergaard Pedersen, S-Cubed, Copenhagen, Denmark; Niels Both, S-Cubed, Copenhagen, Denmark
Keywords: CDISC
Pages: 12 Size: 98 Kb    Download the presentationdownload (.pdf, 552 Kb)
tweet!  How to create your Define.xml as early as possible with a click on a button
  Roman Radelicki, SGS - Agriculture, Food and Life, Life Sciences - Clinical Research, Mechelen, Belgium
Keywords: define.xml, MDR, metadata repository
Pages: 7 Size: 480 Kb    Download the presentationdownload (.pdf, 1557 Kb)
What's New in CDISC
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
Keywords: CDISC
  Download the presentationdownload (.pdf, 4980 Kb)
Exercise: Define v2.0 and the Need for Value Level Metadata
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
  Download the presentationdownload (.pdf, 1586 Kb)
Standards Conceptual Model - Understanding the potential of Share
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
  Download the presentationdownload (.pdf, 16044 Kb)
Live Demo
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
  Download the demodownload (.mp4, 31043 Kb)
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
Keywords: PAREXEL CLINICAL MDR
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)
tweet!  Data De-Identification Made Simple
  Jørgen Mangor Iversen, LEO Pharma A/S, Ballerup, Denmark
Keywords: De-Identification;redaction
Pages: 6 Size: 198 Kb    Download the presentationdownload (.pdf, 1143 Kb)
Integrating the New EMA Requirements on Public Disclosure in the Study Conduct
  Jean-Marc Ferran, Qualiance
  Download the presentationdownload (.pdf, 6363 Kb)
tweet!  How a Metadata Repository enables dynamism and automation in SDTM-like dataset generation
  Judith Goud, Akana, Bennekom, The Netherlands; Priya Shetty, Intelent, Princeton, USA
Keywords: Metadata, MDR, automated SAS dataset generation, dynamism, CDISC
Pages: 7 Size: 1785 Kb    Download the presentationdownload (.pdf, 1911 Kb)
tweet!  Efficiency Comes From Reusability and Repeatability
  Hanming Tu, Accenture, Berwyn, USA; Dave Evans, Accenture, Berwyn, USA
Keywords: Data Conversion, ETL, CDISC SDTM, Metadata Standard, Code Reusability, Process Repeatability, Efficiency Level Matrix, Intelligent Data Flow
Pages: 10 Size: 673 Kb    Download the presentationdownload (.pdf, 6355 Kb)
tweet!  Metadata on the go: Achieving metadata accuracy and consistency continually
  Swapna Pothula, SGS Life Sciences, Mechelen, Belgium
Keywords: Metadata, MDRs, CDISC, SDTM, Pinnacle21
Pages: 6 Size: 268 Kb    Download the presentationdownload (.pdf, 1333 Kb)
tweet!  How to effectively deal with hardcoding and CDISC Controlled Terminology in clinical studies
  Lennert van der Zee, OCS Consulting, ‘s-Hertogenbosch, the Netherlands
Keywords: CDISC, clinical
Pages: 10 Size: 545 Kb    Download the presentationdownload (.pdf, 1253 Kb)
tweet!  From SDTM to displays, through ADaM & Analyses Results Metadata, a flight on board METADATA Airlines
  Omar SEFIANI, Boehringer Ingelheim, Reims, France; Stéphane BOUGET, Boehringer Ingelheim, Reims, France
Keywords: DH13 - PhUSE 2016, CDISC
Pages: 10 Size: 390 Kb    Download the presentationdownload (.pdf, 1585 Kb)
tweet!  Clinical Data in Business Intelligence
  Mike Collinson, Oracle Heath Sciences Consulting (HSC), Reading, UK
Keywords: SDTM; Business Intelligence; Oracle; Oracle Health Sciences Consulting; HSC, clinical
Pages: 7 Size: 546 Kb    Download the presentationdownload (.pdf, 1984 Kb)
tweet!  End-to-end data and metadata: It's not only a dream, it’s a reality
  Gérald NEVEU, Danone Nutricia Research, Palaiseau, France
Pages: 6 Size: 332 Kb    Download the presentationdownload (.pdf, 3023 Kb)
tweet!  Developing MDR Metadata Requirements for Operational Implementation
  Andy Richardson, d-Wise, Manchester, UK.; Scott Bahlavooni, d-Wise, Morrisville, NC, USA
Pages: 5 Size: 437 Kb    Download the presentationdownload (.pdf, 241 Kb)
tweet!  Automating ADaM - How to Efficiently Create CDISC ADaM Specifications and Automate their Transformation into Datasets
  H.C. Hart
Keywords: CDISC
Pages: 3 Size: 35 Kb    Download the presentationdownload (.pdf, 266 Kb)
tweet!  The development of standards management using EntimICE-AZ
  Shyamprasad Perisetla, AstraZeneca, Cambridge, UK; Per-Arne Stahl, AstraZeneca, Mölndal, Sweden
Pages: 5 Size: 299 Kb    Download the presentationdownload (.pdf, 1616 Kb)
tweet!  Fast track to Domain: SDTM.PC and SDTM.PP Use Graphic overview of variables to speed up learnings curve.
  Lina Ulkjær Jørgensen, Novo Nordisk A/S, Bagsværd, Denmark
Keywords: CDISC
Pages: 2 Size: 83 Kb    Download the presentationdownload (.pdf, 116 Kb)
tweet!  What is high quality study metadata?
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA, USA; Max Kanevsky, Pinnacle 21, Plymouth Meeting, PA, USA
Pages: 9 Size: 384 Kb    Download the presentationdownload (.pdf, 728 Kb)
tweet!  Japanese Electronic Study Data Submission in CDISC Formats
  Yuichi Nakajima, Novartis Pharma K.K, Tokyo, Japan; Takashi Kitahara, Novartis Pharma K.K, Tokyo, Japan; Ryan Hara, Novartis Pharma AG, Basel, Switzerland
Keywords: PMDA, FDA, CDISC, electronic study data submission, Pinncale 21, legacy data, consultation
Pages: 8 Size: 294 Kb    Download the presentationdownload (.pdf, 1232 Kb)
tweet!  Fast track to define.xml v2.0 – SDTM and ADaM
  Jörn Bilow, Entimo AG, Berlin, Germany
Keywords: define CDISC SDTM ADaM, xml
Pages: 4 Size: 83 Kb    Download the presentationdownload (.pdf, 2621 Kb)
tweet!  Generating Analysis Results and Metadata - report from a PhUSE CS project
  Marc Andersen, StatGroup ApS, Copenhagen, Denmark; Marcelina Hungria, DIcore Group, LLC, NJ, USA; Suhas R. Sanjee, Merck & Co., Inc., Kenilworth, NJ USA
Pages: 10 Size: 1203 Kb    Download the presentationdownload (.pdf, 683 Kb)

Pharmaceutical SAS Users Group China 2016

Best Paper
Practical Experience in Implementing CDISC Standards for Global Cardiovascular, Clinical Outcome Assessment and Respiratory Trials
  David Ju, ERT Inc., Philadelphia, USA
Keywords: CDISC
  Download the slidesdownload (.pdf, 1584 Kb)
tweet!  From Data Collection to Regulatory Submission - a Journey
  Todd Case, Vertex Pharmaceuticals, Boston, USA
Pages: 4 Size: 109 Kb 
tweet!  The Dream of a Common Vision: (Evolving) Standards
  Todd Case, Vertex Pharmaceuticals, Boston, USA
Pages: 4 Size: 93 Kb 
MRCT and Project Centric Approach
  Jingwei Gao, Boehringer Ingelheim, China
  Download the slidesdownload (.pdf, 1535 Kb)
tweet!  ADaM Compliance VS Easy-Reviewed in Design and Construct Efficacy Analysis Datasets
  Huadan Li, MSD R&D (China) Co., Ltd., Beijing, China
Pages: 8 Size: 424 Kb 
tweet!  How to handle the mapping of the eCRF form with the combined information
  Shirley Wu, Roche, Shanghai, CP
Pages: 4 Size: 569 Kb 
Analysis of Patient Reported Outcome (PRO) Endpoints in Clinical Trial
  Tongda Che, MSD R&D China; Peng Wan, MSD R&D China
  Download the slidesdownload (.pdf, 1549 Kb)
Development Approach on the Sponsor-Defined Extensions of the Model
  Gen Pan, Roche, Shanghai, China
  Download the slidesdownload (.pdf, 1223 Kb)
Strategy to Start to Implement CDISC Standards
  Victor Wu, Beijing Data Science Express Consulting Co., Ltd
Keywords: CDISC
  Download the slidesdownload (.pdf, 1173 Kb)
tweet!  Define.xml Content Validation - CRF Page Check
  Shenglin Zhang, PAREXEL
Keywords: xml
Pages: 7 Size: 274 Kb    Download the slidesdownload (.pdf, 892 Kb)
tweet!  ADaM Tips for Exposure Summary
  Kriss Harris, SAS Specialists Limited, Hertfordshire, United Kingdom
Pages: 6 Size: 294 Kb 
tweet!  Building Your Own CDISC Application with SAS® Clinical Standards Toolkit
  Jing Gao, SAS R&D, Beijing, China
Keywords: CDISC
Pages: 13 Size: 792 Kb 
Best Paper
tweet!  Automation of SDTM Programming in Oncology Disease Response Domain
  Yiwen Wang, Eli Lilly and Company, Shanghai, China; Yu Cheng, Eli Lilly and Company, Shanghai, China; Ju Chen, Eli Lilly and Company, Shanghai, China
Keywords: CDISC
Pages: 10 Size: 500 Kb 
tweet!  Proposal for Streamlining the SDRG and ADRG Authoring Process
  Stanley Wei, Reporting System & Tools Group, Beijing Novartis Pharma Co. Ltd., Shanghai
Pages: 1 Size: 1050 Kb 

Western Users of SAS Software 2016

tweet!  You are the Concierge – a CDISC compliant project management tool on SDD
  Chen Shi, Santen Inc.
Keywords: poster presentation, poster design, poster template
Pages: 1 Size: 430 Kb 
tweet!  Are you ready for Dec 17th, 2016 - CDISC compliant data submission?
  Kevin Lee, Clindata Insight
Pages: 6 Size: 251 Kb 
tweet!  Why and What Standards for Oncology Studies (Solid Tumor, Lymphoma and Leukemia)?
  Kevin Lee, Clindata Insight
Pages: 7 Size: 266 Kb 
tweet!  Building Better ADaM Datasets Faster With If-Less Programming
  Lei Zhang, Celgene Corporation
Pages: 17 Size: 710 Kb 
tweet!  SDTM Bookmarking Automation: Leveraging SAS, Ghostscript and Form-Visit Study Data
  Nasser Al Ali, Genentech; Maria Paz, Genentech
Pages: 6 Size: 447 Kb 

Pharmaceutical SAS Users Group 2016

tweet!  Efficient Safety Assessment in Clinical Trials using the Computer-generated AE Narratives of JMP® Clinical
  Richard C. Zink, JMP Life Sciences, SAS Institute, Cary, NC; Drew Foglia, JMP Life Sciences, SAS Institute, Cary, NC
Pages: 13 Size: 445 Kb 
tweet!  The Benefits and Know-how of Building a Central CDISC-Terminology Dictionary with a Macro System
  Solomon Lee, Ph D, South San Francisco, CA; Ronghai Bo, Medicine, WI
Keywords: CDISC, macro
Pages: 4 Size: 30 Kb 
tweet!  Enhanced OpenCDISC Validator Report for Quick Quality Review
  Ajay Gupta, PPD, Morrisville, NC
Keywords: OpenCDISC, SDTM, VBA, EXCEL, Hyperlinks
Pages: 12 Size: 583 Kb 
tweet!  The Power of Perl Regular Expressions: Processing Dataset-XML documents back to SAS® Data Sets
  Joseph Hinson, inVentiv Health, Princeton, NJ
Keywords: Dataset-XML; Perl Regular Expressions; CDISC
Pages: 9 Size: 415 Kb 
tweet!  The Devil is in the Details – Reporting from Pinnacle 21 (OpenCDISC) Validation Report
  Amy Garrett, Novella Clinical, Columbus, OH; Chris Whalen, Clovis Oncology, Boulder, CO
Keywords: CDISC
Pages: 11 Size: 520 Kb 
tweet!  Consider Define.xml Generation during Development of CDISC Dataset Mapping Specifications
  Vara Prasad Sakampally, Vita Data Sciences, Waltham, MA; Bhavin Busa, Vita Data Sciences, Waltham, MA
Keywords: CDISC, xml
Pages: 6 Size: 336 Kb 
tweet!  An Intersection of Pharma and Medical Devices - Development of Companion Diagnostics in Conjunction with Targeted Therapies
  Carey G. Smoak, Portola Pharmaceuticals, South San Francisco, CA
Pages: 4 Size: 335 Kb 
tweet!  The Power of Data Access Functions: An example with Dataset-XML Creation
  Joseph Hinson, inVentiv Health, Princeton, NJ
Keywords: SCL;Data Access Functions; Dataset-XML; XML
Pages: 9 Size: 284 Kb 
tweet!  UTF What? A Guide to Using UTF-8 Encoded Data in a SDTM Submission
  Michael Stackhouse, Chiltern, Cary, NC
Keywords: CDISC
Pages: 10 Size: 423 Kb 
tweet!  Tips and tricks when developing Trial Design Model Specifications that provide Reductions in Creation time
  Ruth Marisol Rivera Barragan, Chiltern International, Inc., Manor, TX
Keywords: TDM, Trial Design Model, Trial Elements, Trial Arms, Trial Summary, Trial Visit, Trial Inclusion, UNII, SNOMED
Pages: 10 Size: 984 Kb 
tweet!  Results-Level Metadata: What, How, and Why
  Frank Dilorio, CodeCrafters, Inc., Philadelphia PA; Jeffrey Abolafia, Rho Inc., Chapel Hill, NC
Keywords: Metadata, Define File, Results Metadata, ARM, end-to-end, define.xml, Metadata repurposing, user interface design
Pages: 11 Size: 322 Kb 
tweet!  Moving up! – SDTM v3.2 – What is new and how to use it
  Alyssa Wittle, Chiltern International, King of Prussia, PA; Christine McNichol, Chiltern International, King of Prussia, PA; Antonio Cardozo, Chiltern International, King of Prussia, PA
Keywords: CDISC SDTM v3.2 IG
Pages: 8 Size: 169 Kb 
tweet!  Getting Started with Data Governance
  Gregory S. Nelson, ThotWave Technologies, Chapel Hill, NC
Pages: 15 Size: 337 Kb 
tweet!  “It is a standard, so it is simple, right?”: Misconceptions and Organizational Challenges of Implementing CDISC at a CRO
  Susan H.M. Boquist, PAREXEL, Billerica, MA; Adam J. Sicard, PAREXEL, Durham, NC
Keywords: CDISC, SDTM, ADaM, SAS
Pages: 5 Size: 290 Kb 
tweet!  Considerations and Conventions within the Therapeutic Area User Guides (TAUGs)
  Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA; Kristin Kelly, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: SDTMIG, Therapeutic Area User Guide
Pages: 8 Size: 52 Kb 
Best Paper
tweet!  Deconstructing ADRS: Tumor Response Analysis Data Set
  Steve Almond, Bayer Inc., Toronto, ON, Canada
Keywords: ADRS;oncology;ADaM;tumor response;RECIST
Pages: 11 Size: 676 Kb 
tweet!  Prepare for Re-entry: Challenges and Solutions for Handling Re-screened Subjects in SDTM
  Charity Quick, Rho, Inc, Chapel Hill, NC; Paul Nguyen, Rho, Inc, Chapel Hill, NC
Keywords: SDTM Re-screened Re-screening Re-enrolled SUBJID USUBJID, CDISC
Pages: 5 Size: 154 Kb 
tweet!  Associated Persons Domains – Who? What? Where? When? Why? How?
  Alyssa Wittle, Chiltern, King of Prussia, PA; Michael Stackhouse, Chiltern, Cary, NC
Pages: 6 Size: 741 Kb 
tweet!  SDTM Trial Summary Domain: Putting Together the TS Puzzle
  Kristin Kelly, Accenture Accelerated R&D Services, Berwyn, PA; Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: SDTM, TS, Trial Summary, CDISC
Pages: 13 Size: 336 Kb 
tweet!  Conformance, Compliance, and Validation: An ADaM Team Lead's Perspective
  John Troxell, Accenture, Berwyn, PA
Keywords: CDISC, ADaM, Conformance, Compliance, Validation
Pages: 7 Size: 242 Kb 
tweet!  Implementation of ADaM Basic Data Structure for Cross-over Studies
  Songhui Zhu, A2Z Scientific Inc., East Brunswick, NJ
Keywords: CDISC; ADaM; BDS; Cross-over
Pages: 10 Size: 413 Kb 
tweet!  TRTP and TRTA in BDS Application per CDISC ADaM Standards
  Maggie Ci Jiang, Teva Pharmaceuticals, West Chester, PA
Keywords: CDISC; ADaM; TRTP; TRTA; ANL01FL; AVISIT; APERIOD
Pages: 8 Size: 668 Kb 
tweet!  Transforming Biomarker Data into an SDTM based Dataset
  Kiran Cherukuri, Seattle Genetics, Inc., Bothell, WA
Keywords: Biomarkers, SDTM, SDTMIG-PGx, CDISC
Pages: 7 Size: 302 Kb 
tweet!  Codelists Here, Versions There, Controlled Terminology Everywhere
  Shelley Dunn, Regulus Therapeutics, San Diego, CA
Keywords: Codelists Versions Controlled Terminology
Pages: 12 Size: 689 Kb 
tweet!  Usage of Pinnacle 21 Community Toolset 2.1.1 for Clinical Programmers
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA; Michael DiGiantomasso, Pinnacle 21, Plymouth Meeting, PA; Travis Collopy, Pinnacle21, Plymouth Meeting, PA
Keywords: Validation, Define.xml, Pinnacle 21 Community, OpenCDISC
Pages: 19 Size: 971 Kb 
tweet!  Good versus Better SDTM: Data Listings
  Mario Widel, Eli Lilly & Co, Indianapolis, IN; Henry Winsor, Relypsa Inc., Redwood City, CA
Keywords: CDISC, SDTM, ICH E3, Listings
Pages: 11 Size: 512 Kb 
tweet!  Moving from Data Collection to Data Visualization and Analytics: Leveraging CDISC SDTM Standards to Support Data Marts
  Steve Kirby, JD, MS, Chiltern, King of Prussia, PA; Terek Peterson, MBA, Chiltern, King of Prussia, PA
Keywords: CDISC
Pages: 8 Size: 853 Kb 
tweet!  The CDISC’s are coming!!
  Annapurna Ravi, inVentiv Health Clinical, Cincinnati, OH; Caroline Gray, inVentiv Health Clinical, Cork, Ireland
Keywords: CDISC
Pages: 7 Size: 71 Kb 
tweet!  A Data Preparation Primer: Getting Your Data Ready for Submission
  Janet Stuelpner, SAS Institute, New Canaan, CT
Keywords: CDISC;submission;quality
Pages: 3 Size: 217 Kb 
tweet!  Creating Time to Event ADaM Dataset for a Complex Efficacy Endpoint in Multiple Sclerosis Therapeutic Area
  Ittai Rambach, Teva Pharmaceuticals LTD., Netanya, Israel
Keywords: CDISC
Pages: 8 Size: 485 Kb 
tweet!  Delivering a quality CDISC compliant accelerated submission using an outsourced model
  Mei Dey, AstraZeneca, Gaithersburg, MD; Diane Peers, AstraZeneca, Alderley Park, Macclesfield, Cheshire, UK
Keywords: CDISC
Pages: 8 Size: 73 Kb 
tweet!  CDISC Standards End-to-End: Transitional Hurdles
  Alyssa Wittle, Chiltern International, King of Prussia, PA; Christine McNichol, Chiltern International, King of Prussia, PA; Antonio Cardozo, Chiltern International, King of Prussia, PA
Keywords: CDISC, SDTM, ADaM, Standards, Training
Pages: 6 Size: 63 Kb 
tweet!  SDTM Metadata: The Output is only as Good as the Input
  Sue Sullivan, d-Wise, Morrisville, NC
Keywords: SDTM, Metadata, CDISC, SHARE, standards, compliance
Pages: 9 Size: 214 Kb 
Best Paper
tweet!  Standards Implementation & Governance: Carrot or Stick?
  Julie Smiley, Akana, San Antonio, TX; Judith Goud, Akana, Bennekom, Netherlands
Pages: 6 Size: 1559 Kb 
tweet!  SDTM Automation with Standard CRF Pages
  Taylor Markway, SCRI Development Innovations, Carrboro, NC
Keywords: CDISC, SDTM, Macro, Automation, Pharmaceutical, SAS Programming
Pages: 10 Size: 338 Kb 
tweet!  Automatic Consistency Checking of Controlled Terminology among SDTM Datasets, Define.xml, and NCI/CDISC Controlled Terminology for FDA Submission
  Min Chen, Alkermes Inc., Waltham, MA; Xiangchen (Bob) Cui, Alkermes Inc., Waltham, MA
Keywords: CDISC, xml
Pages: 13 Size: 725 Kb 
tweet!  Building Efficiency and Quality in SDTM Development Cycle
  Kishore Pothuri, Vita Data Sciences, Waltham, MA; Bhavin Busa, Vita Data Sciences, Waltham, MA
Keywords: CDISC
Pages: 6 Size: 190 Kb 
tweet!  When ANY Function Will Just NOT Do
  Richann Watson, Experis, Batavia, OH; Karl Miller, inVentiv Health, Lincoln, NE
Keywords: SAS Functions ANY NOT CDISC SDTM ADaM
Pages: 8 Size: 92 Kb 
tweet!  A Macro to Automatically Flag Baseline in SDTM
  Taylor Markway, SCRI Development Innovations, Carrboro, NC
Keywords: Pharmaceutical SAS, Macro, Baseline, SDTM, Automation, CDISC
Pages: 8 Size: 250 Kb 
tweet!  Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: SAS CST CDISC Define-XML define.xml metadata ARM ADaM
Pages: 29 Size: 955 Kb    Download the presentationdownload (.pdf, 1961 Kb)
tweet!  Preparing Legacy Format Data for Submission to the FDA - When & Why Must I Do It, What Guidance Should I Follow?
  David C. Izard, Accenture, Berwyn, PA
Keywords: CDISC SDTM CDASH ADaM FDA Guidance Study Data Technical Conformance Guide Standardized Study Data
Pages: 11 Size: 287 Kb 
tweet!  Strategic Considerations for CDISC Implementation
  Amber Randall, Axio Research, Seattle, WA; William Coar, Axio Research, Seattle, WA
Keywords: CDISC, ADaM, SDTM, FDA, PDUFA V, contractors
Pages: 6 Size: 199 Kb 
Best Paper
tweet!  To IDB or Not to IDB: That is the Question
  Kjersten Offenbecker, Spaulding Clinical Research, West Bend, WI; Beth Seremula, Chiltern International, King of Prussia, PA
Pages: 7 Size: 510 Kb 
tweet!  A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM)
  Xiangchen (Bob) Cui, Alkermes, Inc, Waltham, MA; Min Chen, Alkermes, Inc, Waltham, MA
Keywords: CDISC
Pages: 19 Size: 608 Kb 
tweet!  New Features in Define-XML V2.0 and Its Impact on SDTM/ADaM Specifications
  Hang Pang, Vertex Pharmaceuticals Incorporated, Boston, MA
Keywords: CDISC, xml
Pages: 12 Size: 322 Kb 
tweet!  Up-Versioning Existing Define.xml from 1.0 to 2.0
  Jeff Xia, Merck & Co., Rahway, NJ; Lugang Xie (Larry), Merck & Co., Rahway, NJ
Keywords: CDISC, xml
Pages: 7 Size: 499 Kb 
tweet!  A SAS® Macro Tool to Automate Generation of Define.xml V2.0 from SDTM Specification for FDA Submission
  Min Chen, Alkermes Inc., Waltham, MA; Xiangchen (Bob) Cui, Alkermes Inc., Waltham, MA
Keywords: CDISC, macro, xml
Pages: 24 Size: 751 Kb 
tweet!  Achieving Clarity through Proper Study Documentation: An Introduction to the Study Data Reviewer’s Guide (SDRG)
  Michael Stackhouse, Chiltern, Cary, NC; Terek J. Peterson, MBA, Chiltern, King of Prussia, PA
Pages: 5 Size: 530 Kb 
tweet!  What is high quality study metadata?
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA; Max Kanevsky, Pinnacle 21, Plymouth Meeting, PA
Keywords: Study metadata, define.xml, reviewers guide, common issues, FDA
Pages: 9 Size: 383 Kb 
tweet!  Submission-Ready Define.xml Files Using SAS® Clinical Data Integration
  Melissa R. Martinez, SAS Institute, Cary, NC
Keywords: define.xml, define, define file, SAS, CDI, Clinical Data Integration, value level metadata, annotated CRF, supplemental document, yodeling, chickens, annotated case report form, computational algor ...
Pages: 10 Size: 313 Kb 
tweet!  The Standard for the Exchange of Nonclinical Data (SEND): History, Basics, and Comparisons with Clinical Data
  Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Pages: 10 Size: 142 Kb 
Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: CDISC, xml
  Download the Super Demodownload (.pdf, 932 Kb)
Best Paper
tweet!  May the Function Be With You: Helpful SAS® Functions, Particularly When Handling CDISC Data
  Angela Lamb, Chiltern, King of Prussia, PA
Keywords: CDISC
Pages: 9 Size: 341 Kb 
tweet!  Duplicate records - it may be a good time to contact your data management team
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA;Max Kanevsky, Pinnacle 21, Plymouth Meeting, PA
Keywords: Duplicate records, data cleaning, FDA, SAS, Pinnacle 21
Pages: 8 Size: 162 Kb 

Pharmaceutical Users Software Exchange 2015

tweet!  Close operation between Developers and End-Users is Vital to Deployment of CDISC Standard Software
  Donald Benoot, SGS Life Sciences Services
Keywords: CDISC, software implementation, software deployment, usability
Pages: 8 Size: 504 Kb    Download the presentationdownload (.pdf, 269 Kb)
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 Dilorio, 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)
tweet!  Automating Production of the blankcrf.pdf in a CRO Environment
  Jonathan North, S-cubed Biometrics
Keywords: blankcrf.pdf, annotated crf, bookmarks, JavaScript, Adobe Acrobat
Pages: 10 Size: 163 Kb    Download the presentationdownload (.pdf, 482 Kb)
tweet!  Merging Supplemental Data into Parent Domains
  Dirk Van Krunckelsven, Merck
Keywords: #Phuse15
Pages: 5 Size: 231 Kb    Download the presentationdownload (.pdf, 6908 Kb)
tweet!  PhUSE De-identification Working Group: Providing identification Standards to CDISC Data Models
  Jean-Marc Ferran, Qualiance; Khaled El Eman, Privacy Analytics; Sarah Nolan, University of Liverpool
Keywords: CDISC
Pages: 13 Size: 612 Kb    Download the presentationdownload (.pdf, 5044 Kb)
tweet!  Metadata-driven- Yet Another Cliché in our Industry
  Chris Decker, d-Wise; Ian Fleming, d-Wise
Pages: 3 Size: 85 Kb    Download the presentationdownload (.pdf, 3869 Kb)
tweet!  How a Clinical Data Repository can Support Pharmacovigilance
  Pantaleo Nacci, GlaxoSmithKline Vaccines
Keywords: CDISC Pharmacovigilance, clinical
Pages: 7 Size: 98 Kb    Download the presentationdownload (.pdf, 1246 Kb)
tweet!  Finding Out about Findings About
  Carolina Clark-Steel, Sunshine Programming
Keywords: CDISC, SDTM, ADaM, mapping, clinical, events, CE, findings, about, FA
Pages: 2 Size: 231 Kb    Download the posterdownload (.pdf, 765 Kb)
tweet!  EPOCH in Reverse
  Ann Croft, Leo Pharma
Pages: 7 Size: 353 Kb    Download the posterdownload (.pdf, 262 Kb)
tweet!  Standardised Reporting Using ADaM (STREAM Model)
  Ankur Chakraborty, TCS
Pages: 2 Size: 140 Kb    Download the posterdownload (.pdf, 651 Kb)
tweet!  Errors Beyond Open CDISC Validator
  Gayatri Karkera, InVentiv Health Clinical; Ushma KUmar, InVentiv Health Clinical; Neha Mohan, InVentiv Health Clinical
Keywords: CDISC; ADaM; SDTM; Validator; Error; OpenCDISC; Checks; Standard
Pages: 4 Size: 46 Kb    Download the posterdownload (.pdf, 263 Kb)
tweet!  The SAS Clinical Standards Toolkit - A Helpful Tool for Creating CDISC SDTM-compliant Study Data
  Nicolai Haag, HMS Analytical Software
Keywords: CDISC, clinical
Pages: 2 Size: 472 Kb    Download the posterdownload (.pdf, 2858 Kb)
tweet!  Efficient Data Reviews and Quality in Clinical Trials Using CDISC Data Standards
  Valérie Nedbal, SAS Institute
Keywords: CDISC, clinical
Pages: 11 Size: 693 Kb 
tweet!  Implementation of an in-house Data QC Tool to Streamline SDTM Production Data
  Karlien Knevels, SGS Life Sciences Services
Keywords: CDISC
Pages: 3 Size: 73 Kb    Download the presentationdownload (.pdf, 907 Kb)
Understanding Trial Design Using Visualisation
  Maria Benjegard, AstraZeneca R&D; Kerstin Forsberg, AstraZeneca R&D
  Download the presentationdownload (.pdf, 1443 Kb)
tweet!  'Dude. Where's My Graph?' RDF Data Cubes for Clinical Trial Data
  Tim Williams, UCB; Marc Andersen, StatGroup
Keywords: clinical trials results, CDISC, define-xml, force network graph, data visualization, D3js, JSON, Linked Data, metadata, R, RDF, RDF data cube, Resource Description Framework, SAS, semantic web, sum ...
Pages: 7 Size: 702 Kb    Download the presentationdownload (.pptx, 18451 Kb)
tweet!  CDISC Standards and the Semantic Web
  David Iberson-Hurst, Assero
Keywords: CDISC, internet
Pages: 9 Size: 2025 Kb    Download the updated presentationdownload (.pdf, 4627 Kb)

Western Users of SAS Software 2015

tweet!  Building and Customizing a CDISC Compliance and Data Quality Application
  Wayne Zhong, Accretion Softworks
Keywords: CDISC;ADaM;SDTM;compliance;data quality;tool;application
Pages: 5 Size: 349 Kb 

Pharmaceutical SAS Users Group China 2015

Clinical Data Transparency and Sharing: Update on Research Benefits, Risks and the Future
  Matt Becker
tweet!  Summary level clinical site data for data integrity review and inspection planning in NDA and BLA submission
  Jingwei Gao; Nancy Bauer
Pages: 41 Size: 2336 Kb 
tweet!  How to validate clinical data more efficiently with SAS Clinical Standards Toolkit
  Vivian Feng
Pages: 11 Size: 392 Kb 
tweet!  Multilingual data support in Dataset-XML with SAS® Clinical Data Integration
  Jing Gao
Keywords: xml
Pages: 12 Size: 675 Kb 
tweet!  SDTM Electronic Submissions to FDA: Guidelines and Best Practices
  Christina Chang; Kyle Chang
Keywords: CDISC
Pages: 6 Size: 370 Kb 
tweet!  SAS® End-to-End solutions in Clinical Trial
  Emma Liu
Pages: 17 Size: 2280 Kb 
tweet!  Generating Define.xml Using SAS® By Element-by-Element And Domain-by-Domian Mechanism
  Lina Qin
Keywords: Define-XML, define.xml, CRT-DDS, SDTM, CDISC, SAS
Pages: 12 Size: 949 Kb 
tweet!  Tips for efficient CDISC eCRT production
  Lanting Li; Yu Zhu; Yuejuan Meng; Huan Zhu
Keywords: CDISC
Pages: 11 Size: 402 Kb 
tweet!  Automatic generating blankcrf.pdf for Rave Study
  Haiqiang Luo
Keywords: Automatic, blankcrf, Medidata Rave
Pages: 8 Size: 425 Kb 
tweet!  Reading and Resolving OpenCIDSC Message
  Yu Pang
Pages: 23 Size: 1949 Kb 
Best Paper
tweet!  Statistics And Programming In The Globally Evolving Landscape Of Clinical Trial Registration And Results (CTRR) Disclosure
  Paul Ngai; Joyce Hauze
Pages: 8 Size: 197 Kb 
tweet!  Generic Macros for Data Mapping
  Qian Zhao; John Wang; Ruofei Hao
Keywords: macro
Pages: 9 Size: 620 Kb 
tweet!  Approaches to Missing Data in the Analysis of SpondyloArthritis International Society (ASAS 20) Response and the Creation of the Related CDISC Compliant Analysis Datasets
  Christine Joy Dureza
Keywords: CDISC
Pages: 12 Size: 847 Kb 
tweet!  SAS® Tools for Working with Dataset-XML files
  Lex Jansen
Keywords: SAS CST CDISC Dataset-XML Define-XML define.xml metadata
Pages: 18 Size: 563 Kb 
tweet!  Hands-On ADaM ADAE Development
  Sandra Minjoe
Pages: 7 Size: 60 Kb 
tweet!  A Macro to Add Variables to SDTM Standard Domains
  Xianhua Zeng
Keywords: CDISC, macro
Pages: 5 Size: 357 Kb 

Pharmaceutical SAS Users Group 2015

tweet!  Accelerate define.xml generation using defineReady
  Senthilkumar Karuppiah, Navitas LLP, Chennai, India; Georgina Wood, Navitas LLP, Princeton, New Jersey, USA
Keywords: define.xml, CDISC
Pages: 4 Size: 301 Kb 
Best Paper
tweet!  Have SAS Annotate your Blank CRF for you! Plus dynamically add color and style to your annotations
  Steven Black, Agility-Clinical Inc., Carlsbad, CA
Keywords: Blank CRF, Annotate, Adobe, FDF, SAS
Pages: 12 Size: 351 Kb 
tweet!  A SAS® Macro Tool to Automate Generation of Define.xml V2.0 from ADaM Specification for FDA Submission
  Min Chen, Alkermes Inc., Waltham, MA; Xiangchen (Bob) Cui, Alkermes Inc., Waltham, MA
Keywords: CDISC, macro, xml
Pages: 28 Size: 910 Kb 
tweet!  SDTM Annotations: Automation by implementing a standard process
  Geo Joy, Novartis, Cambridge, MA; Andre Couturier, Novartis, East Hanover, NJ
Keywords: CDISC
Pages: 11 Size: 946 Kb 
tweet!  A Toolkit to Create a Dynamic Excel Format Metadata to Assist SDTM Mapping Process
  Huei-Ling Chen, HLC Analytics Inc., Edison, NJ; Helen Wang, Sanofi, Bridgewater, NJ
Keywords: CDISC
Pages: 11 Size: 673 Kb 
tweet!  Process and Programming Challenges in Producing Define.xml
  Mike Molter, d-Wise, Morrisville, NC
Keywords: CDISC, xml
Pages: 13 Size: 286 Kb 
tweet!  A Unique Way to Annotate Case Report Forms (CRFs) in PDF, Using Forms Data Format (FDF) Techniques
  Boxun Zhang, Seattle Genetics Inc., Bothell, WA; Tyler Kelly, Seattle Genetics Inc., Bothell, WA
Keywords: SAS, CRFs, aCRFs, Annotation, FDF, PDF, SAS COMPGED
Pages: 6 Size: 472 Kb 
tweet!  Fresh Cup of Joe: Utilizing Java to automate Define.XML for SDTM Origin mapping from SAS® aCRF PDFs
  Tony Cardozo, Theorem Clinical Research, King of Prussia, PA
Keywords: SAS Annotations Java Automation, CDISC, xml
Pages: 9 Size: 187 Kb 
Clinical Trials Analysis Driven by CDISC Data Standards
  Kelci Miclaus, JMP
Keywords: CDISC
tweet!  Understanding SE, TA, TE Domains
  Jacques Lanoue, Novartis Pharmaceuticals Corporation, East Hanover, NJ
Pages: 4 Size: 128 Kb 
tweet!  SDTM TE, TA, and SE Domains: Demystifying the Development of SE
  Kristin Kelly, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA; Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: CDISC
Pages: 6 Size: 271 Kb 
tweet!  Considerations in Conforming Data from Multiple Implantable Medical Devices to CDISC Standards Using SAS®
  Julia Yang, Medtronic plc., Mounds View, MN
Keywords: CDISC
Pages: 9 Size: 184 Kb 
tweet!  ADDL Model for Device Analysis
  Priya Gopal, Theorem Clinical, King of Prussia, PA
Keywords: 'Device Analysis' 'ADDL' ' Metadata'
Pages: 6 Size: 302 Kb 
tweet!  LOCF vs. LOV in Endpoint DTYPE Development with CDISC ADaM Standards
  Maggie Ci Jiang, Teva Pharmaceuticals, West Chester, PA
Keywords: CDISC
Pages: 6 Size: 93 Kb 
tweet!  Considerations in ADaM Occurrence Data: Handling Crossover Records for Non-Typical Analysis
  Karl Miller, inVentiv Health, Lincoln, NE; Richann Watson, Experis, Batavia, OH
Keywords: ADaM, OCCDS, ANLzzFL, CDISC
Pages: 6 Size: 241 Kb 
Best Paper
tweet!  The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future
  Shelley Dunn, d-Wise, Morrisville, NC; Ed Lombardi, Agility Clinical, Carlsbad, CA
Keywords: CDISC
Pages: 9 Size: 521 Kb 
tweet!  Proper Parenting: A Guide in Using ADaM Flag/Criterion Variables and When to Create a Child Dataset
  Richann Watson, Experis, Batavia, OH; Karl Miller, inVentiv Health, Lincoln, NE; Paul Slagle, inVentiv Health, Ann Arbor, MI
Keywords: ADaM, BDS, ANLzzFL, CRITy, CRITyFL, AVALCATy, CDISC
Pages: 10 Size: 411 Kb 
tweet!  ADaM Example for a Complex Efficacy Analysis Dataset
  Milan Mangeshkar, Exelixis, Inc., South San Francisco, CA; Sandra Minjoe, Accenture Life Sciences, San Francisco, CA
Keywords: ADaM, efficacy, interim, intermediate, fundamental principles, traceability, BDS, data review, analysis-ready, flexible, CDISC
Pages: 8 Size: 495 Kb 
tweet!  PhUSE De-Identification Working Group: Providing De-Identification Standards to CDISC Data Models
  Jean-Marc Ferran, Qualiance & PhUSE, Copenhagen, Denmark; Jacques Lanoue, Novartis, East Hanover, NJ
Keywords: CDISC
Pages: 8 Size: 407 Kb 
tweet!  It Depends On Your Analysis Need
  Sandra Minjoe, Accenture Life Sciences, San Francisco, CA
Keywords: ADaM, fundamental principles, BDS, ADSL, ADAE, CSS, ADRG, FDA, Technical Conformance Guide, parameters, baseline characteristics, parameter metadata, results metadata
Pages: 10 Size: 392 Kb 
tweet!  DIABETES: Submission Data Standards and Therapeutic End Points
  Naveed M Khaja, SW-T Consulting Group Inc., West Chester, PA
Pages: 9 Size: 369 Kb 
tweet!  Implementing Various Baselines for ADaM BDS datasets
  Songhui Zhu, A2Z Scientific Inc., East Brunswick, NJ
Keywords: CDISC
Pages: 7 Size: 173 Kb 
tweet!  What to Expect in SDTMIG v3.3
  Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: CDISC
Pages: 10 Size: 220 Kb 
tweet!  Considerations in Submitting Non-Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain
  Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA; Richard Lewis, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: SDTM, Supplemental Qualifiers, Findings About, Interventions, Events
Pages: 6 Size: 62 Kb 
tweet!  What is the “ADAM OTHER” Class of Datasets, and When Should it be Used?
  John Troxell, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: CDISC
Pages: 5 Size: 327 Kb 
ADaM Implementation Roundtable Discussion
  Nancy Brucken, inVentiv Health Clinical; Richann Watson, Experis; Steve Kirby, Theorem Clinical Research
Keywords: CDISC
tweet!  Managing Custom Data Standards in SAS® Clinical Data Integration
  Melissa R. Martinez, SAS
Keywords: SAS, CDI, SSD, Drug Development, CDISC, Data Standards, Clinical Data Integration
Pages: 17 Size: 374 Kb 
tweet!  Usage of OpenCDISC Community Toolset 2.0 for Clinical Programmers
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA; Michael DiGiantomasso, Pinnacle 21, Plymouth Meeting, PA; Travis Collopy, Pinnacle21, Plymouth Meeting, PA
Keywords: OpenCDISC, Validator, Define.xml, Data Converter, ClinicalTrials.gov, Toolset
Pages: 19 Size: 1765 Kb 
tweet!  Tackling Clinical Lab Data in Medical Device Environment
  Juan Wu, Medtronic plc., Santa Rosa, CA; Min Lai, Medtronic plc., Santa Rosa, CA
Keywords: Laboratory results, Lab test library, Lab unit conversion library, SDTM, LB
Pages: 7 Size: 367 Kb 
tweet!  Two different use cases to obtain best responses using RECIST 1.1: SDTM and ADaM
  Kevin Lee, Accenture Life Sciences, Berwyn, PA; Vikash Jain, Inventiv Health Clinical, Princeton, NJ
Keywords: CDISC
Pages: 17 Size: 404 Kb 
tweet!  Tips on Creating a Strategy for a CDISC Submission
  Rajkumar Sharma, Nektar Therapeutics, San Francisco, CA
Keywords: CDISC
Pages: 5 Size: 101 Kb 
tweet!  Summing up - SDTM Trial Summary Domain
  Yi Liu, Celerion Inc., Lincoln, NE; Jenny Erskine, Celerion Inc., Belfast, Northern Ireland; Stephen Read, Celerion Inc., Belfast, Northern Ireland
Keywords: CDISC
Pages: 9 Size: 699 Kb 
tweet!  Leveraging ADaM Principles to Make Analysis Database and Table Programming More Efficient
  Andrew L Hulme, PPD, Kansas City, MO
Keywords: CDISC, ADaM, BDS, TLF, ADaM implementation, analysis database, tables
Pages: 13 Size: 452 Kb 
tweet!  Subset without Upsets: Concepts and Techniques to Subset SDTM Data
  Jhelum Naik, PPD, Wilmington, NC; Sajeet Pavate, PPD, Wilmington, NC
Keywords: SDTM; Subset; Cut; Calendar date; Visit; Concepts to subset; Techniques to subset; interim cut, CDISC
Pages: 6 Size: 153 Kb 
tweet!  Evaluating SDTM SUPP Domain For AdaM - Trash Can Or Buried Treasure
  Xiaopeng Li, Celerion, Lincoln, NE; Yi Liu, Celerion, Lincoln, NE; Chun Feng, Celerion, Lincoln, NE
Keywords: SDTM, ADaM, SDTM SUPP domain, analysis, CDISC
Pages: 7 Size: 401 Kb 
tweet!  Challenges in Developing ADSL with Baseline Data
  Hongyu Liu, Vertex Pharmaceuticals Incorporated, Boston, MA; Hang Pang, Vertex Pharmaceuticals Incorporated, Boston, MA
Pages: 6 Size: 225 Kb 
tweet!  Introducing a Similarity Statistic to Compare Data Libraries for Improving Program Efficiency for Similar Clinical Trials
  Taylor Markway, PRA Health Sciences, Raleigh, NC; Amanda Johnson, PRA Health Sciences, Raleigh, NC
Keywords: SAS, Clincal Trials, Study Similarity, CDISC, SDTM, Automation
Pages: 5 Size: 77 Kb 
tweet!  EXTENDED ATTRIBUTES: A New Metadata Creation Feature in SAS® 9.4 for Data Sets and Variables
  Joseph Hinson, inVentiv Health, Princeton, NJ, USA
Keywords: EXTENDED ATTRIBUTES; METADATA; CDISC; DEFINE-XML
Pages: 8 Size: 181 Kb 
Supporting Dataset-XML with the SAS© Clinical Standards Toolkit
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: CDISC, xml
  Download the Super Demodownload (.pdf, 886 Kb)
Creating Define-XML Version 2 with the SAS® Clinical Standards Toolkit
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: CDISC, xml
  Download the Super Demodownload (.pdf, 1122 Kb)
tweet!  Getting Loopy with SAS® DICTIONARY Tables: Using Metadata from DICTIONARY Tables to Fulfill Submission Requirements
  Jeanina Worden, Santen Inc., Emeryville, CA
Keywords: DICTIONARY tables; PROC SQL; CALL EXECUTE; Submission standards; SDTM; FDA
Pages: 8 Size: 82 Kb 
Best Paper
tweet!  Japanese submission/approval processes from programming perspective
  Ryan Hara, Novartis Pharma AG, Basel, Switzerland
Keywords: Japanese Submission
Pages: 7 Size: 239 Kb 
tweet!  Begin with the End in Mind – Using FDA Guidance Documents as Guideposts when Planning, Delivering and Archiving Clinical Trials
  David C. Izard, Accenture, Berwyn, PA
Keywords: FDA Guidance Standardized Study Data Technical Conformance Guide CDISC SDTM SEND ADaM Regulatory Submission SDS TCG eCTD
Pages: 12 Size: 281 Kb 
tweet!  OSI Packages: What you need to know for your next NDA or BLA Submission
  Thaddea Dreyer, AstraZeneca, Gaithersburg, MD; Tatiana Scetinina, AstraZeneca, Gaithersburg, MD
Keywords: OSI BIMO Inspections FDA Site clinsite.xpt 'Part I' 'Part II' 'Part III'
Pages: 10 Size: 589 Kb 
tweet!  The Most Common Issues in Submission Data
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA; Max Kanevsky, Pinnacle 21, Plymouth Meeting, PA
Pages: 9 Size: 303 Kb 
tweet!  Getting Rid of Bloated Data in FDA Submissions
  Ben Bocchicchio, SAS Institute, Cary, NC; Frank Roediger, SAS Institute, Cary, NC
Keywords: SAS Drug Development;SDD;FDA;Conformance Guide;Rules;OpenCDISC
Pages: 8 Size: 519 Kb 
tweet!  SAS® Tools for Working with Dataset-XML files
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: SAS CST CDISC Dataset-XML Define-XML define.xml metadata
Pages: 18 Size: 575 Kb    Download the presentationdownload (.pdf, 1690 Kb)
tweet!  Using SAS® Clinical Data Integration to Roundtrip a Complete Study Study Metadata (Define-XML) and Study Data (Dataset-XML)
  Ken Ellis, SAS Institute Inc., Cary, NC
Keywords: Define-XML Dataset-XML
Pages: 19 Size: 939 Kb 

SouthEast SAS Users Group 2014

tweet!  SDTM What? ADaM Who? A Programmer's Introduction to CDISC
  Venita DePuy
Pages: 9 Size: 410 Kb 
tweet!  Stretching Data Training Methods: A Case Study in Expanding SDTM Skills
  Richard Addy
Keywords: ods
Pages: 4 Size: 40 Kb 

Pharmaceutical Users Software Exchange 2014

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)
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)
tweet!  Automating Production of the Blankcrf.pdf
  Joseph Rowley, Novartis; Walter Hufford, Novartis
Pages: 5 Size: 287 Kb    Download the presentationdownload (.pdf, 1446 Kb)
Leveraging R And Shiny for Point and Click ADaM Analysis
  Ian Fleming, s-Wise
  Download the presentationdownload (.pdf, 1497 Kb)
tweet!  ADaM Conversions: The Good, The Bad and The Ugly
  Carla Santillan, Business & Decision Life Sciences; Jessica Minuke, Business & Decision Life Sciences
Pages: 11 Size: 780 Kb    Download the presentationdownload (.pdf, 6336 Kb)
tweet!  SDTM in Business Intelligence
  Mike Collinson, Oracle Health Sciences Consulting
Keywords: CDISC
Pages: 3 Size: 150 Kb    Download the presentationdownload (.pdf, 1529 Kb)
tweet!  From ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials
  Alexandre Mathis, Actelion Pharmaceuticals
Keywords: CDISC, clinical
Pages: 5 Size: 445 Kb    Download the posterdownload (.pdf, 2031 Kb)
Best Presentation
tweet!  Implementation of Oncology Specific SDTM Domains
  Jacintha Eben, SGS
Keywords: CDISC
Pages: 8 Size: 3288 Kb    Download the posterdownload (.pdf, 574 Kb)
tweet!  The PhUSE Therapeutic Area Wiki Page
  Jothy Kalathiparampil, UCB BioSciences; Oliver Wirtz, UCB BioSciences
Pages: 2 Size: 39 Kb    Download the posterdownload (.pdf, 652 Kb)
tweet!  Representation of Foundation CDISC Standards Using RDF
  Geoff Low, Medidata Solutions; Frederik Malfait, IMOS Consulting; Scott Bahlavooni, Biogen Idec
Keywords: CDISC
Pages: 3 Size: 156 Kb    Download the posterdownload (.pdf, 783 Kb)
tweet!  Migrating Between SAS Clinical Standards Toolkit - Versions 1.5 and 1.6. Is that an African or a European Swallow?
  Gene Lightfoot, SAS Institute
Keywords: clinical
Pages: 6 Size: 506 Kb    Download the posterdownload (.pdf, 233 Kb)
tweet!  SDTM Mapping Becomes more EASY with SAS Clinical Data Integration
  Saumilkumar Tripathi, Cytel
Keywords: CDISC, clinical
Pages: 8 Size: 723 Kb    Download the posterdownload (.pdf, 1725 Kb)
Collaborative Development of an Open Source Repository for Standardised Analysis Using Cloud Services
  Michael Carniello, Astellas; Hanming Tu, Accenture; Dirk Spruck, Accovion
  Download the posterdownload (.pdf, 782 Kb)
tweet!  Creating Standard Analyses and Displays for Common Safety Assessments in Clinical Study Reports
  Mary Nilsson, Eli Lilly & Company; Ann Croft, Leo Pharma; Dirk Spruck, Accovion
Keywords: clinical
Pages: 3 Size: 91 Kb    Download the posterdownload (.pdf, 1358 Kb)
tweet!  Signal Detection of Misconduct in Clinical Trials
  Geoffrey Mann, SAS Institute JMP Division
Keywords: clinical
Pages: 7 Size: 632 Kb    Download the presentationdownload (.pdf, 766 Kb)
tweet!  FDA Guidance on Standardised Study Data for Electronics Submissions
  Lauren Shinaberry, Business & Decision Life Sciences; Éanna Kiely, Business & Decision Life Sciences
Pages: 7 Size: 449 Kb    Download the presentationdownload (.pdf, 4608 Kb)
tweet!  Traceability: Plan Ahead for Future Needs
  Sandra Minjoe, Accenture
Pages: 8 Size: 338 Kb    Download the presentationdownload (.pdf, 1219 Kb)
tweet!  Update on Regulatory Guidance: Data Standardisation Planning for Clinical Development Programs
  James Johnson, Summit Analytical
Keywords: clinical
Pages: 10 Size: 494 Kb    Download the presentationdownload (.pdf, 1545 Kb)
tweet!  Automated SDTM Creation and Discrepancy Detection Jobs: The Numbers Tell the Tale
  Joris De Bondt, SGS Life Science Services
Keywords: CDSIC SDTM, CDISC
Pages: 2 Size: 147 Kb    Download the presentationdownload (.pdf, 2139 Kb)
tweet!  Why Don't You Define It?
  Nick De Donder, Business & Decision Life Sciences; Anne-Sophie Bekx, Business & Decision Life Sciences
Pages: 7 Size: 241 Kb    Download the presentationdownload (.pdf, 3839 Kb)
tweet!  Running OpenCDISC from SAS
  Mark Crangle, ICON
Keywords: CDISC OpenCDISC
Pages: 10 Size: 222 Kb    Download the presentationdownload (.pdf, 990 Kb)
tweet!  SANOFI Clinical Data Integration Solution as Part of SDTM Creation
  Nadine Mourin, Sanofi; Hasnaa Likaoui, Keyrus; Melissa Martinez, SAS Institute
Keywords: CDISC, clinical
Pages: 9 Size: 426 Kb    Download the presentationdownload (.pdf, 2573 Kb)
tweet!  Managing Custom Data Standards in SAS® Clinical Data Integration
  Melissa Martinez, SAS Institute
Keywords: clinical
Pages: 12 Size: 307 Kb    Download the presentationdownload (.pdf, 5858 Kb)
tweet!  A Day in the Life of an RDF Curator
  Josephine Anne Gough, Roche
Pages: 4 Size: 91 Kb    Download the presentationdownload (.pdf, 5021 Kb)
tweet!  A Primer on Converting Analysis Results Data to RDF Data Cubes using Free and Open Source Tools
  Tim Williams, UCB BioSciences
Keywords: ADaM, Analysis Results, ARQ,Data Cube, Linked Data, Metadata, OpenRefine, Open Source, Publisci, RDF, Ruby, Semantic Web, SPARQL
Pages: 9 Size: 227 Kb    Download the presentationdownload (.pdf, 6399 Kb)

Pharmaceutical SAS Users Group China 2014

tweet!  Brief Introduction of Oncology Domains in SDTMIG,Version 3.2
  Haishan Kadeerbai
Keywords: CDISC
Pages: 3 Size: 260 Kb 
tweet!  Design and Construct Efficacy Analysis Datasets in Later Phase Oncology Study
  Huadan Li
Pages: 9 Size: 454 Kb 
tweet!  An implementation of XSL-FO techniques to convert define.pdf from define.xml
  Kyle Chang
Keywords: PharmaSUG, xml
Pages: 6 Size: 400 Kb 
Best Paper
Hoping to do an FDA submission with CDISC compliant? Join me for a Mock Drill !!!
  Vijayalakshmi Gajulapalli
Keywords: CDISC
Easy ADaM implementation: Case Study
  Victor Wu
Implementation in the CDSIC Tumor Domains
  Junjie Shang
Automating Production of the blankcrf.pdf
  Walter Hufford
How to meet one new FDA requirement - OSI (Office of Scientific Investigation)
  Xuebo Pi
tweet!  Submission of Pharmacokinetics (PK) Data in a CDISC Compliant Format
  Yu Zhu
Keywords: CDISC
Pages: 9 Size: 343 Kb 
tweet!  Data Transparency and Sharing: Research Benefits, Risks and the Future
  Matthew Becker
Pages: 3 Size: 205 Kb 

Western Users of SAS Software 2014

tweet!  Exploring Phase 1 ADaM Deriving System from SDTM
  Yiwen Li, Gilead Sciences
Pages: 4 Size: 122 Kb 

Pharmaceutical SAS Users Group 2014

tweet!  Creating Define.xml v2 Using SAS® for FDA Submissions
  Qinghua (Kathy) Chen, Exelixis, Inc. South San Francisco, CA; James Lenihan, Exelixis, Inc. South San Francisco, CA
Keywords: Define.XML, SAS, FDA Submissions, CDISC
Pages: 20 Size: 481 Kb 
tweet!  DefKit : A Micro Framework for CDISC Define-XML Application Development
  Lei Zhang, Celgene Corp., Summit, NJ
Keywords: DefKit Micro Framework, CDISC, Define-XML, Hash Object, %XCAT, %XOUT, Template, PERL Regular Expression
Pages: 23 Size: 179 Kb 
Best Paper
tweet!  Let SAS© Improve Your CDISC Data Quality
  Wayne Zhong, Accenture, Berwyn, PA
Keywords: data quality; CDISC; data driven; macros
Pages: 12 Size: 501 Kb 
tweet!  The New Tradition: SAS® Clinical Data Integration
  Vincent J. Amoruccio, Alexion Pharmaceuticals, Inc., Cheshire, CT; Janet Stuelpner, SAS, Cary, NC
Keywords: BASE SAS, Clinical Data Integration, Metadata
Pages: 18 Size: 552 Kb 
tweet!  D is for Dynamic, putting Dynamic back into CDISC (A simple macro utilizing PROC SQL which auto-formats continuous variables for lab tables)
  Steven Black, SynteractHCR, Carlsbad, CA
Keywords: PROC SQL, MACO Language, SAS, functions, CDISC, Paramn, AVAL, macro
Pages: 9 Size: 81 Kb 
tweet!  An Alternative Way to Detect Invalid Reference Records in Supplemental Domains
  Steven Wang, inVentiv Health Clinical, Indianapolis, IN
Pages: 5 Size: 30 Kb 
tweet!  A Toolkit to Check Dictionary Terms in SDTM
  Huei-Ling Chen, Tech Data Services, Bridgewater, NJ; Helen Wang, Sanofi, Bridgewater, NJ
Keywords: CDISC
Pages: 8 Size: 72 Kb 
tweet!  BreakOnWord: A Macro for Partitioning Long Text Strings at Natural Breaks
  Richard Addy, Rho, Chapel Hill, NC; Charity Quick, Rho, Chapel Hill, NC
Keywords: SAS, SDTM, macro, text string, partition
Pages: 8 Size: 50 Kb 
tweet!  Automating Production of the blankcrf.pdf
  Walter Hufford, Novartis, East Hanover, NJ
Keywords: blankcrf, automate, FDF
Pages: 5 Size: 289 Kb 
tweet!  Reducing Variable Lengths for Submission Dataset Size Reduction
  Sandra VanPelt Nguyen, inVentiv Health Clinical
Keywords: CDISC, FDA, dataset, size
Pages: 6 Size: 186 Kb 
tweet!  Discover Define-XML
  Mark Wheeldon, Formedix, Burlington, MA; Kevin Burges, Formedix, Burlington, MA
Keywords: xml
Pages: 12 Size: 1411 Kb 
tweet!  Forging New SDTM Standards for In-Vitro Diagnostic (IVD) Devices: A Use-Case
  Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA; Smitha Krishnamurthy, Roche Molecular Systems, Inc., Pleasanton, CA; Mansi Singh, Roche Molecular Systems, Inc., Pleasanton, CA; Sy Truong, Meta-Xceed, Inc., Fremont, CA
Keywords: CDISC
Pages: 6 Size: 148 Kb 
tweet!  Considerations in Creating SDTM Trial Design Datasets
  Jerry Salyers, Accenture Life Sciences, Berwyn, PA; Richard Lewis, Accenture Life Sciences, Berwyn, PA; Kim Minkalis, Accenture Life Sciences, Berwyn, PA; Fred Wood, Accenture Life Sciences, Berwyn, PA
Keywords: SDTM, Trial Design Model, Datasets, CDISC
Pages: 9 Size: 159 Kb 
tweet!  Considerations in the Submission of Exposure Data in SDTM-Based Datasets
  Fred Wood, Accenture Life Sciences, Wayne, PA; Jerry Salyers, Accenture Life Sciences, Wayne, PA; Richard Lewis, Accenture Life Sciences, Wayne, PA; Kristin Kelly, Accenture Life Sciences, Wayne, PA
Keywords: CDISC
Pages: 6 Size: 48 Kb 
tweet!  Data Standards Development for Therapeutic Areas: A Focus on SDTM-Based Datasets
  Fred Wood, Accenture Life Sciences, Wayne, PA; Diane Wold, Glaxo SmithKline, Research Triangle Park, NC; Rhonda Facile, CDISC, Austin, TX; Wayne Kubick, CDISC
Keywords: CDISC
Pages: 10 Size: 235 Kb 
tweet!  Referencing Medical Device Data in Standard SDTM domains
  Timothy L Bullock, Allergan, Santa Barbara, CA; Ramkumar Krishnamurthy, Allergan, Santa Barbara, CA
Keywords: SDTM Device FA Findings About Procedure, CDISC
Pages: 7 Size: 497 Kb 
tweet!  Applying ADaM BDS Standards to Therapeutic Area Ophthalmology
  Songhui Zhu, A2Z Scientific Inc., East Brunswick, NJ
Keywords: CDISC
Pages: 10 Size: 227 Kb 
tweet!  Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS
  Karin LaPann, PRA International, Horsham, PA; Terek Peterson, MBA, PRA International, Horsham, PA
Keywords: Questionnaire ADQS QS ADaM SDTM CDISC Conversions
Pages: 20 Size: 795 Kb 
tweet!  An ADaM Interim Dataset for Time-to-Event Analysis Needs
  Tom Santopoli, Accenture, Berwyn, PA; Kim Minkalis, Accenture, Berwyn, PA; Sandra Minjoe, Accenture, Berwyn, PA
Keywords: CDISC
Pages: 9 Size: 85 Kb 
tweet!  Developing ADaM Specifications to Embrace Define-XML 2.0.0 Requirements
  Lin Yan, Celgene Corporation, 300 Connell Drive, Berkeley Heights, NJ
Keywords: CDISC, xml
Pages: 10 Size: 366 Kb 
tweet!  A Guide to the ADaM Basic Data Structure for Dataset Designers
  Michelle Barrick, Eli Lilly and Company, Indianapolis, IN; John Troxell, John Troxell Consulting LLC, Bridgewater, NJ
Keywords: CDISC, ADaM, BDS
Pages: 12 Size: 311 Kb 
tweet!  Effective Use of Metadata in Analysis Reporting
  Jeffrey Abolafia, Rho Inc., Chapel Hill, NC
Keywords: Metadata, Define File, Results
Pages: 9 Size: 393 Kb 
Best Paper
tweet!  How Valued is Value Level Metadata?
  Shelley Dunn, d-Wise, Morrisville, NC
Pages: 12 Size: 408 Kb 
Best Paper
tweet!  CDISC Electronic Submission
  Kevin Lee, Accenture Life Sciences, Berwyn, PA
Keywords: CDISC
Pages: 6 Size: 270 Kb 
tweet!  A Road Map to Successful CDISC ADaM Submission to FDA: Guidelines, Best Practices & Case Studies
  Vikash Jain, Accenture Life Sciences, Berwyn, PA; Sandra Minjoe, Accenture Life Sciences, Berwyn, PA
Keywords: CDISC
Pages: 9 Size: 587 Kb 
tweet!  OpenCDISC Validator Implementation: A Complex Multiple Stakeholder Process
  Terek Peterson, MBA, PRA International, Horsham, PA; Gareth Adams, PRA International, Swansea, United Kingdom
Keywords: CDISC
Pages: 9 Size: 285 Kb 
tweet!  Update: Development of White Papers and Standard Scripts for Analysis and Programming
  Nancy Brucken, inVentiv Health Clinical, Ann Arbor, MI; Michael Carniello, Takeda Development Center Americas, Inc., Deerfield, IL; Mary Nilsson, Eli Lilly and Company, Indianapolis, IN; Hanming Tu, Accenture, Wayne, PA
Keywords: CSS, Working Group, standard scripts
Pages: 3 Size: 34 Kb 
tweet!  An Alternative Way to Create Define.XML for ADaM with SAS Macro Automation
  Yiwen Li, Gilead Sciences, Foster City, CA
Keywords: CDISC, macro, xml
Pages: 4 Size: 51 Kb 
tweet!  SAS® as a Tool to Manage Growing SDTM+ Repository for Medical Device Studies
  Julia Yang, Medtronic Inc. Mounds View, MN
Keywords: CDISC
Pages: 12 Size: 715 Kb 
A How-To Guide for Extending Controlled Terminology Using SAS Clinical Data Integration
  Melissa Martinez, SAS Institute, Cary, NC
tweet!  Round Trip Ticket – Using the Define.xml file to Send and Receive your Study Specifications
  Julie Maddox, SAS Institute Inc., Cary, NC
Keywords: CRT-DDS,DEFINE.XML, SAS Clinical Data Integration, SAS Clinical Standards Toolkit, SAS Clinical Data Integration, CDISC
Pages: 10 Size: 399 Kb    Download the Super Demodownload (.pdf, 1061 Kb)
An Integrated platform to manage Clinical data, Metadata and Data Standards
  Romain Rutten, Janssen Research and Development; Peter Wang, Janssen Research and Development; Sharon Trevoy, SAS Institute, Cary, NC
tweet!  Creating Define-XML version 2 with the SAS® Clinical Standards Toolkit 1.6
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: SAS CST CDISC CRT-DDS Define-XML define.xml metadata
Pages: 33 Size: 1331 Kb    Download the presentationdownload (.pdf, 1404 Kb)
tweet!  Hands-On ADaM ADAE Development
  Sandra Minjoe, Accenture Life Sciences, Wayne, PA; Kim Minkalis, Accenture Life Sciences, Wayne, PA
Keywords: ADaM, ADAE, adverse event, CDISC
Pages: 7 Size: 207 Kb 
tweet!  SDTM, ADaM and define.xml with OpenCDISC®
  Angela Ringelberg, Ockham Onocology, Cary, NC; Tracy Sherman, inVentiv Health Clinical, Cary, NC
Keywords: CDISC, xml
Pages: 21 Size: 1809 Kb 
Best Paper
tweet!  Challenges in Processing Clinical Lab Data
  Alan Meier, MedImmune, LLC, Gaithersburg, MD
Pages: 15 Size: 651 Kb 
tweet!  Common Variables in Adverse Event and Exposure analysis datasets specific for Oncology clinical trials
  Haridasan Namboodiri, PRA International, Horsham, PA
Pages: 11 Size: 222 Kb 
tweet!  Good versus Better SDTM – Why “Good Enough” May No Longer Be Good Enough When It Comes to SDTM
  Henry Winsor, Relypsa, Inc., Redwood City, CA
Keywords: CDISC
Pages: 6 Size: 201 Kb 
tweet!  CDISC Mapping and Supplemental Qualifiers
  Arun Raj Vidhyadharan, inVentiv Health, Somerset, NJ; Sunil Mohan Jairath, inVentiv Health, Somerset, NJ
Keywords: Abstract, CDISC
Pages: 6 Size: 365 Kb 
Best Paper
tweet!  Adopted Changes for SDTMIG v3.1.3 and 2013 OpenCDISC Upgrades
  Yi Liu, Celerion Inc., Lincoln, NE; Stephen Read, Celerion Inc., Belfast, Northern Ireland, UK
Keywords: CDISC
Pages: 17 Size: 636 Kb 
tweet!  Route to SDTM Implementation in In-Vitro Diagnostic Industry: Simple or Twisted
  Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA; Sofia Shamas, MaxisIT Inc., NJ; Chowdagam Chaitanya, MaxisIT Inc., NJ; Don Lim, Bluewave Consulting Inc., CA; Girish Rajeev, InVentiv Health Clinical, FL
Keywords: CDISC
Pages: 10 Size: 646 Kb 
tweet!  Automation of ADAM Dataset Creation with a Retrospective, Prospective and Pragmatic Process
  Karin LaPann, MSIS, PRA International, Horsham, PA; Terek Peterson, MBA, PRA International, Horsham, PA
Keywords: ADaM, CDASH, ODM, Standards, Mapping Tool, CDISC
Pages: 6 Size: 745 Kb 
Define.xml Round-Trip in SAS® Clinical Data Integration
  Julie Maddox, SAS Institute Inc., Cary, NC
Keywords: CDISC, xml
  Download the Super Demodownload (.pdf, 1061 Kb)
The Integration of SAS® Drug Development and SAS® Clinical Data Integration
  Julie Maddox, SAS Institute Inc., Cary, NC
  Download the Super Demodownload (.pdf, 982 Kb)
Creating Dataset-XML files with the SAS® Clinical Standards Toolkit
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: CDISC, xml
  Download the Super Demodownload (.pdf, 851 Kb)
Creating Define-XML Version 2 with the SAS® Clinical Standards Toolkit 1.6
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: CDISC, xml
  Download the Super Demodownload (.pdf, 808 Kb)
tweet!  Investigating the Irregular: Using Perl Regular Expressions
  Peter Eberhardt, Fernwood Consulting Group Inc., Toronto, ON, Canada
Keywords: regex perl regular expressions is08601 date cdisc
Pages: 18 Size: 143 Kb 

SAS Global Forum 2014

tweet!  Converting Clinical Database to SDTM: The SAS® Implementation
  Hong Chen
Keywords: clinical
Pages: 5 Size: 162 Kb 
tweet!  Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS®
  Karin LaPann, Terek Peterson
Pages: 19 Size: 736 Kb 
tweet!  Creating Define.xml v2 Using SAS® for FDA Submissions
  Qinghua (Kathy) Chen, James Lenihan
Keywords: xml
Pages: 20 Size: 259 Kb 

Western Users of SAS Software 2013

tweet!  Implementation of DEFINE.XML Generators using SAS Hash Objects and User-Defined Functions
  Lei Zhang, Celgene Corp.
Pages: 19 Size: 798 Kb 
tweet!  Introduction to the CDISC Standards
  Sandra Minjoe, Accenture Life Sciences
Keywords: Clinical Data Interchange Standards Consortium, pharmaceutical, biotechnology, medical device, protocol, CDASH, Lab, SDTM, SEND, ADaM, define.xml, ODM, glossary, BRIDG, SHARE, Controlled Terminolog ...
Pages: 10 Size: 317 Kb 

SouthEast SAS Users Group 2013

tweet!  Coding For the Long Haul With Managed Metadata and Process Parameters
  Mike Molter
Pages: 20 Size: 228 Kb 
tweet!  Imputing Dose Levels for Adverse Events
  John R Gerlach; Igor Kolodezh
Keywords: Adverse Events, Dose Levels
Pages: 8 Size: 286 Kb 
tweet!  The Baker Street Irregulars Investigate: Perl Regular Expressions and CDISC
  Peter Eberhardt; Wei Liu
Keywords: SAS perl regex ISO
Pages: 18 Size: 115 Kb 

Pharmaceutical Users Software Exchange 2013

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)
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)
Creating define.xml from a SAS Program
  Joergen Iversen, LEO Pharma A/S
Keywords: xml
  Download the presentationdownload (.pdf, 848 Kb)
Best Presentation
tweet!  Semantic Technology and CDISC Standards
  Frederik Malfait, IMOS Consulting; Scott Bahlavooni, Genentech
Keywords: CDISC Standards
Pages: 13 Size: 1840 Kb    Download the presentationdownload (.pdf, 3612 Kb)
tweet!  Overcoming Difficulties in Implementing RECIST Criteria
  Gerlind Ruhnke, Merck KGaA
Keywords: RECIST Tumor burden CDISC data handling oncology
Pages: 6 Size: 115 Kb    Download the presentationdownload (.pdf, 1590 Kb)
tweet!  Going Against the Flow: Backmapping SDTM Data
  Pantaleo Nacci, Novartis
Keywords: CDISC
Pages: 7 Size: 397 Kb    Download the presentationdownload (.pdf, 1606 Kb)
tweet!  Standardising the Standards - The Benefits of Consistency
  Nathan James, Roche
Keywords: data handling; sdtm; tool; pooling; consistency; dh06
Pages: 6 Size: 108 Kb    Download the presentationdownload (.pdf, 681 Kb)
tweet!  Taming Rave: How to Control Data Collection Standards?
  Dimitri Kutsenko, Entimo AG
Pages: 7 Size: 486 Kb    Download the presentationdownload (.pdf, 624 Kb)
tweet!  Time Travel for Librarians: Versioning Complex Library Metadata for Past, Present or Future Retrieval
  Nico De Leeuw, Business & Decision Life Sciences; Ine Felsenstein, Business & Decision Life Sciences
Keywords: CDISC Data Standards
Pages: 12 Size: 725 Kb    Download the presentationdownload (.pdf, 5302 Kb)
tweet!  An Introduction to SDTM - Part II
  Jennie McGuirk, ICON PLC
Keywords: CDISC
Pages: 1 Size: 54 Kb    Download the presentationdownload (.pdf, 1717 Kb)
tweet!  Two-way Ticket, Please...All aboard the SAS® Clinical Standards Toolkit 1.5 Express
  Gene Lightfoot, SAS Institute; Lex Jansen, SAS Institute
Keywords: clinical
Pages: 2 Size: 401 Kb    Download the posterdownload (.pdf, 493 Kb)
tweet!  Annotate CRFs and Keep Track of Them
  Rohit Banga, Biometrical Practice BIOP AG
Keywords: Annoate CRF;Track CRF;Rohit Banga;XFDF & SAS
Pages: 4 Size: 462 Kb    Download the posterdownload (.pdf, 1861 Kb)
tweet!  Are You out of Your Mind? CDISC Mappings Using the Mind Map Tool
  Niels Both, S-Cubed; Johannes Ulander, S-Cubed
Keywords: CDISC
Pages: 5 Size: 488 Kb    Download the presentationdownload (.pdf, 435 Kb)
CDISC Journey on Solid Tumor Studies using RECIST 1.1
  Kevin Lee, Cytel
Keywords: CDISC
  Download the presentationdownload (.pdf, 745 Kb)
Best Presentation
Evolving Regulatory Guidance on the Submission of Standardised Data
  James Johnson, Summit Analytical LLC
  Download the presentationdownload (.pdf, 1481 Kb)
On the Submission's Road with CDISC ADaM
  Romain Jegou, Business & Decision Life Sciences
Keywords: CDISC
  Download the presentationdownload (.pdf, 819 Kb)
tweet!  Designing ADaM Datasets: KISS the Complexity Goodbye
  David Jordan, SAS Institute; Bill Gibson, SAS Institute
Keywords: ADaM
Pages: 8 Size: 600 Kb    Download the presentationdownload (.pdf, 653 Kb)
Best Presentation
tweet!  A How-To Guide for Extending Controlled Terminology Using SAS Clinical Data Integration
  Melissa Martinez, SAS Institute
Keywords: CDISC, CDI, SAS Clinical Data Integration, Clinical Data Integration, controlled terminology, terminology, SDTM, define, define.xml, compliance, compliance checks, cterms, SDTM, controlled terminol ...
Pages: 12 Size: 573 Kb    Download the presentationdownload (.pdf, 6702 Kb)

Northeast SAS Users Group 2013

tweet!  The ADaM Solutions to Non-endpoints Analyses
  Chengxin Li, Boehinger Ingelheim
Pages: 12 Size: 609 Kb 
tweet!  Using SAS and D3.js to create interactive visualizations for ADaM and SDTM data.
  Nathan Mockler, Boehringer Ingelheim
Pages: 12 Size: 400 Kb 
tweet!  Automating Validation of Define.xml using SAS®
  Prafulla Girase, Biogen Idec Inc,; Robert Agostinelli, Sunovion Pharmaceuticals Inc
Keywords: xml
Pages: 8 Size: 400 Kb 

Pharmaceutical SAS Users Group 2013

tweet!  Running OpenCDISC in SAS
  Kevin Lee, Cytel Inc., Chesterbrook, PA
Keywords: CDISC
Pages: 7 Size: 243 Kb 
tweet!  A Generic Concept to Handle SDTM (and other CDISC) Data Sets
  Peter Schaefer, BASS, LLC, Raleigh, NC
Keywords: CDISC
Pages: 8 Size: 386 Kb 
Best Paper
tweet!  Automating Validation of Define.xml using SAS®
  Prafulla Girase, Biogen Idec, Cambridge, MA; Robert Agostinelli, Sunovion Pharmaceuticals, Marlborough, MA
Keywords: Define.xml, XMLMap, XML Mapper, CDISC
Pages: 8 Size: 437 Kb 
tweet!  SDTM Harmonization in the Absence of CDASH - A Modularized Approach to Domain Programming
  Annie Guo, ICON Clinical Research, San Francisco, CA
Keywords: CDISC SDTM Controlled Terminology QS C-SSRS Naming Convention Normalize Transpose Template Programming
Pages: 12 Size: 477 Kb 
Best Paper
tweet!  The Baker Street Irregulars Investigate: Perl Regular Expressions and CDISC
  Peter Eberhardt, Fernwood Consulting Group Inc., Toronto, ON, Canada; Wei (Wesley) Liu, SAS Research and Development, Beijing, China
Keywords: PERL CDISC ISO 8601 ISO8601 dates regex regular expression
Pages: 18 Size: 117 Kb 
tweet!  OpenCDISC: Beyond Point and Click
  Frank DiIorio, CodeCrafters, Inc., Philadelphia, PA
Keywords: OpenCDISC, dataset validation, metadata, CDISC, ADaM, SDTM
Pages: 12 Size: 1091 Kb 
tweet!  Bring Excel file with SDTM data in multiple sheets to SAS®
  Mindy Wang, Independent Consultant, North Potomac, MD
Keywords: STDM;Excel, CDISC
Pages: 7 Size: 1304 Kb 
tweet!  Methods to Derive COVAL-COVALn in CO Domain
  Chunxia Lin, inVentiv Health Clinical, Indianapolis, IN
Keywords: CDISC, SDTM, COMMENTS, COVAL, TRUNCATION
Pages: 8 Size: 97 Kb 
tweet!  When Asked for Subject Incidences, Go Ahead and FREQ OUT
  Rod Norman, Inventiv Health Clinical, San Diego, CA
Keywords: ADaM, ODS Output, FREQ, Adverse Events
Pages: 8 Size: 59 Kb 
Best Paper
tweet!  Leveraging SDTM Standards to Cut Datasets at Any Visit
  Anthony L. Feliu, Genzyme, Cambridge, MA; Stephen W. Lyons, Genzyme, Cambridge, MA
Keywords: SDTM, CDISC, interim analysis, SAS/macro
Pages: 12 Size: 240 Kb 
tweet!  Programming Validation Tips prior to using OpenCDISC validator
  Dany Guerendo, STATProg LLC, Morrisville, NC
Keywords: CDISC
Pages: 12 Size: 859 Kb 
tweet!  Implementation Considerations for PARAM/PARAMCD Using ADaM BDS
  Karl Miller, inVentiv Health Clinical, Lincoln, NE; J.J. Hantsch, inVentiv Health Clinical, Chicago, IL
Keywords: CDISC
Pages: 5 Size: 47 Kb 
tweet!  Designing and Tuning ADaM Datasets
  Songhui Zhu, K&L Consulting Services, Fort Washington, PA
Keywords: CDISC
Pages: 9 Size: 228 Kb 
tweet!  Macro %D_ADSL - Automating ADSL Creation from Metadata File
  Jianhua (Daniel) Huang, Celgene Corporation, Basking Ridge, NJ
Keywords: Macro, ADaM
Pages: 9 Size: 78 Kb 
tweet!  Data Standards Will Be Required: Challenges for Medical Device Submissions
  Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA; Kit Howard, Kestrel Consultants, Ann Arbor, MI; Fred Wood, Accenture Life Sciences, Wayne, PA; Rhonda Facile, CDISC, Austin, TX
Keywords: CDISC, CDRH, Devices
Pages: 5 Size: 73 Kb 
tweet!  From Standards that Cost To Standards that Save: Cost Effective Standards Implementation
  Jeffrey Abolafia, Rho Inc., Chapel Hill, NC; Frank DiIorio, CodeCrafters, Inc., Philadelphia, PA
Keywords: CDISC, Data Standards
Pages: 9 Size: 74 Kb 
tweet!  Standardizing the Standards: A Road Map for Establishing, Implementing and Unifying Standards in Your Organization
  Amy Caison, PPD, Wilmington, NC; Jhelum Naik, PPD, Wilmington, NC; Tammy Jackson, PPD, Wilmington, NC
Keywords: Data Standards; CDISC; CDISC SDTM; Knowledge management; PDUFA V
Pages: 9 Size: 239 Kb 
tweet!  The Y2K17 Bug! Using Metadata to Respond to PDUFA V Requirements
  Vincent J. Amoruccio, Alexion Pharmaceuticals, Cheshire, CT
Keywords: PDUFA, CDISC, Metadata, SDTM, ADaM, Dataset-Level Metadata, Variable-Level Metadata, Parameter Value-Level Metadata, Result-Level Metadata, Tables, Listings, Figures
Pages: 12 Size: 416 Kb 
Best Paper
tweet!  Considerations in the Use of Timing Variables in Submitting SDTM-Compliant Datasets
  Jerry Salyers, Accenture Life Sciences, Wayne, PA; Richard Lewis, Accenture Life Sciences, Wayne, PA; Fred Wood, Accenture Life Sciences, Wayne, PA
Keywords: SDTM, Study Reference Period, Timing variable, Relative time point variable, nominal time point, CDISC
Pages: 6 Size: 132 Kb 
tweet!  Good vs Better SDTM: Limitations as Operational Model
  Henry B. Winsor, Affymax, Inc, Palo Alto, CA; Mario Widel, Roche Molecular Systems, Inc., Pleasanton, CA
Keywords: CDISC, SDTM, Operational Model
Pages: 4 Size: 129 Kb 
tweet!  Mapping Unique Aspects of Implantable Medical Device Study Data to CDISC SDTM Medical Device Domains
  Timothy L Bullock, Allergan Medical, Santa Barbara, CA; Sini Nair, Allergan Medical, Santa Barbara, CA; Ramkumar Krishnamurthy, Allergan Medical, Santa Barbara, CA; Todd M Gross, Allergan Medical, Santa Barbara, CA
Keywords: SDTM Device Implant, CDISC
Pages: 12 Size: 435 Kb 
tweet!  Considerations in Data Modeling when Creating Supplemental Qualifiers Datasets in SDTM-Based Submissions
  Fred Wood, Accenture Life Sciences, Wayne, PA
Keywords: CDISC
Pages: 12 Size: 258 Kb 
tweet!  Some Strategies for Validating Your Data before Submission
  Frank Roediger, SAS Institute, Cary, NC; Sandeep Juneja, SAS Institute, Cary, NC
Keywords: Character Field Length;SDTM Warehouse;V5 Transport File;Clinical Standards Toolkit;CST
Pages: 8 Size: 539 Kb 
tweet!  Hands-On ADaM ADAE Development
  Sandra Minjoe, Accenture Life Sciences, Wayne, PA
Keywords: CDISC, ADaM, ADAE, hierarchy, occurrence, MedDRA, BDS, ADSL
Pages: 7 Size: 327 Kb 
tweet!  Using the SAS® Clinical Standards Toolkit 1.5 to Import CDISC ODM Files
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: SAS, CDISC, ODM, XML, SAS® Clinical Standards Toolkit
Pages: 28 Size: 1240 Kb    Download the workshop filesdownload (.zip, 11810 Kb)
tweet!  SDTM, ADaM and define.xml with OpenCDISC®
  Angela Ringelberg, inVentiv Health Clinical, Cary, NC; Tracy Sherman, inVentiv Health Clinical, Cary, NC
Keywords: CDISC, xml
Pages: 16 Size: 2358 Kb 
tweet!  Due (Data) Diligence: Study Data Review for Acquisitions
  Adam Young, ViroPharma Incorporated, Exton, PA; Steve Kirby, ViroPharma Incorporated, Exton, PA
Keywords: Diligence, CDISC, ADaM, SDTM, define.xml, blankcrf.pdf, FDA, CDER, CBER, Submission
Pages: 6 Size: 399 Kb 
tweet!  Introduction to the CDISC Standards
  Sandra Minjoe, Accenture Life Sciences, Wayne, PA
Keywords: CDISC, FDA, data, metadata, protocol, cdash, lab, sdtm, send, adam, define, odm, glossary, bridg, share, terminology, opencdisc
Pages: 10 Size: 316 Kb 
tweet!  Derived observations and associated variables in ADaM datasets
  Arun Raj Vidhyadharan, inVentiv Health Clinical, Somerset, NJ
Keywords: CDISC
Pages: 7 Size: 315 Kb 
tweet!  ADaM Datasets for Graphs
  Kevin Lee, Cytel, Inc., Chesterbrook, PA; Chris Holland, Amgen, Rockville, MD
Keywords: CDISC
Pages: 15 Size: 264 Kb 
tweet!  Flags for Facilitating Statistical Analysis Using CDISC Analysis Data Model
  Chun Feng, Celerion Inc., Lincoln, NE; Xiaopeng Li, Celerion Inc., Lincoln, NE; Nancy Wang, Celerion Inc., Lincoln, NE
Keywords: ADaM, Analysis Flags, Statistical Analysis, CDISC
Pages: 6 Size: 54 Kb 
tweet!  Traceability in the ADaM Standard
  Ed Lombardi, SynteractHCR, Inc., Carlsbad, CA
Keywords: CDISC
Pages: 8 Size: 257 Kb 
Using the SAS® Clinical Standards Toolkit 1.5 for define.xml Creation
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: CDISC, xml
  Download the Super Demodownload (.pdf, 935 Kb)
tweet!  Mission Possible: Your Assignment is to Validate Output for a Study
  Susan Fehrer Coulson, BioClin, Inc., Emporia, KS; Kevin R. Coulson, Emporia State University, Emporia, KS
Keywords: Validation, SDTM, SAS
Pages: 7 Size: 254 Kb 
tweet!  Defensive Programming and Error-handling: The Path Less Travelled
  Tracy Sherman, InVentiv Health Clinical, Cary, NC; Angela Ringelberg, InVentiv Health Clinical, Cary, NC
Keywords: defensive programming; defensive coding; error-handling; cdisc
Pages: 9 Size: 349 Kb 

SAS Global Forum 2013

tweet!  The Hash-of-Hashes as a "Russian Doll" Structure: An Example with XML Creation
  Joseph Hinson
Keywords: xml
Pages: 21 Size: 303 Kb 
tweet!  Adding New Rows in the ADaM Basic Data Structure: When and How
  Mario Widel, Sandra Minjoe
Pages: 12 Size: 693 Kb 
tweet!  Using the ADaM ADAE Structure for Non-AE Data
  Mario Widel, Sandra Minjoe
Pages: 13 Size: 760 Kb 
tweet!  Developing Your SDTM Programming Toolkit
  David Scocca
Keywords: SDTM, macro, CDISC
Pages: 10 Size: 68 Kb 
tweet!  From SDTM to ADaM
  Bob Lan, Regan Li, Sai Ma, Suwen Li
Pages: 7 Size: 605 Kb    Download the posterdownload (.pdf, 204 Kb)
tweet!  A Practical Approach to Creating Define.XML by Using SDTM Specifications and Excel functions
  Amos Shu
Keywords: xml
Pages: 7 Size: 274 Kb    Download the posterdownload (.pdf, 151 Kb)
tweet!  A Simple Macro to Minimize Data Set Size
  Amos Shu
Keywords: macro
Pages: 4 Size: 192 Kb    Download the posterdownload (.pdf, 126 Kb)
tweet!  Implementing CDISC, SDTM, and ADaM in a SAS® Environment
  Pankaj Bhardwaj
Pages: 4 Size: 510 Kb    Download the posterdownload (.pdf, 493 Kb)
A Preventive Approach for Automatic Checking of CDISC ADaM Metadata to Detect Noncompliance
  Min Chen, Tathabbai Pakalapati, Xiangchen Cui
  Download the posterdownload (.pdf, 248 Kb)

Northeast SAS Users Group 2012

tweet!  Step by Step Approach to Port CDISC SAS® Data Integration Repositories on Cross Platforms Using %OMAPORT Macro
  Salman Ali, SAS Professional Services
Keywords: macro
Pages: 6 Size: 190 Kb 
tweet!  Harnessing the Power of SAS® ISO 8601 Informats, Formats, and the CALL IS8601_CONVERT Routine
  Kim Wilson, SAS Institute Inc.
Pages: 15 Size: 127 Kb 

South-Central SAS Users Group 2012

tweet!  POSTER: ADaM Implications of the CDER Data Standards Common Issues Document
  Sandra Minjoe
Pages: 6 Size: 165 Kb 

Pharmaceutical Users Software Exchange 2012

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)
Best Presentation
tweet!  Parsing ISO 8601 Standard Partial Dates using Perl Regular Expressions
  Mark Crangle, ICON
Pages: 8 Size: 426 Kb    Download the presentationdownload (.pdf, 934 Kb)
JMP Clinical® 4.0
  Valérie Nedbal, SAS Institute
Keywords: clinical
  Download the presentationdownload (.pdf, 8467 Kb)
tweet!  Reprogramming a Many-to-Many Merge with Hash Objects
  David Garbutt, Freelance
Keywords: PhUSE, PhUSE 2012, SAS, examples, clinical reporting, hash object, content addressible arrays, CDISC validation, controlled terminologies
Pages: 24 Size: 8858 Kb    Download the presentationdownload (.pdf, 9582 Kb)
Controlling Controlled Terminology
  Ryan Burns, Rho Inc
  Download the presentationdownload (.pdf, 1854 Kb)
Best Presentation
tweet!  Legacy Data Conversion: A Journey of Discovery
  Pantaleo Nacci, Novartis Vaccines & Diagnostics Srl
Keywords: SDD datawarehouse CDISC SDTM legacy
Pages: 8 Size: 515 Kb    Download the presentationdownload (.pdf, 696 Kb)
Best Presentation
tweet!  An Introduction to SDTM, 298 Pages in 20 Minutes?
  Jennie McGuirk, ICON
Keywords: CDISC
Pages: 8 Size: 997 Kb    Download the presentationdownload (.pdf, 2116 Kb)
tweet!  Validation CDISC Data with the SAS Clinical Standards Toolkit
  Nicolai Haag, HMS Analytical Software
Keywords: CDISC, clinical
Pages: 1 Size: 1077 Kb    Download the posterdownload (.pdf, 1078 Kb)
tweet!  Simplifying SAS Clinical Standards Toolkit - Where's the Easy Button?
  Gene Lightfoot, SAS Institute Inc
Keywords: clinical
Pages: 6 Size: 237 Kb    Download the posterdownload (.pdf, 1314 Kb)
tweet!  Define.xml content validation - SAS® based solution
  Sam Tomioka, Sunovion; Steven Huang, Sunovion
Keywords: xml
Pages: 8 Size: 231 Kb    Download the posterdownload (.pdf, 189 Kb)
tweet!  ADaM in a Pool! A Concept on how to Create Integrated ADaM Datasets
  Alexandru Cuza, UCB BioSciences GbmH
Keywords: Integrated analysis; ADaM; CDISC
Pages: 3 Size: 108 Kb    Download the posterdownload (.pdf, 4922 Kb)
tweet!  One Approach to a Metadata and Data Standards Repository
  Bill Gibson, SAS
Pages: 4 Size: 112 Kb    Download the posterdownload (.pdf, 120 Kb)
tweet!  Controlling Controlled Terminology
  Ryan Burns, Rho
Keywords: Controlled Terminology; Metadata
Pages: 5 Size: 79 Kb    Download the posterdownload (.pdf, 631 Kb)
tweet!  Cost Effective Standards Implementation: A New Paradigm for the Drug Development Life Cycle
  Jeff Abolafia, Rho; Frank Dilorio, CodeCrafters Inc
Keywords: CDISC, Data Standards
Pages: 9 Size: 135 Kb    Download the presentationdownload (.pdf, 3120 Kb)
Define.xml for ADaM: From Results to SDTM
  Dimitri Kutsenko, Entimo AG
Keywords: CDISC, xml
  Download the presentationdownload (.pdf, 108 Kb)
tweet!  SAS Clinical Standards Toolkit 1.5 - How Do I Know My Metadata is Right?
  Gene Lightfoot, SAS Institute Inc
Keywords: clinical
Pages: 14 Size: 583 Kb    Download the presentationdownload (.pdf, 3389 Kb)
Best Presentation
tweet!  Let SAS Handle your CDISC Compliance Check: Automating OpenCDISC Validator in SAS
  Edwin van Stein, Chiltern International BV; Best Wiki
Keywords: SAS CDISC OpenCDISC Validator SDTM ADaM Define.xml
Pages: 8 Size: 501 Kb    Download the presentationdownload (.pdf, 1286 Kb)
tweet!  Controlling OpenCDISC Using R
  Martin Gregory, Merck Serono
Keywords: cdisc;validation;r
Pages: 7 Size: 125 Kb    Download the presentationdownload (.pdf, 426 Kb)
tweet!  Deep Dive into ODM Validation
  Ronald Steinhau, Entimo AG
Pages: 3 Size: 88 Kb    Download the presentationdownload (.pdf, 737 Kb)

SouthEast SAS Users Group 2012

tweet!  The SDTM Programming Toolkit
  David Scocca
Keywords: SDTM, macro, CDISC
Pages: 10 Size: 84 Kb 
tweet!  An Introduction to the Clinical Standards Toolkit
  Mike Molter
Keywords: clinical
Pages: 13 Size: 123 Kb 
tweet!  Developing a Complete Picture of Patient Safety in Clinical Trials
  Richard Zink
Keywords: Adverse Event, CDISC, Safety Review, clinical
Pages: 5 Size: 386 Kb 
tweet!  A Standard SAS Program for Corroborating OpenCDISC Error Messages
  John R Gerlach
Keywords: SAS, OpenCDISC
Pages: 11 Size: 295 Kb 
tweet!  Generating SUPPQUAL Domains from SDTM-Plus Domains
  John R Gerlach
Keywords: SAS, CDISC, SUPPQUAL
Pages: 6 Size: 230 Kb 

Western Users of SAS Software 2012

tweet!  Developing Integrated Summary of Safety Database using CDISC Standards
  Rajkumar Sharma, Genentech, Inc.
Pages: 7 Size: 75 Kb 

Pharmaceutical SAS Users Group China 2012

Challenge in Legacy Studies Converting to CDISC – A Case Study from MacroStat
  Weijin Gan
Keywords: CDISC, macro
  Download the slidesdownload (.ppt, 406 Kb)
Taste of SDTM in Real Time
  Changhong Shi; Beilei Xu
Keywords: CDISC
  Download the slidesdownload (.ppt, 300 Kb)
tweet!  Clinical Review on iPad with DEFINE.XML
  Sy Truong
Keywords: xml
Pages: 10 Size: 1201 Kb 

Pharmaceutical SAS Users Group 2012

tweet!  A Standard SAS Program for Corroborating OpenCDISC Error Messages
  John R. Gerlach, TAKE Solutions, Princeton, NJ; Ganesh Sankaran Thangavel, TAKE Solutions, Princeton, NJ
Keywords: CDISC, OpenCDISC, Validation
Pages: 12 Size: 214 Kb 
tweet!  Creating Define.pdf with SAS® Version 9.3 ODS RTF
  Elizabeth Li, PharmaStat, LLC, Newark, CA; Carl Chesbrough, PharmaStat, LLC, Newark, CA
Pages: 36 Size: 736 Kb 
tweet!  OpenCDISC Plus
  Annie Guo, ICON Clinical Research, San Francisco, California
Keywords: OpenCDISC Plus SDTM Comparison Comments Template
Pages: 10 Size: 269 Kb 
tweet!  CDISC SDTM CONVERSION IN ISS/ISE STUDIES: TOOLS
  Balaji Ayyappan, PharmaNet/i3, Cary, NC
Keywords: CDISC
Pages: 6 Size: 277 Kb 
tweet!  From InForm EDC Data to SAS Datasets using SAS Clinical Data Integration – Real Time
  Jitesh Nagaria, SAS Institute, Cary, NC
Keywords: InForm EDC, SAS Clinical Data Integration,; Clinical Standard Toolkit, ODM XML
Pages: 12 Size: 807 Kb 
tweet!  Automatic Version Control and Track Changes of CDISC ADaM Specifications for FDA Submission
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Min Chen, Vertex Pharmaceuticals, Cambridge, MA
Keywords: CDISC ADaM, Version Control, Tracking Changes, FDA Submission, Automation, Macro
Pages: 8 Size: 113 Kb 
tweet!  Automatic Detection and Identification of Variables with All Missing Values in SDTM/ADaM Datasets for FDA Submission
  Min Chen, Vertex Pharmaceuticals, Cambridge, MA; Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA
Keywords: CDISC SDTM, ADaM, FDA Submission, Empty Variables, Automation, Macro, Core Variable Categories
Pages: 7 Size: 110 Kb 
tweet!  The application of variable-dependent macro on SDTM conversion
  Mindy Wang, Independent Consultant, North Potomac, MD
Keywords: SDTM, CDISC, macro
Pages: 9 Size: 755 Kb 
tweet!  One Macro Call to a Table with both Frequency and Summary Elements from a Subject-Level Dataset
  Wayne Zhong, Octagon Research Solutions Inc., Wayne, PA
Keywords: macro, table, wide dataset, ADSL
Pages: 9 Size: 250 Kb 
Best Paper
tweet!  Transform Incoming Lab Data into SDTM LB Domain with Confidence
  Anthony L. Feliu, Genzyme, A Sanofi Company, Cambridge, MA
Keywords: CDISC, SDTM, data standards
Pages: 27 Size: 328 Kb 
tweet!  SAS File Design: Guidelines for Statisticians and Data Managers
  Douglas Zirbel, Independent Consultant, St Louis, MO
Keywords: file design, database, cdisc, normalization, normal form, checklist
Pages: 6 Size: 304 Kb 
tweet!  Seven New SDTM Domains for Medical Devices
  Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA; Fred Wood, Octagon Research Solutions, Wayne, PA; Rhonda Facile, CDISC, TX; Kit Howard, Kestrel Consultants, MI
Keywords: CDISC, Medical Devices, SDTM
Pages: 4 Size: 103 Kb 
tweet!  SDTM Domain Mapping with Structured Programming Methodology
  Chengxin Li, Boehringer Ingelheim, Ridgefield, CT; Jing-Wei Gao, Boehringer Ingelheim, Ridgefield, CT; Nancy Bauer, Boehringer Ingelheim, Ridgefield, CT
Keywords: SDTM, Domain, Mapping, Structured Programming, CDISC
Pages: 8 Size: 735 Kb 
tweet!  Generating SUPPQUAL Domains From SDTM-Plus Domains
  John R. Gerlach, TAKE Solutions, Inc., Princeton, NJ; Glenn O'Brien, Independent Consultant, Roseland, NJ
Keywords: CDISC, SUPPQUAL, SDTM-Plus
Pages: 6 Size: 192 Kb 
tweet!  Avoiding a REL-WRECK; Using RELREC Well
  Karl Miller, Pharmanet-i3, Lincoln, NE; J.J. Hantsch, Pharmanet-i3, Chicago, IL; Janet Stuelpner, SAS Institute Inc., New Canaan, CT
Pages: 6 Size: 64 Kb 
tweet!  Considerations in the Submission of Exposure Data in an SDTM-Compliant Format
  Fred Wood, Octagon Research Solutions, Wayne, PA; Jerry Salyers, Octagon Research Solutions, Wayne, PA; Richard Lewis, Octagon Research Solutions, Wayne, PA
Keywords: CDISC
Pages: 4 Size: 39 Kb 
tweet!  Considerations in the Submission of Pharmacokinetics (PK) Data in an SDTM-Compliant Format
  Fred Wood, Octagon Research Solutions, Wayne, PA; Peter Schaefer, Certara, Cary, NC; Richard Lewis, Octagon Research Solutions, Wayne, PA
Keywords: CDISC
Pages: 8 Size: 134 Kb 
tweet!  Experiences in Leading a Company-Wide First CDISC Filing from a Programming Perspective
  Sho-Rong Lee, Genentech, a Member of the Roche Group, South San Francisco, CA
Keywords: CDISC
Pages: 6 Size: 214 Kb 
tweet!  “Analysis-ready” – Considerations, Implementations, and Real World Applications
  Ellen (Zihui) Lin, Amgen Inc, Thousand Oaks, CA; Beiying Ding, Amgen Inc, Thousand Oaks, CA
Pages: 6 Size: 273 Kb 
tweet!  A Complex ADaM dataset? Three different ways to create one.
  Kevin Lee, Cytel, Inc., Chesterbrook, PA
Keywords: A complex ADaM dataset, ADaM+ , SDTM, SDTM+, Intermediate ADaM dataset, CDISC
Pages: 11 Size: 191 Kb 
tweet!  Building Flexible ADaM Analysis Variable Metadata
  Songhui Zhu, K & L Consulting Services, Fort Washington, PA; Lin Yan, Celgene Corporation, Summit, NJ
Keywords: CDISC
Pages: 10 Size: 193 Kb 
Best Paper
tweet!  Common Misunderstandings about ADaM Implementation
  Nate Freimark, Theorem Clinical Research, King of Prussia, PA; Susan Kenny, Amgen Inc, Thousand Oaks, CA; Jack Shostak, Duke Clinical Research Institute, Durham, NC; John Troxell, John Troxell Consulting LLC, Bridgewater, NJ
Keywords: ADaM, ADaMIG, CDISC, FDA
Pages: 10 Size: 98 Kb 
tweet!  Creating an Integrated Summary of Safety Database using CDISC ADaM : Challenges, Tips and Things to Watch Out
  Rajkumar Sharma, Genentech Inc., A member of the Roche Group, South San Francisco, CA
Keywords: CDISC
Pages: 7 Size: 76 Kb 
tweet!  CDISC ADaM Application: Does All One-Record-per-Subject Data Belong in ADSL?
  Sandra Minjoe, Octagon Research Solutions, Wayne, PA
Keywords: CDISC, ADaM, one-record-per-subject, ADSL, BDS, baseline characteristics, FDA, CDER, reviewer, traceability, per-protocol, derived parameter, analysis parameter, multivariate analysis, transpose
Pages: 10 Size: 409 Kb 
tweet!  Multiple Applications of ADaM Time-to-Event Datasets
  Huei-Ling Chen, Merck Sharp & Dohme Corp., Whitehouse Station, NJ; Helen Wang, Merck Sharp & Dohme Corp., Whitehouse Station, NJ
Keywords: CDISC
Pages: 6 Size: 40 Kb 
tweet!  An Innovative ADaM Programming Tool for FDA Submission
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Min Chen, Vertex Pharmaceuticals, Cambridge, MA; Tathabbai Pakalapati, Vertex Pharmaceuticals, Cambridge, MA
Keywords: CDISC ADaM, FDA Submission, Innovative, Automation, Compliance Checking, Version Control, Tracking Changes, Consistency Checking, Empty Variable Checking, define.xml
Pages: 25 Size: 372 Kb 
tweet!  Creating Analysis Data Marts from SDTM Warehouses
  Frank L. Roediger, SAS Institute, Inc., Cary, North Carolina
Keywords: SDTM;Data Warehouse;Data Mart;Oceans;Pools, CDISC
Pages: 9 Size: 481 Kb 
tweet!  Harnessing the Power of SAS ISO 8601 Informats, Formats, and the CALL IS8601_CONVERT Routine
  Kim Wilson, SAS Institute Inc., Cary, NC, USA
Pages: 15 Size: 82 Kb 
tweet!  An Introduction to the Clinical Standards Toolkit and Clinical Data Compliance Checking
  Mike Molter, d-Wise Technologies, Raleigh, NC
Keywords: CDISC
Pages: 14 Size: 119 Kb    Download the workshop filesdownload (.zip, 1044 Kb)
tweet!  Using the SAS® Clinical Standards Toolkit 1.4 for define.xml creation
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: define.xml, CDISC, SDTM, SAS
Pages: 30 Size: 1189 Kb    Download the workshop filesdownload (.zip, 4268 Kb)
tweet!  Creating the Time to Event ADaM Dataset: The Nuts and Bolts
  Nancy Brucken, PharmaNet/i3, Ann Arbor, MI; Paul Slagle, United BioSource Corp., Ann Arbor, MI
Keywords: ADTTE, time-to-event, ADaM, analysis dataset, time to event, CDISC
Pages: 7 Size: 305 Kb    Download the workshop filesdownload (.zip, 8777 Kb)
tweet!  SDTM, ADaM and define.xml with OpenCDISC®
  Matt Becker, PharmaNet/i3, Cary, NC
Keywords: CDISC, xml
Pages: 14 Size: 4799 Kb 
tweet!  SDTM Domain Development on the Critical Path – Strategies for Success
  David C. Izard, Octagon Research Solutions, Wayne, PA
Keywords: David C Izard, CDISC, SDTM, SEND, ADaM, CRT, Regulatory Submission
Pages: 5 Size: 133 Kb 
tweet!  Streamlining Regulatory Submission with CDISC/ADaM Standards for Non-standard Pharmacokinetic/Pharmacodynamic Analysis Datasets
  Xiaopeng Li, Celerion Inc., Lincoln, NE; Katrina Canonizado, Celerion Inc., Lincoln, NE; Chun Feng, Celerion Inc., Lincoln, NE; Nancy Wang, Celerion Inc., Lincoln, NE
Keywords: CDISC, ADaM, analysis data, Pharmacokinetic, Pharmacodynamic, thorough QT study, reproductive safety study, urine analysis study
Pages: 6 Size: 397 Kb 
tweet!  One at a Time; Producing Patient Profiles and Narratives
  J.J. Hantsch, Pharmanet-i3, Chicago, IL; Janet Stuelpner, SAS Institute Inc., New Canaan, CT
Keywords: Patient Profiles, Narratives, SDTM
Pages: 6 Size: 277 Kb 
tweet!  ADaM Implications from the “CDER Data Standards Common Issues” and SDTM Amendment 1 Documents
  Sandra Minjoe, Octagon Research Solutions, Wayne, PA
Keywords: CDER, FDA, CDISC, ADaM, SDTM, issues, reviewer, submission, ADSL, imputation, baseline characteristics, traceability, consistency, study day, integration
Pages: 6 Size: 171 Kb 
tweet!  Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Min Chen, Vertex Pharmaceuticals, Cambridge, MA
Keywords: CDISC ADaM, Consistency Checking, Controlled Terminology, Value Level Metadata, define.xml, FDA Submission, Automation, Macro
Pages: 15 Size: 262 Kb 
tweet!  Automate Validation of CDISC ADaM Variable Label Compliance
  Wayne Zhong, Octagon Research Solutions Inc., Wayne, PA
Keywords: label, like, CDISC, ADaM
Pages: 4 Size: 166 Kb 

SAS Global Forum 2012

tweet!  Using Custom Data Standards in SAS® Clinical Data Integration
  Michael Kilhullen
Keywords: clinical
Pages: 11 Size: 306 Kb 
tweet!  Defining the Development Process and Governance of Implementing ADaM within an Organization
  Chris Decker
Pages: 11 Size: 421 Kb 
tweet!  Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission
  Xiangchen Cui, Min Chen
Keywords: xml
Pages: 15 Size: 277 Kb 
tweet!  SAS® Macros to Transpose SDTM Data Sets Automatically
  Chunmao Wang
Keywords: macro
Pages: 7 Size: 41 Kb 
tweet!  Using SAS® Macros to Remediate Existing SDTM Data Sets for New Drug Application (NDA) Submission
  Yanwei Han
Keywords: macro
Pages: 4 Size: 50 Kb 
Best Contributed Paper
tweet!  A Standard SAS® Program for Corroborating Clinical Data Interchange Standards Consortium Error Messages
  John R. Gerlach, Ganesh Sankaran Thangavel
Keywords: SAS, OpenCDISC, clinical
Pages: 12 Size: 232 Kb 
tweet!  SUPPQUAL—Where's My Mommy?
  Sandra VanPelt Nguyen
Keywords: CDISC, SDTM, SUPPQUAL
Pages: 8 Size: 1095 Kb 
tweet!  Examples of Building Traceability in CDISC ADaM Datasets for FDA Submission
  Xiangchen Cui, Hongyu Liu, Tathabbai Pakalapati
Pages: 14 Size: 208 Kb 
tweet!  One at a Time; Producing Patient Profiles and Narratives
  Joseph J. Hantsch, Janet Stuelpner
Pages: 6 Size: 275 Kb 

South-Central SAS Users Group 2011

CDISC ADaM Application: One-Record-Per-Subject Data That Doesn't Belong in ADSL
  Sandra Minjoe

SouthEast SAS Users Group 2011

tweet!  Validating Controlled Terminology in SDTM Domains
  John Gerlach
Pages: 11 Size: 592 Kb 
tweet!  Proc CDISC: Implementation and Assessments
  Sheetal Nisal; Shilpa Edupganti
Pages: 6 Size: 71 Kb 

Western Users of SAS Software 2011

tweet!  How to easily convert clinical data to CDISC SDTM
  Ale Gicqueau, Clinovo
Pages: 9 Size: 380 Kb 
tweet!  Use CDISC SDTM as a data middle-tier to streamline your SAS® infrastructure
  Kalyani Chilukuri, clinovo
Pages: 8 Size: 1004 Kb 
tweet!  Clinical Data Review on iPad® with DEFINE.XML
  Sy Truong, Meta-Xceed, Inc.
Pages: 10 Size: 1161 Kb 

Pharmaceutical Users Software Exchange 2011

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
Keywords: ADaM CDISC Wide ADSLSUPP BDSL
Pages: 5 Size: 191 Kb    Download the presentationdownload (.ppt, 728 Kb)
tweet!  A SAS macro to check SDTM domains against controlled terminology
  Guido Wendland, UCB Biosciences GmbH
Keywords: CDISC, macro
Pages: 10 Size: 635 Kb    Download the presentationdownload (.ppt, 3063 Kb)
tweet!  Much ADaM about Nothing - a PROC Away in a Day
  Endri Endri, i3; Rowland Hale, i3
Pages: 8 Size: 156 Kb    Download the presentationdownload (.ppt, 10553 Kb)
tweet!  JMP Clinical for the Exploration of Legacy Vaccine Trials
  Robert Eric Huisden, OCS Biometric Support
Keywords: clinical
Pages: 4 Size: 92 Kb    Download the posterdownload (.pdf, 554 Kb)
tweet!  Rebuilding define.pdf by reading Word and XFDF files
  David Garbutt, BIOP AG
Keywords: SAS, V9.2, unicode, XML map, XML engine, FDA, Data Definition Document
Pages: 23 Size: 1773 Kb    Download the posterdownload (.pdf, 2168 Kb)
tweet!  Extension of the Six Steps Approach: How to go from an SDTM finding domain to an ADaM-compliant AD
  Carl Herremans, Merck Sharpe & Dohme (Europe); Qian Wang, Merck Sharpe & Dohme (Europe)
Keywords: CDISC
Pages: 5 Size: 179 Kb    Download the posterdownload (.pdf, 140 Kb)
tweet!  FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards
  Peter Van Reusel, Business & Decision Life Sciences; Tina Apers, Business & Decision Life Sciences
Keywords: FDA;CDISC ;SDTM;submission
Pages: 3 Size: 120 Kb    Download the presentationdownload (.ppt, 2839 Kb)
Understanding NDA/BLA Clinical Data Submission
  Dirk Spruck, Accovion
Keywords: clinical
  Download the presentationdownload (.pdf, 1020 Kb)
tweet!  Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata
  Philippe Verplancke, XClinical GmbH
Keywords: CDISC, xml
Pages: 5 Size: 1409 Kb    Download the presentationdownload (.pdf, 1409 Kb)
tweet!  "Overnight" Conversion to SDTM Datasets - Ready for SDTM Submission
  Niels Mathiesen, Mathiesen & Mathiesen
Keywords: CDISC
Pages: 7 Size: 1780 Kb    Download the presentationdownload (.pdf, 2535 Kb)
tweet!  SAS Clinical Data Integration
  Bill Gibson, SAS
Keywords: clinical
Pages: 2 Size: 64 Kb 
tweet!  Implementation of CDISC standards supported by global mapping process and metadata library
  Dimitri Kutsenko, Entimo AG
Keywords: CDISC
Pages: 5 Size: 119 Kb    Download the presentationdownload (.ppt, 1272 Kb)
tweet!  Implementing ADaM Using the SAS® Clinical Standards Toolkit
  Gene Lightfoot, SAS Institute Inc
Keywords: clinical
Pages: 12 Size: 674 Kb    Download the presentationdownload (.ppt, 2339 Kb)

Midwest SAS Users Group 2011

tweet!  How to Use SDTM Definition and ADaM Specifications Documents to Facilitate SAS Programming
  Yan Liu, Sanofi Pasteur, Beijing, China
Pages: 5 Size: 291 Kb 
tweet!  Is It Time to Upgrade CDISC SDTM from v1.1/v3.1.1 to v1.2/v3.1.2?
  Susan M. Fehrer, BioClin, Inc., Emporia, KS
Pages: 3 Size: 133 Kb 
tweet!  Creating a Clean Multi-Tabbed SDTM Dataset Specification Spreadsheet
  Dongju Liu, Advanced Clinical, Deerfield, IL; William Conover, Advanced Clinical, Deerfield, IL
Pages: 5 Size: 434 Kb 

Northeast SAS Users Group 2011

tweet!  A Validation Macro to Check Compliance of CDISC SDTM Data
  Hany Aboutaleb, Biogen Idec
Keywords: macro
Pages: 13 Size: 375 Kb 
tweet!  Automating SDTM File Creation: Metadata Files Speeding the Process
  Daphne E. Ewing, Auxilium Pharmaceuticals Inc.
Pages: 7 Size: 100 Kb 
tweet!  Validating CDISC Compliant Data and Creating Define.xml Made Easy
  Sandeep Purwar, Bodhi Global Solutions
Keywords: xml
Pages: 5 Size: 685 Kb 
tweet!  A Fast Programming Channel from DDT to Datasets in Pharmaceutical Industries
  Jianfeng Wang, Sanofi Pasteur; Linghua Zhou, Sanofi Pasteur
Pages: 7 Size: 152 Kb 
tweet!  Generating Define.xml
  Sandeep Kottam, Ockham; Uma Sarath Annapareddy, INDEPENDENT CONSULTANT; Sree Lakshmi K Tripuraneni, PURDUE PHARMA
Keywords: xml
Pages: 20 Size: 836 Kb 

Pharmaceutical SAS Users Group 2011

tweet!  An Excel Framework to Convert Clinical Data to CDISC SDTM Leveraging SAS Technology
  Sophie McCallum, Clinovo, Sunnyvale CA; Stephen Chan, Clinovo, Sunnyvale, CA
Keywords: CDISC, Microsoft Excel, Regulatory Submissions
Pages: 12 Size: 1217 Kb 
Best Paper
tweet!  Creating a define.xml file for ADaM and SDTM
  John H. Adams, Boehringer Ingelheim Pharmaceutical, Inc., Ridgefield, CT
Keywords: Define XML ADaM SDTM schema stylesheet, CDISC
Pages: 18 Size: 796 Kb 
tweet!  A Cost-Effective SDTM Conversion for NDA Electronic Submission
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Scott Moseley, Vertex Pharmaceuticals, Cambridge, MA; Min Chen, Vertex Pharmaceuticals, Cambridge, MA
Keywords: CDISC, Clinical Trials, Macros, Microsoft Excel, Regulatory Submissions, XML
Pages: 12 Size: 505 Kb 
tweet!  Automating the Process of Preparing Data Definition Document for NDA Electronic Submission from Programming Specification in Word Format
  Min Chen, Vertex Pharmaceuticals, Cambridge, MA; Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Scott Moseley, Vertex Pharmaceuticals, Cambridge, MA
Keywords: CDISC, Clinical Trials, Macros, Microsoft Excel, Regulatory Submissions, XML
Pages: 12 Size: 288 Kb 
tweet!  Evolution of SDTMIG 3.1.1 to 3.1.2: A mapping specialist must reference on these changes
  Rachit Desai, eClinical Solutions, New London, CT; Anirudh Gautam, MaxisIT, Metuchen, NJ; Vikash Jain, eClinical Solutions, New London, CT
Keywords: CDISC SDTMIG 3.1.1 3.1.2 Data Management Reporting
Pages: 8 Size: 356 Kb 
tweet!  Methods of Building Traceability for ADaM Data
  Songhui Zhu, K & L Consultant Services, Fort Washington, PA; Lin Yan, Celgene Corp, Basking Ridge, NJ
Keywords: ADaM, ADQS, Traceability, CDISC
Pages: 9 Size: 103 Kb 
tweet!  Validating Controlled Terminology in SDTM Domains
  John R. Gerlach, SAS / CDISC Analyst; Hamilton, NJ
Keywords: Regulatory Submissions, OpenCDISC, CDISC, Controlled Terminology
Pages: 12 Size: 98 Kb 
tweet!  Resolving OpenCDISC Error Messages Using SAS®
  Virginia Redner, Merck & Company, Inc., Upper Gwynedd, PA; John R. Gerlach, SAS / CDISC Analyst; Hamilton, NJ
Keywords: OpenCDISC, CDISC, SQL, Validation
Pages: 10 Size: 112 Kb 
tweet!  A Special SDTM Domain RELREC and its Application
  Changhong Shi, Merck Sharpe & Dohme Corp., Rahway, NJ; Beilei Xu, Merck Sharpe & Dohme Corp., Rahway, NJ
Keywords: CDISC
Pages: 8 Size: 35 Kb 
tweet!  Basic Understanding on SE Domain for Beginners
  Gayatri Karkera, i3 Statprobe (Ingenix Pharmaceutical Services), Mumbai, India
Keywords: CDISC
Pages: 4 Size: 174 Kb 
tweet!  Efficiencies Realized in Building and Utilizing ADaM from SDTM
  Shirish Nalavade, eClinical Solutions, a Division of Eliassen Group, Mansfield, MA; Parag Shiralkar, eClinical Solutions, a Division of Eliassen Group, New London, CT
Keywords: CDISC,ADaM, SDTM
Pages: 5 Size: 51 Kb 
tweet!  CDISC Variable Mapping and Control Terminology Implementation Made Easy
  Balaji Ayyappan, Ockham Group, Cary, NC; Manohar Sure, Ockham Group, Cary, NC
Keywords: CDISC
Pages: 5 Size: 208 Kb 
tweet!  ADaM Standard Naming Conventions are Good to Have
  Christine Teng, Merck Sharp & Dohme Corp, Rahway, NJ
Keywords: CDISC, ADaM, ExcelXP, Naming Convention, Regular Expressions
Pages: 8 Size: 71 Kb 
Best Paper
tweet!  Trials and Tribulations of SDTM Trial Design
  Fred Wood, Octagon Research Solutions, Wayne, PA; Mary Lenzen, Octagon Research Solutions, Wayne, PA
Keywords: CDISC
Pages: 5 Size: 64 Kb 
tweet!  The Standard for the Exchange of Nonclinical Data (SEND): History and Basics
  Fred Wood, Octagon Research Solutions, Wayne, PA; Lou Ann Kramer, Eli Lilly and Company, Indianapolis, IN
Pages: 9 Size: 203 Kb 
tweet!  Validating define.xml: Tools, trials, and tribulations
  Sandra VanPelt Nguyen, i3 Statprobe
Keywords: CDISC, define.xml, validation, schema
Pages: 5 Size: 42 Kb 
tweet!  Making a List, Checking it Twice (Part 1): Techniques for Specifying and Validating Analysis Datasets
  Elizabeth Li, PharmaStat LLC, Newark, California; Linda Collins, PharmaStat LLC, Newark, California
Keywords: CDISC, ADaM, Macros, SAS® programming validation, analysis data specification
Pages: 8 Size: 72 Kb 
Best Paper
tweet!  A Regular Language: The Annotated Case Report Form
  Ryan Wilkins, PPD, Inc., Wilmington, NC; Joel Campbell, PPD, Inc., Wilmington, NC
Keywords: CDISC, DEFINE.XML, Annotated CRF, aCRF, Adobe Acrobat, xFDF, BNF, parse, SAS Regular Expression, regular language
Pages: 9 Size: 94 Kb 
tweet!  Challenges in Implementing ADaM datasets: Balancing the Analysis-Ready and Traceability Concepts
  Pushpa Saranadasa, Merck & Co., Inc.
Keywords: CDISC
Pages: 7 Size: 125 Kb 
tweet!  Find / Track / Check and Close, Using SAS to Streamline SDTM Validation Including the Hyperlinks
  David Tillery, Smith Hanley Consulting, Lake Mary, Florida USA; Qiang Zhai, Purdue Pharma L.P., Stamford, Connecticut USA; Lily Peng, Purdue Pharma L.P., Stamford, Connecticut USA
Keywords: CDISC
Pages: 5 Size: 48 Kb 
tweet!  Ensuring Consistent Data Mapping Across SDTM-based Studies – a Data Warehouse Approach
  Annie Guo, ICON Clinical Research, North Wales, PA
Keywords: SDTM Mapping Clinical Trial Annotations CRF, CDISC, warehouse
Pages: 12 Size: 437 Kb 
tweet!  Truncation, Variable Association, Controlled Terminology, and Some Other Pitfalls in the SDTM Mapping Process
  Na Li, XenoPort, Inc., Santa Clara, CA; Gary de Jesus, Infovision, Inc., Richardson, TX; Daniel Bonzo, XenoPort, Inc., Santa Clara, CA
Keywords: CDISC, SDTM, ADaM, pitfalls
Pages: 8 Size: 67 Kb 
tweet!  Good Versus Better SDTM -- Date and Time Variables
  Mario Widel, Roche Molecular Systems, Inc., Pleasanton, CA; Henry B. Winsor, WinsorWorks, Limited, San Mateo, CA
Keywords: CDISC, SDTM, Date and Timing Variables
Pages: 3 Size: 56 Kb 
tweet!  Producing Clinical Laboratory Shift Tables From ADaM Data
  Rao Bingi, Octagon Research Solutions, Wayne, PA
Keywords: lab shift table, shift table, SAS, ADaM, shift tables, proc freq, Rao Bingi, Bingi, proc sql, CDISC
Pages: 12 Size: 385 Kb 
tweet!  Creating SDTM Datasets from Legacy Data
  Fred Wood, Octagon Research Solutions, Wayne, PA
Keywords: CDISC
Pages: 6 Size: 122 Kb 
tweet!  From SAP to BDS: The Nuts and Bolts
  Nancy Brucken, i3 Statprobe, Ann Arbor, MI; Paul Slagle, United BioSource Corp., Ann Arbor, MI
Keywords: ADaM, CDISC, BDS, Basic Data Structure
Pages: 9 Size: 161 Kb    Download the workshop filesdownload (.zip, 7423 Kb)
tweet!  SDTM, ADaM and define.xml with OpenCDISC®
  Matt Becker, PharmaNet, Cary, NC; Angela Ringelberg, PharmaNet, Cary, NC
Keywords: CDISC, xml
Pages: 13 Size: 5002 Kb 
tweet!  Brave New World: How to Adapt to the CDISC Statistical Computing Environment
  Jeff Abolafia, Rho, Inc., Chapel Hill NC; Frank DiIorio, CodeCrafters, Inc., Philadelphia PA
Keywords: CDISC; ADaM; SDTM; DASH; ADaM model; SDTM model; metadata; workflow; standards; standards implementation; statistical computing
Pages: 11 Size: 259 Kb 
tweet!  Method to Derive Reproducible SDTM Relationship Datasets
  Suwen Li, Everest Research Services Inc., Markham, ON; Sai Ma, Everest Research Services Inc., Markham, ON; Regan Li, Everest Research Services Inc., Markham, ON; Bob Lan, Everest Research Services Inc., Markham, ON
Keywords: CDISC
Pages: 9 Size: 181 Kb 
tweet!  Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You're Sorry When Creating SDTM Domains
  Janet Stuelpner, SAS Institute, Inc.; Jack Shostak, Duke Clinical Research Institute
Keywords: CDISC
Pages: 12 Size: 1764 Kb 
tweet!  Using the SAS® Clinical Standards Toolkit for define.xml creation
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: define.xml, CDISC, SDTM, SAS
Pages: 20 Size: 706 Kb    Download the presentationdownload (.pdf, 1721 Kb)
tweet!  New Tips and Tricks for Creating a Harmonized, Report-Friendly SDTM and ADaM Lab Data for a Clinical Study Report
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Min Chen, Vertex Pharmaceuticals, Cambridge, MA; Scott Moseley, Vertex Pharmaceuticals, Cambridge, MA
Keywords: LB SDTM, ADLB ADaM, CDISC compliant, Regulatory Submissions
Pages: 12 Size: 109 Kb 
Best Paper
tweet!  Using the ADaM Basic Data Structure for Survival Analysis
  Nancy Brucken, i3 Statprobe, Ann Arbor, MI; Sandra Minjoe, Octagon Research, Wayne, PA; Mario Widel, Roche Molecular Systems, Pleasanton, CA
Keywords: ADaM, BDS, survival analysis, TTE, time to event, CDISC, basic data structure
Pages: 5 Size: 48 Kb 

SAS Global Forum 2011

tweet!  Driving Clinical Safety Reviews with Data Standards
  Geoffrey A. Mann
Keywords: clinical
Pages: 7 Size: 422 Kb 
tweet!  State of the Union: The Crossroads of CDISC Standards and SAS' Supporting Role
  Michael Molter, Chris Decker
Pages: 14 Size: 430 Kb 
tweet!  Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You're Sorry When Creating SDTM Domains
  Janet Stuelpner, Jack Shostak
Keywords: clinical
Pages: 12 Size: 908 Kb 
tweet!  How to Build ADaM Basic Data Structure from Mock Up Table
  Kevin Lee
Pages: 4 Size: 77 Kb 
tweet!  Using SAS® to Incorporate the SDTM for a Study Funded by the NIH
  Fenghsiu Su, Bradford Jackson, Kaming Lo, Sumihiro Suzuki, Karan Singh, David Coultas
Pages: 8 Size: 100 Kb 
tweet!  What CDISC Means to SAS® Programmers
  Kevin Lee
Pages: 3 Size: 53 Kb 

Northeast SAS Users Group 2010

tweet!  Outsourced Data Integration Project with CDISC SDTM and ADaM Deliverables
  Margaret M. Coughlin, Merck & Co., Inc.; Christine Teng, Merck Research Laboratories
Pages: 11 Size: 187 Kb 
tweet!  Automating SDTM File Creation: Metadata Files Speeding the Process
  Daphne Ewing, Auxilium Pharmaceuticals, Inc.
Keywords: sponsor=AUXILIUM
Pages: 7 Size: 87 Kb 
tweet!  SAS and open source tools for CDISC SDTM compliance checks for regulatory submissions
  Sandeep Kottam, Eisai Pharmaceuticals; Peter Loonan, Smith Hanley Consulting; Sree Lakshmi Kalyani Tripuraneni, Contractor at Purdue Pharma
Pages: 4 Size: 326 Kb 
tweet!  The 5 Biggest Challenges of ADaM
  Terek Peterson, Octagon Research Solutions; David C. Izard, Shire
Pages: 11 Size: 130 Kb 
tweet!  Date Conversions in SDTM and ADaM Datasets
  Lily Zhang, Merck Sharp & Dohme Corp.; Lili Chen, Merck & Co.; Huei-Ling Chen, Merck & Co., Inc.
Pages: 8 Size: 68 Kb 
tweet!  The Past, Present, and Future of Clinical Data Standards
  Chris Decker, d-Wise Technologies
Keywords: clinical
Pages: 10 Size: 1366 Kb 
tweet!  Applying Metadata Attributes in Analysis Data Sets Using Macro Variables and Proc SQL in SAS®
  Rita Tsang, Averion International Corporation
Keywords: SQL, macro
Pages: 7 Size: 48 Kb 

Western Users of SAS Software 2010

tweet!  Creating a Patient Profile using CDISC SDTM
  Marc Desgrousilliers
Pages: 5 Size: 171 Kb 
tweet!  An Excel Framework to Convert Clinical Data to CDISC SDTM Leveraging SAS® Technology
  Ale Gicqueau
Pages: 12 Size: 1233 Kb 

Pharmaceutical Users Software Exchange 2010

tweet!  AstraZENeca and the ART of metadata maintenance
  Paul Frost, AstraZeneca
Keywords: CDISC INHERITANCE MAPPING METADATA SAS
Pages: 11 Size: 1000 Kb    Download the presentationdownload (.pdf, 5668 Kb)
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)
tweet!  Generate ATTRIB and FORMAT statements from the SAP
  Shafi Chowdhury, Shafi Consultancy Ltd
Keywords: ATTRIB, FORMATS, CDISC standard
Pages: 7 Size: 63 Kb    Download the presentationdownload (.ppt, 203 Kb)
Best Presentation
tweet!  Converting Data to CDISC Models: Research Project on Metadata Extraction, Exploration and Pooling
  Ronald Steinhau, Entimo AG; Dimitri Kutsenko, Entimo AG
Keywords: CDISC
Pages: 4 Size: 89 Kb    Download the presentationdownload (.ppt, 3583 Kb)
Driving value through Standardization - Industry Challenges and Best Practices
  Henry Levy, Accenture
  Download the presentationdownload (.ppt, 661 Kb)
tweet!  How can we do things better: A SAS Java Library Proposal and other stories
  Michael Auld, Michael Auld Consulting
Pages: 4 Size: 350 Kb 
tweet!  BeST- BIOEQUIVALENCE STUDY TEMPLATE
  Pekka Heikkila, StatFinn
Keywords: pharmacokinetics, PK, bioequivalence, ODS, RTF, CDISC, SDTM, ISO 8601, SAS
Pages: 9 Size: 1500 Kb    Download the presentationdownload (.ppt, 16178 Kb)
Best Presentation
tweet!  Introduction to SAS® Clinical Standards Toolkit
  Andreas Mangold, HMS Analytical Software GmbH; Nicole Wachter, HMS Analytical Software GmbH
Keywords: clinical
Pages: 16 Size: 725 Kb    Download the presentationdownload (.ppt, 1497 Kb)

SouthEast SAS Users Group 2010

tweet!  Tips and Tricks Of Efficient SAS® Programming for SDTM Data
  Eric Qi; Fikret Karahoda
Pages: 6 Size: 45 Kb 
tweet!  A Taste of ADaM
  Beilei Xu; Changhong Shi
Pages: 9 Size: 79 Kb 

Pharmaceutical SAS Users Group 2010

tweet!  Operational Uses of Patient Profiles ... Even in an eCTD and SDTM World
  Terek Peterson, Octagon Research Solutions; Sanjiv Ramalingam, Octagon Research Solutions
Keywords: Patient Profiles,eCTD,SDTM, CDISC
Pages: 8 Size: 309 Kb 
tweet!  How to validate SDTM SUPPQUAL data sets
  Kevin Lee, Covance
Keywords: validate , SDTM ,SUPPQUAL, CDISC
Pages: 4 Size: 104 Kb 
tweet!  ADaM Dataset Checking Toolkit
  Huei-Ling Chen, Merck & Co. Inc.
Keywords: ADaM . Checking, Toolkit, CDISC
Pages: 9 Size: 50 Kb 
tweet!  Applying ADaM Principals in Developing a Response Analysis Dataset
  Mei Dey,Merck & Co.;Lisa Pyle, Merck & Co.
Keywords: CDISC, ADaM, Principals, Response Analysis
Pages: 8 Size: 90 Kb 
Best Paper
tweet!  The CDISC/FDA Integrated Data Pilot: A Final Summary of Findings, Reviewer Feedback, and Recommendations Implementing CDISC Standards Within and Across Studies
  Chris Decker, d-Wise Technologies
Keywords: CDISC, FDA, SDTM, ADaM, Standards, Integration
Pages: 20 Size: 393 Kb 
tweet!  Help! The EX Domain is Now an Analysis Dataset! What Do I Do?!?
  David Izard, Octagon Research Solutions
Keywords: CDISC,EX Domain,Analysis Dataset
Pages: 4 Size: 99 Kb 
tweet!  How do we build ADaM from SDTM? A real case analysis
  Jianhua (Daniel) Huang, Forest Laboratories Inc
Keywords: ADaM ,SDTM, CDISC
Pages: 12 Size: 122 Kb 
tweet!  Automating the Process of Creating the Contents of Data Definition Document
  David Wang, Sanofi-aventis;Greg Ridge, Sanofi-aventis
Keywords: Define document, define.xml, define.pdf, SDTM, ADS, automate
Pages: 10 Size: 254 Kb 
tweet!  The SE Domain as Treatment Data Store: Using the SDTM Subject Elements (SE) domain to drive analyzing treatment
  Jeremy Gratt, Modular Informatics
Keywords: CDISC, SDTM, SE, Treatment
Pages: 10 Size: 537 Kb 
tweet!  Creating SV and SE first
  Henry Winsor, WinsorWorks,Limited;Mario Widel, Genentech
Keywords: SV,SE,data
Pages: 7 Size: 156 Kb 
tweet!  The 5 Biggest Challenges of ADaM
  Terek Peterson, Octagon Research Solutions;David Izard, Octagon Research Solutions
Keywords: ADaM,CDISC
Pages: 11 Size: 268 Kb 
tweet!  Quality in a World of Standards with Differences
  Sandra VanPelt Nguyen, i3 Statprobe
Keywords: CDISC, SDTM, WebSDM, quality
Pages: 9 Size: 48 Kb 
tweet!  Achieving Efficiencies in CDISC SDTM Data Conversions and Its Challenges- Case Study
  Ilango Ramanujam, TAke Solutions Inc
Keywords: CDISC, SDTM conversion
Pages: 6 Size: 224 Kb 
tweet!  In-Depth Review of Validation Tools to Check Compliance of SDTM-Ready Clinical Datasets
  Bhavin Busa, Cubist Pharmaceuticals, Inc.;Kim Lindfield, Cubist Pharmaceuticals, Inc.
Keywords: OpenCDISC, SAS-CST, SDTM Validation Tools
Pages: 8 Size: 148 Kb    Download the presentationdownload (.pdf, 1196 Kb)
Best Paper
tweet!  Accessing the metadata from the define.xml using XSLT transformations
  Lex Jansen, Octagon Research Solutions, Inc.
Keywords: define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
Pages: 24 Size: 986 Kb    Download the presentationdownload (.pdf, 1322 Kb)
tweet!  Thanks CDISC “Free Utilities”
  Robert Agostinelli, Sepracor
Keywords: CDISC, OpenCDISC, SAS
Pages: 5 Size: 171 Kb 
tweet!  Checking for SDTM Compliance: The Need for Human Involvement
  Fred Wood, Octagon Research Solutions
Keywords: SDTM Compliance,CDISC
Pages: 8 Size: 83 Kb 
tweet!  Updating SDTM Metadata Excel File (Define.xls) with SAS
  Lin Yan, Merck & Co., Inc
Keywords: SDTM, Metadata, Define,Excel, CDISC
Pages: 6 Size: 75 Kb 
tweet!  SDTM Attribute Checking Tool
  Ellen Xiao, Merck
Keywords: SDTM ,Checking Tool, CDISC
Pages: 6 Size: 176 Kb 
tweet!  Editing SAS® Metadata Automated From CSV Files Using XML String in SAS® Data Integration Studio
  Annie Guo, ICON Clinical Research
Keywords: 'Proc Metadata, xml
Pages: 11 Size: 157 Kb 
tweet!  From SAP to ADaM: The Nuts and Bolts
  Nancy Brucken, i3 Statprobe; Paul Slagle, United Biosource Corp.
Keywords: SAP ,ADaM, CDISC
Pages: 9 Size: 80 Kb 
tweet!  Accessing and using the metadata from the define.xml
  Lex Jansen, Octagon Research Solutions, Inc.
Keywords: define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
Pages: 22 Size: 1004 Kb    Download the presentationdownload (.pdf, 1638 Kb)
tweet!  Insights into ADaM
  Matthew Becker, PharmaNet
Keywords: ADaM, CDISC
Pages: 9 Size: 483 Kb 
tweet!  CDASH Standards for Medical Device Trials: CRF Analysis
  Parag Shiralkar, Eliassen Group;Jennie Tedrow, Boston Scientific;Kit Howard, Kestrel Consultants;Laura Fazio, DePuy Orthopaedics
Keywords: CDASH ,Standards, Medical Device Trials, CRF Analysis
Pages: 8 Size: 132 Kb 
tweet!  Medical Device and Diagnostic Industry 101
  Carey Smoak, Roche Molecular Systems, Inc.
Keywords: Device, Diagnostic, Approval, CDISC
Pages: 5 Size: 32 Kb 
tweet!  Exploring SAS® PROC CDISC Model ODM and Its Limitations
  Elena Valkanova, BioStat International, Inc.;Irene Droll, XClinical GmbH
Keywords: PROC CDISC Model ODM
Pages: 9 Size: 134 Kb 
tweet!  Case Study: Handling Non-English Clinical Trials Data in SDTM Conversions for US-FDA Submissions
  Ramanan Bathala, TAKE Solutions Limited
Keywords: Non-English Clinical Trials Data, SDTM Conversions, US-FDA Submissions, CDISC
Pages: 5 Size: 124 Kb 
tweet!  Using the SAS Clinical Standards Toolkit to Validate CDISC SDTM Data
  Gene Lightfoot, SAS Institute Inc.
Keywords: CDISC
Pages: 33 Size: 1523 Kb 
tweet!  Managing Clinical Data Standards: An Introduction to SAS® Clinical Data Integration
  Michael Kilhullen, SAS Institute Inc.
Keywords: Clinical Data Standards,Clinical Data Integration
Pages: 10 Size: 683 Kb 

SAS Global Forum 2010

tweet!  Using PROC CONTENTS Output to Perform Quality Control Checks on SDTM Data Sets
  Jennifer M. Srivastava
Pages: 6 Size: 53 Kb 
tweet!  Understanding the define.xml File and Converting It to a Relational Database
  Lex Jansen
Keywords: define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
Pages: 20 Size: 1101 Kb    Download the workshop filesdownload (.zip, 2021 Kb)
tweet!  Managing Clinical Data Standards: An Introduction to SAS® Clinical Data Integration
  Michael Kilhullen
Keywords: clinical
Pages: 10 Size: 715 Kb 
tweet!  Automating SDTM File Creation: Speeding Up the Process with Metadata Files
  Daphne Ewing
Pages: 7 Size: 91 Kb 
tweet!  Dealing with Lab Data: Stacking the Deck in Your Favor
  Jennifer K. Fulton
Pages: 9 Size: 211 Kb 
tweet!  The Past, Present, and Future of Clinical Data Standards
  Chris Decker
Keywords: clinical
Pages: 10 Size: 600 Kb 
tweet!  SDTM Attribute-Checking Tool
  Ellen Xiao
Pages: 6 Size: 172 Kb 

SouthEast SAS Users Group 2009

tweet!  A SAS® Macro to Automate the Process of Define.xml
  Wenyu Hu; Liping Zhang
Keywords: xml, macro
Pages: 5 Size: 61 Kb 
tweet!  Exploring SAS® PROC CDISC Model=ODM and its Undocumented Parameters
  Elena Valkanova; Irene Droll
Pages: 7 Size: 99 Kb 
tweet!  Mapping Nested e-CRF Data into SDTM Domains
  Venkata Sekhar Bhamidipati; Kristi L. Garner
Pages: 5 Size: 170 Kb 

Pharmaceutical Users Software Exchange 2009

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
Keywords: RELREC SUPPQUAL SDTM, CDISC, macro, xml
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)
tweet!  After a new CDISC SDTM version, how to update and manage ADS/SDS DEFINE files at company team level
  Nathalie Moro, Sanofi-Aventis
Keywords: CDISC
Pages: 5 Size: 201 Kb 

Northeast SAS Users Group 2009

tweet!  Sol LeWitt and the CDISC Initiative: A Comparative Essay
  Karin LaPann, ViroPharma Inc.
Pages: 10 Size: 186 Kb 
tweet!  A Proposed SDTM Implementation of Response Data for Solid Tumor Trials in Oncology
  Mei Dey, Merck & Co., Inc.; Elisabeth Pyle, Merck & Co., Inc.
Pages: 18 Size: 423 Kb 
tweet!  Successful Lab Result Conversion for LAB Analysis Data with Minimum Effort
  Pushpa Saranadasa, MERCK Inc.
Pages: 8 Size: 98 Kb 
tweet!  A Taste of SDTM in Real Time
  Changhong Shi, Merck & Co.; Beilei Xu, Merck & Co., Inc.
Pages: 6 Size: 90 Kb 
tweet!  A Complete Derivation of Duration and Display in ISO 8601 Using SAS Program
  Joyce Gui, JPG Advanced Techology; Helen Wang, Merck & Co., Inc.; Sandy Wang, Rutgers, The State University of New Jersey
Pages: 8 Size: 91 Kb 
tweet!  Supporting CDISC Standards in Base SAS® Using the SAS® Clinical Standards Toolkit
  Peter Villiers, SAS Institute
Keywords: clinical
Pages: 13 Size: 608 Kb 

Western Users of SAS Software 2009

tweet!  BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users
  Clinton Brownley, independent statistical consultant
Pages: 6 Size: 180 Kb 
tweet!  The Second CDISC Pilot Project: A Metastandard for Integrating Databases
  Gregory Steffens, Eli Lilly & Co.; Ian Fleming, Genentech, Inc.
Pages: 5 Size: 70 Kb 
tweet!  CDISC Implementation on a Rheumatoid Arthritis Project Partnership
  Patricia Gerend, Genentech, Inc.; Chris Price, Roche Products Limited; Olivier LeConte, Roche Products Limited; Michelle Zhang, Genentech, Inc.
Pages: 9 Size: 87 Kb 
tweet!  How a SAS/IntrNet tool was created at the FDA for the detection of potential drug-induced liver injury using data with CDISC standard
  Ted Guo, FDA; John Senior, FDA; Kate Gelperin, FDA
Pages: 17 Size: 481 Kb 
tweet!  CDISC for the Medical Device and Diagnostic Industry: An Update
  Carey Smoak, Roche Molecular Systems, Inc.
Keywords: CDISC, SDTM, CDASH, Devices, Diagnostics
Pages: 3 Size: 54 Kb 
tweet!  The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
  Fred Wood, Octagon Research Solutions, Inc.
Keywords: SAS Drug Development, Report Management, User Interface, Application Development, Regulatory Compliance, Web-enabled
Pages: 9 Size: 146 Kb 

Pharmaceutical SAS Users Group 2009

tweet!  Converting CDISC Controlled Terminology to SAS Formats
  Sandeep Juneja
Keywords: CDISC
Pages: 5 Size: 198 Kb 
tweet!  Clinical Data Acquisition Standards Harmonization (CDASH) Standard Version 1.0
  Kim Truett
Keywords: CDISC, CDASH
Pages: 1 Size: 30 Kb 
tweet!  Using CDISC Lab Terminology and Determining Standard Units
  Mat Davis
Keywords: CDISC
Pages: 7 Size: 92 Kb 
tweet!  Understanding the define.xml and converting it to a relational database
  Lex Jansen
Keywords: define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
Pages: 17 Size: 1578 Kb    Download the codedownload (.zip, 2655 Kb)
tweet!  The Second CDISC Pilot - A Metastandard for Integrating Databases
  Gregory Steffens
Keywords: CDISC
Pages: 4 Size: 42 Kb 
Best Paper
tweet!  A Practical Introduction to Clinical Data Acquisition Standards Harmonization (CDASH)
  Jennifer Price
Keywords: CDASH SDTM CDISC CRF
Pages: 5 Size: 70 Kb 
tweet!  Nice SUPPQUAL Variables to Have
  Beilei Xu
Pages: 5 Size: 68 Kb 
tweet!  An Implementation of CDISC SDTM and ADaM Standards at MedImmune
  Alan Meier
Keywords: CDISC
Pages: 11 Size: 323 Kb 
tweet!  Creating the Case Report Tabulation (CRT) for an NDA submission at the absolute last moment - NOT
  Steve Wong
Keywords: define.pdf; CDISC; CRT; Case Report Tabulation; eCTD; Submission; MetaData; NDA; New Drug Application; Documentaion; BLA; Biologics License Application
Pages: 9 Size: 217 Kb 
tweet!  Implementing CDISC When You Already Have Standards
  Sandra Minjoe
Keywords: CDISC, standard, adopt, implement, convert, strategy, decision, resource, FDA
Pages: 10 Size: 187 Kb 
tweet!  Converting the define.xml to a relational database to enable printing and validation
  Lex Jansen
Keywords: define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
Pages: 18 Size: 1615 Kb    Download the presentationdownload (.pdf, 2645 Kb)
tweet!  Data Conversion to SDTM - What Sponsors Can Do to Facilitate the Process
  Fred Wood
Keywords: CDISC
Pages: 6 Size: 146 Kb 
Using SAS® Clinical Data Integration Server to Implement and Manage CDISC Standards
  Michael Kilhullen
Keywords: CDISC
tweet!  Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit
  Peter Villiers
Keywords: CDISC
Pages: 13 Size: 595 Kb 

SAS Global Forum 2009

tweet!  HL7, CDISC, and the FDA—Moving on Down the Path to Data Standards
  Steve Wilson
Pages: 1 Size: 17 Kb 
tweet!  Supporting CDISC Standards in Base SAS® Using the SAS® Clinical Standards Toolkit
  Peter Villiers
Keywords: clinical
Pages: 13 Size: 588 Kb 
tweet!  Implementing CDISC When You Already Have Standards: A Case Study
  Sandra Minjoe
Pages: 10 Size: 221 Kb 
tweet!  A SAS® Programmer's Guide to Generating Define.xml
  Michael Molter
Keywords: xml
Pages: 24 Size: 172 Kb 
tweet!  Using SAS® Clinical Data Integration Server to Implement and Manage CDISC Standards
  Michael Kilhullen
Keywords: clinical
Pages: 7 Size: 899 Kb 
tweet!  The Second CDISC Pilot Project: Standards for Integrating Databases
  Ian Fleming, Gregory Steffens
Pages: 4 Size: 48 Kb 
tweet!  Backpacking Your Way through CDISC: A Budget-Minded Guide to Basic Concepts and Implementation
  Rachel Brown, Jennifer K. Fulton
Pages: 7 Size: 118 Kb 
tweet!  Mapping CDISC Metadata Attributes: Using DATA _NULL_ and PROC DATASETS in SAS®
  Rita Tsang
Pages: 8 Size: 460 Kb 

SouthEast SAS Users Group 2008

tweet!  A Programming Methodology for Creating CDISC Domain Data Sets
  John R. Gerlach
Pages: 1 Size: 819 Kb 
tweet!  An Approach for Deriving a Timing Variable in SDTM Standards
  Shaoan Yu; Joyce Gui
Pages: 9 Size: 874 Kb 

Pharmaceutical Users Software Exchange 2008

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 
tweet!  Practical application of SAS® Clinical Data Integration Server for conversion to SDTM data
  Mark Lambrecht, SAS Institute; Peter Van Reusel, Business & Decision Life Sciences
Keywords: SAS Clinical DI SDTM CDISC conversion clinical
Pages: 9 Size: 418 Kb 

Northeast SAS Users Group 2008

tweet!  An Approach to CDISC SDTM Implementation for Clinical Trials Data
  William Chen, Merck & Co., Inc.; Margaret M. Coughlin, Merck & Co., Inc.
Keywords: clinical
Pages: 5 Size: 59 Kb 
tweet!  Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed)
  Lex Jansen, Octagon Research Solutions, Inc.
Keywords: define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
Pages: 20 Size: 1260 Kb    Download the presentationdownload (.pdf, 2429 Kb)
tweet!  An Animated Guide: the Logical cascade when entering Orres data
  Russ M. Lavery, Self
Pages: 11 Size: 203 Kb 

Pharmaceutical SAS Users Group 2008

tweet!  Cost-Effective Solution to Automating the Creation of CDISC define.xml: Using SAS Data _Null_ with Relational Data Model via SAS/AF Application
  Annie Guo, ICON Clinical Research
Keywords: CDISC, xml, af
Pages: 12 Size: 534 Kb 
tweet!  A Toolkit for CDISC Implementation
  Robert Stemplinger, ICON Clinical Research
Keywords: CDISC
Pages: 6 Size: 30 Kb 
tweet!  SDTM, Plus or Minus
  Barry Cohen, Octagon Research Solutions, Inc.
Keywords: CDISC
Pages: 6 Size: 129 Kb 
tweet!  A SAS based solution for define.xml
  Monika Kawohl, Accovion
Keywords: define.xml, CDISC, electronic submissions
Pages: 18 Size: 362 Kb 
tweet!  Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry
  Carey Smoak, Roche Molecular Systems, Inc.
Keywords: CDISC, Device, Diagnostic
Pages: 2 Size: 53 Kb 
Best Paper
tweet!  Experiences Submitting CDISC SDTM and JANUS Compliant Datasets
  Carol R Vaughn, Sanofi-Aventis; Greg Ridge, Sanofi-Aventis
Keywords: Janus, WebSDM, rule violations, SDTM, CDISC
Pages: 10 Size: 61 Kb 
tweet!  Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed)
  Lex Jansen, TAKE Solutions
Keywords: define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
Pages: 20 Size: 1266 Kb 
tweet!  Case Study: Analysis and Metrics of End-to-End Legacy Data Conversions into SDTM, ADaM, and Define.xml
  Robert Stemplinger, ICON Clinical Research
Keywords: CDISC, xml
Pages: 5 Size: 49 Kb 
Best Paper
tweet!  Validating CDISC SDTM-Compliant Submission-Ready Clinical Datasets with an In-House SAS® Macro-Based Solution
  Bhavin A. Busa, Cubist Pharmaceuticals Inc.; Sheila Vince, Cubist Pharmaceuticals Inc.; Jameelah Aziz, Cubist Pharmaceuticals Inc.
Keywords: CDISC, macro
Pages: 12 Size: 358 Kb 
tweet!  Managing The Change And Growth Of A Metadata-Based System
  Frank DiIorio, CodeCrafters, Inc.
Keywords: metadata; CDISC; FDA submissions; project management; metadata tools; user interface
Pages: 11 Size: 472 Kb 
tweet!  The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
  Fred Wood, Octagon Research Solutions
Keywords: CDISC
Pages: 8 Size: 213 Kb 
tweet!  A regulatory submission “DEFINE”d: The who, where, and what.
  Robert Diseker, PPDI
Pages: 9 Size: 436 Kb 
tweet!  SAS, CDISC and Clinical Data Integration
  Peter Villiers, SAS Institute Inc.
Keywords: CDISC
Pages: 27 Size: 4697 Kb 

SAS Global Forum 2008

tweet!  Using Excel XP to Display SDTM Metadata and More
  Christine Teng; Shaoan Yu
Keywords: ExcelXP, Tagset, SAS Dictionary, PROC SQL
Pages: 8 Size: 182 Kb 
tweet!  The Evolution of SAS® in Life Sciences Research and Development
  David Handelsman
Keywords: pharmaceutical biotechnology CDISC
Pages: 10 Size: 422 Kb 
tweet!  CDISC: Pains and Pitfalls of Data Set Creation
  Steven L. Michaelson; Janet Stuelpner
Keywords: CDISC SDTM
Pages: 5 Size: 35 Kb 
tweet!  Practical Methods for Creating CDISC SDTM Data Sets from Existing Data
  Robert W. Graebner
Pages: 11 Size: 892 Kb 

Northeast SAS Users Group 2007

tweet!  Benefits of Using Excel File in CDISC SDTM Data Mapping
  Hong Wang, Clinforce LLC
Pages: 8 Size: 615 Kb 
tweet!  Relationships Between ORRES and Other CDISC Variables (CDISC Variable Relationships Part 1 of 3)
  Susan Fehrer, BioClin; Russ Lavery, Independent Consultant
Keywords: CDISC relationship ORRES STRESC STRESN STRESU
Pages: 9 Size: 570 Kb 
tweet!  Relationships Between CDISC Variables Concerning Day and Date (CDISC Variable Relationships Part 2 of 3)
  Susan Fehrer, BioClin; Russ Lavery, Independent Consultant
Pages: 10 Size: 388 Kb 
tweet!  Relationships Between CDISC Variables Linking Domains (relrec) (CDISC Variable Relationships Part 3 of 3)
  Susan Fehrer, BioClin; Russ Lavery, Independent Consultant
Keywords: RELREC CDISC Variable Relationships
Pages: 12 Size: 358 Kb 

Pharmaceutical Users Software Exchange 2007

tweet!  MAKS: A validated SAS Macro Library for Clinical Data in the CDISC SDTM Structure
  Rolf Meinert, Platform for Medical Research Networks (www.tmf-ev.de), KKS-Mainz, Mainz; Katrin Bhalla-Muller, Platform for Medical Research Networks (www.tmf-ev.de), KKS-Mainz, Mainz; Jessica Wisniewski, Platform for Medical Research Networks (www.tmf-ev.de), KKS-Mainz, Mainz; Daniel Wachtlin, Platform for Medical Research Networks (www.tmf-ev.de), KKS-Mainz, Mainz
Keywords: CDISC, macro, clinical
Pages: 3 Size: 28 Kb 
tweet!  Standardizing FDA Data to Improve Success in Pediatric Drug Development
  Julie Maddox, SAS Institute, Cary, NC, USA; Chris Decker, SAS Institute, Cary, NC, USA
Keywords: CDISC,SDTM, FDA
Pages: 12 Size: 209 Kb 
Best Presentation
tweet!  A SAS based solution for define.xml
  Monika Kawohl, Accovion GmbH, Marburg, Germany
Keywords: define.xml, CDISC, electronic submissions
Pages: 18 Size: 481 Kb 
tweet!  Relationships Among CDISC Variables Concerning Day and Date (CDISC Variable Relationships Part 2 of 3)
  Susan Fehrer, BioClin, Inc.; Russ Lavery
Keywords: CDISC
Pages: 10 Size: 216 Kb 
tweet!  Relationships Between CDISC Variables Linking Domains (RELREC) (Part 3 of 3)
  Susan Fehrer, BioClin, Inc.; Russ Lavery
Keywords: CDISC
Pages: 12 Size: 213 Kb 
tweet!  Creation of Submission and Analysis Data Sets by following the SDTM and ADAM requirements
  Yvane Boudraa, sanofi-aventis pharma, Antony, France
Keywords: CDISC
Pages: 4 Size: 118 Kb 
tweet!  MDMAP (Meta Data Management and Publishing) An application utilized in the management of clinical trial metadata
  Herve Guimard, Sanofi-Aventis, France; Eric Sorel, Sanofi-Aventis, France
Keywords: clinical
Pages: 5 Size: 257 Kb 
tweet!  A validated tool to create the Submission and Analysis Data Sets
  Claude Guyot, sanofi-aventis pharma, Chilly-Mazarin, France
Pages: 5 Size: 152 Kb 
tweet!  All roads lead to SDTM - which one shall we take?
  Ian Fisher, AstraZeneca, Alderley Park, UK; Meena Rahman, AstraZeneca, Alderley Park, UK; Donna Thompson, AstraZeneca, Alderley Park, UK
Keywords: CDISC
Pages: 9 Size: 58 Kb 
tweet!  Considerations for CDISC implementation
  Robert T. Stemplinger, ICON Clinical Research, Redwood City, CA; Jackie Lane, ICON Clinical Research, Redwood City, CA
Keywords: CDISC
Pages: 4 Size: 36 Kb 
tweet!  Relationships Among - -ORRES and Other CDISC Variables (Part 1 of 3)
  Susan Fehrer, BioClin, Inc.; Russ Lavery
Keywords: CDISC
Pages: 9 Size: 276 Kb 

Pharmaceutical SAS Users Group 2007

tweet!  A Conceptual Framework For Clinical Trials - Interoperability And Automation In A Web-based Environment
  John Gerlach, MaxisIT, Inc.; Maulik Shah, MaxisIT, Inc.
Keywords: Interoperability, CRT-DDS, XML, CDISC, SDTM, internet
Pages: 11 Size: 82 Kb 
tweet!  The Submission Data File System - Automating the Creation of CDISC SDTM and ADaM Datasets
  Marcus G Bloom, Amgen; David Edwards, Amgen
Keywords: SDF, CDISC, SDTM, ADaM, Software Development, SAS, Java, Oracle'; 'SDF, CDISC, SDTM, ADaM, Software Development, SAS, Java, Oracle
Pages: 15 Size: 3041 Kb 
Best Paper
tweet!  Customizing DI Studio to Generate CDISC Compliant SDTM Domains
  Tatyana Kovtun, Berlex Laboratories; John Markle, Berlex Labs; Chris Treglio, Berlex Laboratories
Keywords: DI Studio, Java plug-in, generic job module, CDISC
Pages: 12 Size: 374 Kb 
tweet!  Taking a Walk on the Wildside: Use of the PROC CDISC-SDTM 3.1 Format
  William C Csont, H.M. Proskin & Associates, Inc.
Keywords: PROC CDISC SDTM
Pages: 6 Size: 48 Kb 
tweet!  CDISC: Pains and Pitfalls to Dataset Creation
  Janet Stuelpner, Left Hand Computing; Steven Michaelson, Simulstat, Inc.
Keywords: CDISC, macros
Pages: 5 Size: 56 Kb 
tweet!  Considerations for CDISC Implementation
  Robert T Stemplinger, ICON Clinical Research; Jackie Lane, ICON Clinical Research
Keywords: CDISC ODM SDTM ADAM PROC CDISC XML
Pages: 4 Size: 50 Kb 
tweet!  SDTM, Plus or Minus
  Barry R Cohen, Octagon Research Solutions, Inc.
Keywords: SDTM, CDISC, SDTM-plus, SDTM-minus, Data Standards
Pages: 6 Size: 143 Kb 
tweet!  A Harmonized, Report-Friendly SDTM and ADaM Data Flow
  Aileen L Yam, sanofi-aventis
Keywords: CDISC, SDTM SDS, ADaM, data flow, standards, report-friendly, domain
Pages: 4 Size: 78 Kb 
tweet!  From CRF Data to DEFINE.XML: Going “End to End” with Metadata
  Frank C DiIorio, CodeCrafters, Inc.; Jeffrey M Abolafia, Rho, Inc.
Keywords: Metadata, NDA submissions, clinical trials, DEFINE.XML, CDISC, SDTM
Pages: 20 Size: 719 Kb 
tweet!  Strategies and Practical Considerations for Creating CDISC SDTM Domain Data Sets from Existing CDM Data Sets
  Robert W Graebner, GRAE Tech
Keywords: CDISC,SDTM,Metadata Mapping,Proc CDISC
Pages: 12 Size: 486 Kb 
tweet!  Managing the CRO Relationship to Effectively Request and Receive CDISC STDM and ADaM Deliverables
  David C Izard, Shire Pharmaceuticals; Terek J Peterson, Shire Pharmaceuticals; Kenneth Eng, Shire Pharmaceuticals
Keywords: FDA, CDISC, eCTD, ADaM, SDTM, CRO, Vendor Management
Pages: 8 Size: 527 Kb 
Best Paper
tweet!  Evolution and Implementation of CDISC Study Data Tabulation Model (SDTM)
  Frederick Wood, Octagon Research Solutions, Inc.; Thomas Guinter, TAKE Solutions, Inc.
Keywords: CDISC, SDTM, data standards, case report tabulation
Pages: 7 Size: 172 Kb    Download the presentationdownload (.pdf, 421 Kb)
tweet!  CDISC for the Medical Device and Diagnostic Industry
  Carey G Smoak, Roche Molecular Systems
Keywords: CDISC, Device, Diagnostic
Pages: 4 Size: 98 Kb 
tweet!  CDISC Implementation Step by Step: A Real World Example
  Sy J Truong, Meta-Xceed, Inc.; Patricia Gerend, Genentech, Inc.
Keywords: CDISC, SDTM 3.1, Data Standards, Data Transformation
Pages: 19 Size: 738 Kb 
tweet!  Relationships Among Variables in CDISC Domains
  Susan M Fehrer, BioClin, Inc.
Keywords: CDISC, SDTM, DOMAIN, relationships
Pages: 9 Size: 317 Kb 
tweet!  Best Practices for Working with CDISC Metadata in the SAS® Data Integration Server
  Michael Kilhullen, SAS Institute, Cary, NC
Keywords: CDISC, Metadata, Data Integration Server, XML, Metadata Server
Pages: 10 Size: 174 Kb 
tweet!  Implementing CDISC Data Models in the SAS® Metadata Server
  Michael Kilhullen, SAS Institute, Cary, NC
Keywords: CDISC, Metadata Server, Data Integration Studio, SDTM
Pages: 7 Size: 391 Kb 
tweet!  The use of CDISC Standards in SAS from Data Capture to Reporting
  Andrew Fagan, SAS Institute, Cary, NC; John Leveille, d-Wise Consulting, Raleigh, NC
Keywords: CDISC, SDTM, SAS DI, SAS Drug Development
Pages: 21 Size: 1888 Kb 
tweet!  Developing Reporting and Analysis Methodologies
  Amy E Gillespie, Merck & Co., Inc.; Mary Varughese, Merck & Co., Inc
Keywords: CDISC, SDTM, ADaM, SAS Drug Development, analysis, reporting
Pages: 5 Size: 48 Kb 

SAS Global Forum 2007

tweet!  Extending SAS® Data Integration Studio with Java: Custom GUIs and SAS Server Interactions
  Christopher Treglio
Keywords: define.xml 'Workspace Server' 'Metadata Server' CDISC SDTM 'ETL Studio'
Pages: 15 Size: 482 Kb 
tweet!  Keynote Presentation: Standards for Clinical Research from Protocol Through Submission: CDISC Business Case and Progress Report
  Rebecca Kush
Keywords: CDISC, clinical
Pages: 1 Size: 17 Kb 
tweet!  SAS Response: Concepts and Thoughts for a CDISC /FDA Pilot and Interfacing with HL7 RCRIM Projects
  Edward D. Helton
Pages: 1 Size: 17 Kb 
tweet!  Customer Case Study: The Use of Metadata in the CDISC SDTM/ADaM Pilot Project
  Gregory C. Steffens
Keywords: FDA CDISC SDTM ADaM metadata
Pages: 1 Size: 17 Kb 
tweet!  Customer Case Study: Overview of the CDISC Pilot Project
  Greg Anglin
Pages: 1 Size: 16 Kb 
tweet!  Customer Case Study: Building a Clinical Trials Data Repository using the CDISC SDTM standards and ETL
  Musa Nsereko
Keywords: clinical
Pages: 1 Size: 16 Kb 
tweet!  What's New in the XML LIBNAME Engine
  Tony Friebel; Richard Foley
Keywords: CDISC, XBRL, WSDL, SOAP, EXPORT, Oracle9i, XQuery, xml
Pages: 1 Size: 16 Kb 

Pharmaceutical Users Software Exchange 2006

tweet!  Contours of a Drug Development Data Warehouse
  Paul Vervuren, NV Organon; Frank Dietvorst, PW Consulting
Keywords: data warehouse, drug development, clincial data, data model, CDISC, warehouse architecture
Pages: 8 Size: 870 Kb 
Best Presentation
tweet!  Submission Data File System (SDF)
  David Edwards, Amgen; Marcus Bloom, Amgen
Keywords: SDF, CDISC, SDTM, ADaM, Software Development, SAS, Java, Oracle
Pages: 6 Size: 662 Kb 
Best Presentation
tweet!  Converting Data to the SDTM Standard Using SAS Data Integration Studio
  Barry Cohen, Octagon Research Solutions, Inc.
Keywords: CDISC Standards, SDTM, Data Integration Studio, data conversion, data integration
Pages: 8 Size: 332 Kb 
tweet!  Using CDISC Models for the Analysis of Safety Data
  Susan Kenny, Inspire Pharmaceuticals, Inc.; Ed Helton, SAS Institute
Keywords: CDISC, SDTM, ADaM, safety analysis, analysis datasets
Pages: 10 Size: 321 Kb 
tweet!  The use of CDISC Standards in SAS from Data Capture to Reporting
  Andrew Fagan, SAS; John Leveille, d-wise
Keywords: CDISC
Pages: 21 Size: 2056 Kb 

SouthEast SAS Users Group 2006

tweet!  A Relational Understanding of SDTM Tables
  John R Gerlach; Glenn O'Brien
Keywords: CDISC; SDTM; SQL; Macro Language
Pages: 10 Size: 286 Kb 

Western Users of SAS Software 2006

tweet!  New CDISC Training Initiative
  Dana Rafiee, Destiny Corporation, Rocky Hill, CT
Pages: 2 Size: 25 Kb 
tweet!  Step by Step PROC CDISC and More
  Sy Truong, Meta?Xceed, Inc, Milpitas, CA
Keywords: PROC CDISC, SDTM, ODM, CDISC Implementation
Pages: 19 Size: 921 Kb 

Northeast SAS Users Group 2006

tweet!  Using SAS Data Integration Studio to Convert Clinical Trials Data to the CDISC SDTM Standard
  Barry Cohen, Octagon Research Solutions, Inc
Keywords: data integration, Data Integration Studio, CDISC, SDTM, data standards, clinical
Pages: 8 Size: 255 Kb 
tweet!  ISO 8601 - An International Standard for Date and Time Formats
  Shi-Tao Yeh, GlaxoSmithKline
Pages: 5 Size: 80 Kb 
tweet!  Using PROC CDISC
  Chauthi Nguyen, GlaxoSmithkline
Pages: 5 Size: 147 Kb 

Pharmaceutical SAS Users Group 2006

Best Paper
tweet!  Mapping Clinical Data to a Standard Structure: A Table Driven Approach
  Nancy Brucken, i3 Statprobe; Paul Slagle, i3 Statprobe
Keywords: standards, mapping, CDISC, integrated, table-driven
Pages: 7 Size: 41 Kb 
tweet!  MDMAP - An Innovative Application Used To Manage Clinical Trial Metadata
  Gregory S. Ridge, Sanofi-Aventis; Neeru Bhardwaj, Sanofi-Aventis
Keywords: eSUB, metadata, FDA, clinical trials, oracle, SAS
Pages: 9 Size: 262 Kb 
tweet!  Managing Clinical Trials Data using SAS® Software
  Martin J. Rosenberg, MAJARO InfoSystems, Inc.
Keywords: ClinAccess, SAS/SHARE, database, imaging, CDISC, clinical data management
Pages: 7 Size: 316 Kb 
tweet!  Cost Effective Ways to Generate Define.PDF & Define.XML
  Sy J. Truong, MXI, Meta-Xceed, Inc.
Keywords: Data Definition Documentation, DEFINE.PDF, DEFINE.XML, CDISC
Pages: 7 Size: 331 Kb 
Best Paper
tweet!  Evolution and Implementation of CDISC Study Data Tabulation Model (SDTM)
  Tom S. Guinter, Octagon Research Solutions, Inc.; Fred Wood, Procter & Gamble Pharmaceuticals
Keywords: SDTM, CDISC, NDA, Standards, CRT
Pages: 6 Size: 157 Kb 
tweet!  Using SAS ETL Studio to Convert Clinical Trials Data to the CDISC SDTM
  Barry R. Cohen, Octagon Research Solutions, Inc.
Keywords: ETL Studio, CDISC, SDTM, Data Conversion, Data Mapping
Pages: 10 Size: 89 Kb 
tweet!  CDISC Implementation, Real World Applications
  Sy J. Truong, MXI, Meta-Xceed, Inc.
Keywords: CDISC, SDTM 3.1, Data Standards, Data Transformation
Pages: 26 Size: 976 Kb 
tweet!  CDISC Submission and Compliance Training, The New Virtual Learning Methodology
  Dana Rafiee, Destiny Corporation; Michael Palmer, Zurich Biostatistics
Keywords: CDISC, submission, compliance training
Pages: 2 Size: 133 Kb 
tweet!  Implementing CDISC Data Models in the SAS® Metadata Server
  Michael Kilhullen, SAS Institute
Keywords: CDISC, data models, metadata
Pages: 7 Size: 416 Kb 
tweet!  UPDATE:CDISC Interchange Abstract Harmonizing CDISC Submission Models - SDTM and ADaM
  Edward Helton, Ph.D., SAS Institute; Stephen Ruberg, Ph.D., Eli Lilly; Cathy Barrows, GlaxoSmithKline; Musa Nsereko, Cephalon; Greg Anglin, Eli Lilly
Keywords: CDISC, SDTM, ADaM
Pages: 3 Size: 94 Kb 

Pharmaceutical Users Software Exchange 2005

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!  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!  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 
tweet!  Managing Clinical Trials Data using SAS
  Martin Rosenberg, MAJARO InfoSystems
Keywords: ClinAccess, SAS/SHARE, database, imaging, CDISC, clinical data management
Pages: 7 Size: 1530 Kb 
tweet!  Customer oriented CDISC implementation
  Edelbert Arnold, Accovion; Ulrike Plank, Accovion
Keywords: CDISC
Pages: 1 Size: 453 Kb 

Western Users of SAS Software 2005

tweet!  A Macro Mapping Date and Time Variable to CDISC Date and Time Variable
  Song Liu, Biogen Idec, San Diego, California; Brett Sellars, Biogen Idec, San Diego, California
Pages: 5 Size: 233 Kb 
tweet!  Data Integrity through DEFINE.PDF and DEFINE.XML
  Sy Truong, Meta-Xceed, Inc, Fremont, CA
Pages: 14 Size: 582 Kb 
tweet!  Transforming Data for CDISC and ISS
  Sy Truong, Meta-Xceed, Inc, Fremont, CA
Pages: 11 Size: 577 Kb 

Northeast SAS Users Group 2005

tweet!  MDMAP -- An Innovative Application Utilized in the Management of Clinical Trial Metadata
  Gregory Ridge, sanofi-avents Inc.; Neeru Bhardwaj, sanofi-avents Inc.
Keywords: clinical
Pages: 9 Size: 283 Kb 

Pharmaceutical SAS Users Group 2005

tweet!  CDISC for electronic submissions - A Table Translation Program
  John H. Adams, Boehringer Ingelheim; Kirill Tchernakov, Boehringer Ingelheim
Keywords: MACRO, CDISC, DYNAMIC PROGRAMMING, METADATA, EXCEL
Pages: 15 Size: 319 Kb 
tweet!  Implementation of the CDISC SDTM at the Duke Clinical Research Institute
  Jack Shostak, Duke Clinical Research Institute
Keywords: SDTM CDISC
Pages: 12 Size: 243 Kb 
Best Paper
tweet!  Strategies for Implementing SDTM and ADaM Standards
  Susan J. Kenny, Maximum Likelihood Solutions
Keywords: CDISC, SDTM, ADaM, FDA, analysis datasets, submission files
Pages: 8 Size: 239 Kb 
tweet!  Program Flow Design for Efficient CRT Programming
  Sam Mao, Quintiles, Inc.; Sid G. Morris, Quintiles, Inc.
Keywords: CRT, CDISC, SDM, SDTM, SDS, Programming Flow Design
Pages: 10 Size: 100 Kb 
tweet!  Some Statistical Programming Considerations for e-Submission
  Hang Pang, sanofi-aventis Pharma Inc.
Keywords: e-Submission, Define.pdf, Statistical Review Aids, SAS Data Transport File
Pages: 6 Size: 179 Kb 
tweet!  Pharmacovigilance and Drug Safety Reporting Algorithms (Content and Process)
  David Olaleye, SAS Institute
Keywords: CDISC, FDA
Pages: 8 Size: 145 Kb 
tweet!  SAS® Dataset Content Conversion to CDISC Data Standards
  Anthony Friebel, SAS Institute; Thomas Cox, SAS Institute; Edward Helton, SAS Institute
Keywords: CDISC, ODM, metadata
Pages: 10 Size: 486 Kb 

SAS Users Group International 30

tweet!  Data Standards and CDISC: A Statistical Perspective
  Steve Wilson
Pages: 1 Size: 26 Kb 
tweet!  Investigational Data in XML according to the CDISC Operational Data Model
  Edward D. Helton
Keywords: xml
Pages: 1 Size: 29 Kb 

Western Users of SAS Software 2004

tweet!  The Path to Data Standards
  Sy Truong, Meta?Xceed, Inc, Fremont, CA 
Keywords: Data Standard, CDISC, SDM, meta data
Pages: 10 Size: 519 Kb 
tweet!  Successful FDA Advisory Meetings by using Analysis Datasets
  Sandy Chang, Gilead Sciences, Inc., Foster City, California; Steve Wong, Gilead Sciences, Inc., Foster City, California
Keywords: Analysis Datasets, Advisory Committee Meeting, FDA, NDA, CDISC ADaM
Pages: 10 Size: 641 Kb 

Pharmaceutical SAS Users Group 2004

Best Paper
tweet!  Data Standards With and Without CDISC
  Sy J. Truong, Meta-Xceed, Inc.
Keywords: Data Standard, CDISC, SDM, meta data
Pages: 8 Size: 599 Kb 
tweet!  An FDA-Requested XML Replacement for SAS Version 5 Transport Files in U.S. Regulatory Submissions
  Michael C. Palmer, Zurich Biostatistics, Inc.
Keywords: FDA, version 5 transport files, ODM, XML, CDISC, submissions, CRT
Pages: 5 Size: 127 Kb 
tweet!  Defining and Validating CDISC Data Standards to XML in SAS Technology
  Anthony Friebel, SAS Institute; Edward Helton, SAS Institute; Eugenia Bastos, SAS Institute; Michael Kilhullen, SAS Institute; Jane Boone, CDISC
Keywords: CDISC, xml
Pages: 6 Size: 270 Kb 

SAS Users Group International 29

tweet!  XML in the DATA Step
  Michael C. Palmer
Keywords: XMLMAP CDISC TEMPLATE ODM ODS
Pages: 12 Size: 200 Kb 

Pharmaceutical SAS Users Group 2003

tweet!  CDISC, ADaM, and TTE: What Are These Acronyms and How Can They Help Me With My Filing?
  Sandra Minjoe, Genentech, Inc.; Judy Phelps, Pfizer
Keywords: ADaM analysis CDISC dataset FDA filing model submission time-to-event
Pages: 4 Size: 132 Kb 
tweet!  Clinical Data Model and FDA/CDISC Submissions
  Mark Edwards, Boston Scientific; Gajanan Bhat, Boston Scientific
Keywords: FDA CDISC SDM ODM XML
Pages: 10 Size: 321 Kb 
tweet!  CDISC: Why SAS® Programmers Need to Know
  Victor Sun, Novartis Pharmaceuticals Corp.
Keywords: CDISC Patient profile Electronic submission XML Metadata CRT datasets
Pages: 4 Size: 33 Kb 
tweet!  Testing CDISC's Operational Data Model in SAS
  Michael Palmer, Zurich Biostatistics, Inc; Julie Evans, CDISC
Keywords: CDISC ODM XML FDA Tekoa ZBI NDA BLA Zurich Biostatistics
Pages: 4 Size: 94 Kb 
Best Paper
tweet!  Using RTF, EPS and PDFMARK to Automate the Creation of Your DEFINE.PDF Document for Electronic Submissions
  Dirk Spruck, Aventis Behring.
Keywords: Electronic submission DEFINE.PDF RTF PDFMARK EPS
Pages: 6 Size: 138 Kb 
tweet!  Clinical Data Standards - An eSubmissions Perspective
  Shylendra Kumar, Datafarm, Inc; Gajanan Bhat, Boston Scientific Corporation
Keywords: esubmission crt item 11 enda ebla cdisc fda
Pages: 6 Size: 453 Kb 
tweet!  SAS Macro to Create ADDL Records to Estimate Dosing Not Represented in the Collected Data, In a NONMEM Population Pharmacokinetic Analysis Dataset
  Richard Schneck, Eli Lilly and Company; Mike Heathman, Eli Lilly and Company; Lynn Reynolds, Eli Lilly and Company
Keywords: ADDL Macro NONMEM Estimated Pharmacokinetic Dosing
Pages: 6 Size: 126 Kb 

SAS Users Group International 28

tweet!  XML in the DATA Step
  Michael C. Palmer
Keywords: XML, CDISC, ODM, DATA, clinical, FDA
Pages: 5 Size: 158 Kb 

Western Users of SAS Software 2002

tweet!  It's Easy If You Know How: Importing, Processing, and Exporting CDISC XML with SAS
  Michael C. Palmer, Zurich Biostatistics, Inc.
Pages: 4 Size: 676 Kb 

Pharmaceutical SAS Users Group 2002

tweet!  The CDISC Laboratory Data Interchange Standard: Using SAS® To Read and Write CDISC Compliant Data Sets and Files
  Margaret Hung, GlaxoSmithKlin; Philip Pochon, Covance Central Laboratory Services, Inc.
Keywords: CDISC, lab, lab data, XML, ASCII, SDM, ODM, metadata, Covance, GSK
Pages: 8 Size: 143 Kb 
tweet!  Implementing a Standardized Data Model - A Real Life Experience
  Curtis Wolf, DataCeutics; Paul Gilbert, DataCeutics; Patric Genyn, Janssen Pharmaceuticals
Keywords: Standardized, Data, Model, CDISC, submission, sdm, crt
Pages: 4 Size: 186 Kb 
tweet!  Various Techniques for Processing CDISC ODM XML
  Chris Olinger, ThotWave Technologies
Keywords: CDISC, xml
Pages: 34 Size: 91 Kb 
tweet!  It's Easy If You Know How: Importing, Processing, and Exporting CDISC XML with SAS®
  Michael Palmer, Zurich Biostatistics, Inc.
Keywords: cdisc, xml, odm, sdm, tekoa, xmlmap
Pages: 4 Size: 142 Kb 

Pharmaceutical SAS Users Group 2001

tweet!  A Method to Import, Process, and Export Arbitrary XML TM Files with SAS®
  Michael C. Palmer, Zurich Biostatistics, Inc., Morristown, NJ; Cecilia A. Hale, Zurich Biostatistics, Inc., Morristown, NJ
Keywords: XML, CDISC, databases, ODM, clinical data
Pages: 4 Size: 86 Kb 

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