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SAS PharmaSUG proceedings: CDISC, 361 papers

Pharmaceutical SAS Users Group 2017   May 14-17, 2017 - Baltimore, Maryland

tweet!  Three Issues and Corresponding Work-Around Solution for Generating Define.xml 2.0 Using Pinnacle 21 Enterprise
  Jeff Xia, Merck; Lugang Larry Xie, Merck & Co.; Shari Lisnov, Merck &Co.
Keywords: DEFINE 2.0 Pinnacle 21, CDISC, xml
Pages: 6 Size: 526 Kb 
tweet!  An Efficient Solution to Efficacy ADaM Design and Implementation
  Chengxin Li, Pfizer; Zhongwei Zhou, Pfizer
Keywords: efficacy ADaM deisgn implementation CDISC
Pages: 7 Size: 556 Kb 
Best Paper
tweet!  Laboratory Data Standardization with SAS
  Charley Wu, Astellas
Keywords: SAS Lab Data SDTM Standardization
Pages: 12 Size: 2398 Kb 
tweet!  Challenge for Dramatic Streamlining of TLFs Creation Process with SAS and Java
  Yohei Takanami, Takeda Pharmaceutical Company, Ltd.; Fumihiro Yamasaki, Takeda Pharmaceutical Company, Ltd.
Keywords: Report ODS System Standardization Java TLF Macro CDISC ADaM GUI
Pages: 8 Size: 443 Kb 
tweet!  A novel method to track mapping of all CRF variables into SDTM datasets.
  Aishhwaryapriya Elamathivadivambigai, Seattle Genetics
Keywords: SDTM Mapping eCRF CDISC
Pages: 7 Size: 381 Kb 
tweet!  Conversion of CDISC specifications to CDISC data - specifications driven SAS programming for CDISC data mapping
  Yurong Dai, Eli Lilly; Jameson Cai, Eli Lilly
Keywords: CDISC
Pages: 9 Size: 415 Kb 
tweet!  Data Integrity: One step before SDTM
  Pavan Kathula, Anna University at Chennai; Sonal Torawane, University of Pune
Keywords: Data Integrity CDISC
Pages: 9 Size: 346 Kb 
tweet!  The Untapped Potential of the Protocol Representation Model
  Frank DiIorio, CodeCrafters, Inc.; Jeffrey Abolafia, Rho, Inc.
Keywords: PRM Protocol CDISC Metadata end-to-end structured authoring
Pages: 10 Size: 429 Kb 
CDISC's CDASH and SDTM: Why You Need Both!
  Kit Howard, CDISC; Shannon Labout, CDISC
Keywords: CDISC
tweet!  SDTM - Just a Walk in the (Theme) Park, Exploring SDTM in the Most Magical Place on Earth
  Christine Mcnichol, Chiltern International
Keywords: SDTM CDISC
Pages: 9 Size: 432 Kb 
tweet!  The CDISC Trial Design Model (TDM), the EPOCH variable, and the Treatment Emergent Flag: How to Leverage these to Improve Review
  Thomas Guinter, Independent
Keywords: CDISC SDTM EPOCH TRIAL DESIGN
Pages: 4 Size: 203 Kb 
tweet!  Implementation of STDM Pharmacogenomics/Genetics Domains on Genetic Variation Data
  Linghui Zhang, Merck
Keywords: Implementation SDTM Pharmacogenomics Biomarkers Genetic Variation
Pages: 12 Size: 906 Kb 
Best Paper
tweet!  Where Is the Link Broken - Another Look at SDTM Oncology Tumor Packages
  Hong Wang, Boehringer Ingelheim; Ke Xiao, Boehringer Ingelheim
Keywords: SDTM Oncology Radiologic CDISC
Pages: 12 Size: 697 Kb 
tweet!  The CDISC SDTM Exposure Domains (EX & EC) Demystified. How EC Helps You Produce A Better (more compliant) EX.
  Thomas Guinter, Independent
Keywords: CDISC SDTM Exposure. EC and EX
Pages: 9 Size: 801 Kb 
tweet!  RELREC - SDTM Programmer's Bermuda Triangle
  Charumathy Sreeraman, Ephicacy Lifescience Analytics
Keywords: related records relrec GRPID SPID LINKID, CDISC
Pages: 12 Size: 904 Kb 
tweet!  Leveraging metadata when mapping to CDISC Standards with SAS® machine learning in a Results as a Service plus Model (RAAS+)
  Ben Bocchicchio, SAS Institute; Sandeep Juneja, SAS Institute; Preetesh Parikh, SAS Institute
Keywords: PharmaSUG 2017 Data Mapping Auto Mapping preetesh parikh ben bocchicchio sandeep juneja CDISC SDTM ADAM
Pages: 6 Size: 782 Kb 
tweet!  Considerations and Conventions in the Submission of the SDTMIG Tumor and Response Domains
  Jerry Salyers, Accenture Life Sciences; Fred Wood, Accenture Life Siences
Keywords: SDTM Oncology Tumor Lesion CDISC
Pages: 7 Size: 47 Kb 
tweet!  Considerations in Submitting Standardized Electronic Data Under the Animal Rule: The Use of Domains in the SDTMIG and the SENDIG
  Fred Wood, Accenture Life Siences
Keywords: Animal Rule CDISC
Pages: 7 Size: 174 Kb 
tweet!  Common Programming Errors in CDISC data
  Sergiy Sirichenko, Pinnacle 21
Keywords: Data Validation Pinnacle 21 FDA PMDA CDISC Data Issues
Pages: 9 Size: 74 Kb 
tweet!  ADaM Compliance - Validating your Specifications
  Trevor Mankus, PRA Health Sciences; Kent Letourneau, PRA Inernational
Keywords: CDISC ADaM Specifications SAS Metadata PharmaSUG Data Standards Validation
Pages: 9 Size: 590 Kb 
Best Paper
tweet!  ADaM Grouping: Groups, Categories, and Criteria. Which Way Should I Go?
  Jack Shostak, DCRI
Keywords: CDISC ADaM
Pages: 12 Size: 460 Kb 
tweet!  Clarifications About ADaM Implementation Provided in ADaMIG Version 1.1
  John Troxell, Accenture
Keywords: CDISC ADaM ADaMIG
Pages: 5 Size: 224 Kb 
tweet!  Standardized, Customized or Both? Defining and Implementing (MedDRA) Queries in ADaM Data Sets
  Richann Watson, Experis; Karl Miller, inVentiv Health
Keywords: CDISC
Pages: 7 Size: 183 Kb 
tweet!  LBTEST/LBSTRESU and ADaM lab parameters: The dilemma of mapping one-to-many or many-to-one
  Michelle Barrick, Eli Lilly and Company
Keywords: ADaM ADLB PARAMCD CDISC
Pages: 5 Size: 164 Kb 
tweet!  Programming Efficiency in the Creation of ADaM BDS Datasets
  Ellen Lin, Amgen Inc
Keywords: ADaM BDS Programming Efficiency CDISC
Pages: 11 Size: 459 Kb 
tweet!  Deriving Rows in CDISC ADaM BDS Datasets
  Sandra Minjoe, Accenture
Keywords: CDISC ADaM BDS parameter DTYPE BASETYPE baseline ADaMIG
Pages: 12 Size: 548 Kb 
tweet!  ADQRS: Basic Principles for Building Questionnaire, Rating and Scale Analysis Datasets
  Nancy Brucken, inVentiv Health Clinical; Karin Lapann, Shire
Keywords: ADaM ADQRS QRS questionnaire rating scale BDS
Pages: 6 Size: 85 Kb 
tweet!  A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices
  Carey Smoak, DataCeutics, Inc.
Keywords: SDTM DEVICE CDISC
Pages: 16 Size: 252 Kb 
tweet!  Usage of Pinnacle 21 Community Toolset 2.x.x for Clinical Programmers
  Sergiy Sirichenko, Pinnacle 21; Michael Digiantomasso, Pinnacle 21
Keywords: Validation Define.xml Pinnacle 21 OpenCDISC CDISC FDA PMDA
Pages: 23 Size: 1695 Kb 
tweet!  How to find the best MDR solution for your organization
  Kevin Lee, Clindata Insight
Keywords: MDR CDISC Integration selection SAS
Pages: 3 Size: 242 Kb 
tweet!  SDTM Cartography - Learn To Create SDTM Mapping Specifications
  Donna Sattler, Eli Lilly; Mike Lozano, Eli Lilly and Company
Keywords: Mapping Specification Specs CDISC SDTM Standardization Integration
Pages: 7 Size: 336 Kb 
tweet!  Building a Fast Track for CDISC: Practical Ways to Support Consistent, Fast and Efficient SDTM Delivery
  Steve Kirby, Chiltern International Ltd; Mario Widel, Eli Lilly; Richard Addy, Chiltern International Ltd
Keywords: CDISC SDTM CRF OPTIMIZATION METADATA
Pages: 14 Size: 678 Kb 
tweet!  CDISC Compliant NCA PK Parameter Analysis When Using Phoenix® WinNonlin®
  Renfang Hwang, Celgene Coporation
Keywords: NCA PK Parameter CDISC
Pages: 11 Size: 949 Kb 
tweet!  Developing ADaM Dataset for Cardiovascular Outcome Studies
  Joanne Zhou, GSK; Rakesh Kumar, Mr.; David Wade, Mr.; David Chen, Mr.
Keywords: ADaM Cardiovascular CDISC
Pages: 4 Size: 225 Kb 
tweet!  Pilot Meta-Analysis of HPA Axis Suppression Studies on Topical Corticosteroids using ADaM Datasets derived from Legacy Data
  Lillian Qiu, FDA; Hon-Sum Ko, FDA
Keywords: Topical corticosteroid potency Hypothalamic-pituitary-adrenal axis ACTH (Cortrosyn®) stimulation Meta-analysis CDISC SDTM CDISC ADaM Legacy data conversion
Pages: 5 Size: 139 Kb 
tweet!  A custom ADaM domain for time to event analysis in adverse events
  John Saida Shaik, Seattle Genetics Inc.
Keywords: CDISC
Pages: 4 Size: 117 Kb 
tweet!  Remove the Error: Variable length is too long for actual data
  Eric Larson, inVentiv Health
Keywords: P21 OpenCDISC
Pages: 9 Size: 48 Kb 
tweet!  What Are Occurrence Flags Good For Anyway?
  Nancy Brucken, inVentiv Health Clinical
Keywords: ADaM OCCDS occurrence flags AOCCFL
Pages: 4 Size: 27 Kb 
tweet!  Basic SDTM House-Keeping
  Emmy Pahmer, inVentiv Health
Keywords: SDTM checks CDISC
Pages: 3 Size: 29 Kb 
tweet!  Multi-Dimensional Arrays: Add Derived Parameters
  Siddharth Kumar Mogra, GCE Solutions Inc
Keywords: Multi Dimensional Arrays, SAS, Lab, ADaM, SDTM, GCE, Solutions, Siddharth Kumar Mogra, Siddharth, Mogra, Palanpur, PharmaSUG, Clinical, Statistical, Analysis, Dataset, Outputs, TLFs, Table, Laborat ...
Pages: 7 Size: 326 Kb 
tweet!  How will FDA Reject non-CDISC submission?
  Kevin Lee, Clindata Insight
Keywords: CDISC FDA rejection RTF eCTD eSubmission
Pages: 6 Size: 247 Kb 
tweet!  Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission
  Sandra Minjoe, Accenture
Keywords: FDA binding guidance ADaM define ADRG CDISC programs TCG
Pages: 12 Size: 753 Kb 
tweet!  Good versus better SDTM: Including Screen Failure Data in the Study SDTM?
  Henry Winsor, Relypsa Inc.; Mario Widel, Eli Lilly
Keywords: SDTM Screen Failure, CDISC
Pages: 9 Size: 503 Kb 
tweet!  Good Data Validation Practice
  Sergiy Sirichenko, Pinnacle 21; Max Kanevsky, Pinnacle 21
Keywords: FDA PMDA CDISC Validation Rejection Criteria Pinnacle 21 OpenCDISC
Pages: 10 Size: 241 Kb 
tweet!  Creating Define-XML version 2 including Analysis Results Metadata with the SAS® Clinical Standards Toolkit
  Lex Jansen, SAS Institute Inc.
Keywords: SAS CST CDISC Define-XML define.xml metadata ARM ADaM
Pages: 31 Size: 1790 Kb    Download the presentationdownload (.pdf, 2165 Kb)
tweet!  The Do's/Don'ts, An SDTM Validation Perspective. The should/shouldn't when explaining issues in the Study Data Reviewers Guide
  Thomas Guinter, Independent
Keywords: submission standards CDISC
Pages: 8 Size: 501 Kb 
tweet!  Documenting Traceability for the FDA: Clarifying the Legacy Data Conversion Plan & Introducing the Study Data Traceability Guide
  David Izard, Chiltern; Kristin Kelly, Merck; Jane Lozano, Eli Lilly
Keywords: CDISC FDA Study Data Technical Conformance Guide Standardized Study Data Legacy Data Conversion Plan Report Study Data Standardization Plan
Pages: 9 Size: 158 Kb 
tweet!  Quality Check your CDISC Data Submission Folder Before It Is Too Late!
  Bhavin Busa, Vita Data Sciences (a division of Softworld, Inc.)
Keywords: eCTD CDISC Data Quality
Pages: 9 Size: 527 Kb 
tweet!  Converting Non-Imputed Dates for SDTM Data Sets With PROC FCMP
  Noory Kim, CROS NT
Keywords: CDISC
Pages: 12 Size: 419 Kb 

Pharmaceutical SAS Users Group 2016   May 8-11, 2016 - Denver, Colorado

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!  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!  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!  “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!  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!  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!  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!  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!  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 
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 
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!  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 
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 

Pharmaceutical SAS Users Group 2015   May 17-20, 2015 - Orlando, Florida

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 
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!  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!  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!  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!  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!  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!  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!  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 

Pharmaceutical SAS Users Group 2014   June 1-4, 2014 - San Diego, California

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 
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!  Having Fun with RACE Derivation in DM Domain
  Chunxia Lin, InVentiv Health Clinical, Ossining, NY; Deli Wang, Tarrytown, NY
Keywords: SDTM DM RACE
Pages: 5 Size: 38 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!  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!  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 
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!  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 
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)
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 
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)
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 

Pharmaceutical SAS Users Group 2013   May 12-15, 2013 - Chicago, Illinois

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 
tweet!  A Simple Interface for Metadata
  Magnus Mengelbier, Limelogic AB, Malmö, Sweden
Keywords: interface metadata data set table listing figure graph protocol statistical analysis plan sap shells sas macro program sdtm adam cdisc html javascript
Pages: 8 Size: 306 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!  Clinical Reporting by Elements
  Magnus Mengelbier, Limelogic AB, Malmö, Sweden
Keywords: sas clinical study pooled pooling integrated integration report elements component interface metadata r splus s-plus winnonlin nonmem winbugs spss cdisc sdtm adam odm xpt statistics summary data se ...
Pages: 9 Size: 241 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!  Building Traceability for End Points in Analysis Datasets Using SRCDOM, SRCVAR, and SRCSEQ Triplet
  Xiangchen Cui, Vertex Pharmaceuticals Inc., Cambridge, MA; Tathabbai Pakalapati, Cytel Inc., Cambridge, MA; Qunming Dong, Vertex Pharmaceuticals Inc., Cambridge, MA
Keywords: ADaM Traceability
Pages: 12 Size: 169 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!  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 

Pharmaceutical SAS Users Group 2012   May 13-16, 2012 - San Francisco, California

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!  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 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 
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!  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!  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!  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 

Pharmaceutical SAS Users Group 2011   May 8-11, 2011 - Nashville, Tennessee

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!  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!  Keeping Patients on Schedule, The Art of Visit Windows and Cycle Slotting
  Paul Slagle, United Biosource Corp., Ann Arbor, MI
Keywords: Technical Techniques visits windows adam sdtm
Pages: 4 Size: 40 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 

Pharmaceutical SAS Users Group 2010   May 23-26, 2010 - Orlando, Florida

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!  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!  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 

Pharmaceutical SAS Users Group 2009   May 31 - June 3, 2009 - Portland, Oregon

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!  An Implementation of CDISC SDTM and ADaM Standards at MedImmune
  Alan Meier
Keywords: CDISC
Pages: 11 Size: 323 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 

Pharmaceutical SAS Users Group 2008   June 1-4, 2008 - Atlanta, Georgia

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!  The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
  Fred Wood, Octagon Research Solutions
Keywords: CDISC
Pages: 8 Size: 213 Kb 
tweet!  SAS, CDISC and Clinical Data Integration
  Peter Villiers, SAS Institute Inc.
Keywords: CDISC
Pages: 27 Size: 4697 Kb 

Pharmaceutical SAS Users Group 2007   June 3-6, 2007 - Denver, Colorado

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 

Pharmaceutical SAS Users Group 2006   May 21-24, 2006 - Bonita Springs, Florida

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 SAS Users Group 2005   May 22-25, 2005 - Phoenix, Arizona

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 

Pharmaceutical SAS Users Group 2004   May 23-26, 2004 - San Diego, California

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 

Pharmaceutical SAS Users Group 2003   May 4-7, 2003 - Miami, Florida

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!  Automating the Creation of Data Definition Tables (Define.pdf) using SAS® Version 8.2
  Eugene Yeh, PharmaNet, Inc.; Syamala Kasichainula, PharmaNet, Inc; Katie Lanier, PharmaNet, Inc.
Keywords: Define.pdf automation item 11 case report tabulation FDA electronic NDA submission ODS PDF metadata program documentation derived variable definition data definition table
Pages: 8 Size: 173 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 

Pharmaceutical SAS Users Group 2002   May 5-8, 2002 - Salt Lake City, Utah

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   May 20-23, 2001 - Boston, Massachusetts

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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