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PharmaSUG proceedings: CDISC, Data Standards, Quality, FDA Compliance, Electronic Submission and Validation, 148 papers

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

Submission Standards
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 

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

Submission Standards
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 

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

CDISC
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 

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

CDISC
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 VanPeltNguyen, 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 

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

Regulatory Submissions and Standards
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 

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

Regulatory Submissions and Standards
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, Sheila Vince, 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 

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

FDA Compliance - Electronic Submission & Validation
tweet!  Automated Way to Develop Data Definition Document for Regulatory Submission
  Mustaq Ahmad, Merck & Co., Inc.
Keywords: Regulatory Submission Statistical Review Aid (SRA) Automation SAS Macro Quality Efficiency and Data Definition Document
Pages: 11 Size: 255 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 
tweet!  Can Change Control be Easy as a Right Mouse Click?
  Sy J Truong, Meta-Xceed, Inc.; Rory DeShano, MedImmune, Inc.
Keywords: change control validation program development
Pages: 9 Size: 500 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)
Best Paper
tweet!  CSI - Denver: Common SAS Issues in Our Programs and Tips for Better Investigation of Your SAS Code
  Rachel A Brown, Westat; Jennfier K Fulton, Westat
Keywords: testing validation documentation issues checking
Pages: 9 Size: 125 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 

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

FDA Compliance - Electronic Submission & Validation
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 
tweet!  Implementing SAS using Microsoft Windows Server and Remote Desktop
  Paul Gilbert, DataCeutics Inc; Steve Light, DataCeutics Inc
Keywords: Windows Server Remote Desktop Programming Platform Regulatory Compliance Electronic Submission
Pages: 5 Size: 71 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!  Preparing CTD (Common Technical Document) for FDA Submission
  Charlie Xu, AstraZeneca
Keywords: CTD FDA compliance SAS programming Pharmaceutical NDA sNDA
Pages: 7 Size: 229 Kb 
tweet!  Imputing ISO8601 Dates From Character Variables Containing Partial Dates
  John R. Gerlach, MaxisIT, Inc.
Pages: 4 Size: 134 Kb 

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

FDA Compliance
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 
2nd Best Paper
tweet!  Risk-Based Approach to SAS Program Validation
  Keith C. Benze, SEC Associates, Inc.
Keywords: computer validation computer compliance part 11
Pages: 7 Size: 132 Kb 
tweet!  Benefits of Validating SAS Systems in a Regulated Environment
  Sy T. Truong, Meta-Xceed Inc.
Keywords: Validation
Pages: 8 Size: 200 Kb 
tweet!  The Role of Analysis Datasets in Successful FDA Advisory Meetings
  Sandy Chang, Gilead Sciences, Inc; Steve Wong, Gilead Sciences, Inc.
Keywords: analysis dataset analysis metadata NDA submission
Pages: 9 Size: 640 Kb 
tweet!  Designing Helpful Audit Trails
  John Gorden, Quintiles
Keywords: audit trails documentation tracking sheet
Pages: 6 Size: 84 Kb 
tweet!  Quality Testing for Programs Used in Regulatory Submission
  Xiaohui Wang, Merck & Co., Inc.; Elaine Czarnecki, Merck & Co., Inc.
Keywords: program testing Regulatory submission validation
Pages: 4 Size: 30 Kb 

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

FDA Compliance: Electronic Submission and Validation
tweet!  XML Data Mapping under SAS 9 - From the Perspective of Electronic Submissions
  Tianshu Li, Merck & Co.
Keywords: XML SAS 9 Electronic Submissions
Pages: 7 Size: 38 Kb 
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!  Automation of Patient Narratives
  David C. Izard, GlaxoSmithKline; Eric M. Simms, GlaxoSmithKline
Keywords: FDA Regulatory Submission Subject Narratives CRTs ICH E3 NDA MAA
Pages: 6 Size: 36 Kb 
tweet!  Submission of Analysis Datasets and Documentation: Scientific and Regulatory Perspectives
  Dave Christiansen, Christiansen Consulting; Stephen E. Wilson, FDA
Keywords: Electronic Submission Clincal Trial Datasets Analysis Datasets Regulatory Guidance
Pages: 6 Size: 46 Kb 
tweet!  Build Portable Structures and Programs for Electronic Regulatory Submissions
  Wei Cheng, Isis Pharmaceuticals
Keywords: Portable Structure Electronic Regulatory Submission
Pages: 6 Size: 177 Kb 
Best Paper
tweet!  Using Cyclomatic Complexity to Assess Test Coverage for SAS Programs
  Michael C. Harris, Amgen, Inc.
Keywords: unit testing validation structured testing cyclomatic complexity
Pages: 5 Size: 177 Kb 
tweet!  A Useful Macro for Converting SAS Datasets into SAS Transport Files
  Xingshu Zhu, Merck & Co.; Shuping Zhang, Merck & Co.
Keywords: Data set size PROC CONTENTS SAS transport file FDA submission macro
Pages: 7 Size: 98 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!  eCTD - A New Standard for FDA Electronic Submission.
  Shawn Wang, MedXview, Inc.
Keywords: eCTD SAS FDA XML
Pages: 11 Size: 324 Kb 
tweet!  Critical Success Factors in Pharmaceutical Innovation
  Thomas H. Burger, Eli Lilly and Company; Michael S. Lajiness, Eli Lilly and Company.
Keywords: Innovation Cheminformatics Solutions Future Tools Bioinformatics
Pages: 4 Size: 99 Kb 

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

FDA Compliance - Electronic Submission and Validation
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!  A Validation Reporting System Solution
  Karen Walker, Walker Consulting LLC
Keywords: 21CFRPART11 Validation Reporting RISK LEGAL FDA
Pages: 6 Size: 199 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 
Best Paper
tweet!  Defining a Validation Process for end-user (Data Manager/Statisticians SAS Programs
  William Lawton, Boehringer Ingelheim (UK) Ltd
Keywords: Validation 21CFR Part 11 SAS ComplementSoft ASAP
Pages: 6 Size: 39 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 
tweet!  Automatically Output Rich Text Format Tables Using Dynamic Table Definitions in DATA _NULL_ Step
  Mei Tang, Ventana Clinical Research Corporation
Keywords: Tables SAS macro ODS RTF Proc Template Data _null_ ODS file Put _ods_
Pages: 10 Size: 190 Kb 
tweet!  Electronic Submission of SAS Data and Catalogs Simplified
  Adel Fahmy, Ingenix
Keywords: Electronic Submission FDA Compliance Derived Datasets Standard Datasets Database Design CRF Design
Pages: 6 Size: 88 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!  Error Checking and Version Control of SAS Programs
  Christopher Kania, Biogen
Keywords: Version Control Validation Error Checking Quality
Pages: 4 Size: 109 Kb 
tweet!  Progress Toward Standardization of Submissions with the Electronic Common Technical Document and the Evolving Standardization of Clinical Data
  Susan Bairnsfather, PharmaNet, Inc.
Keywords: standards electronic data submissions regulatory
Pages: 8 Size: 225 Kb 
tweet!  Standardizing Data processing and ePublishing in Pharmaceutical Industry
  Shawn Wang, medxview, Inc.
Keywords: SDLC ICH ODS PDF TLF FDA
Pages: 6 Size: 88 Kb 
tweet!  Generating Data Definition Tables for Electronic NDA Submissions
  Robert Abelson, KAI
Keywords: electronic submission data definition tables Output Delivery System macro
Pages: 4 Size: 61 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!  Coordinated Efforts for Preparing Statistical Review Aids
  Jian (James) Wu, Merck & Co.; Snow Fu, Merck & Co; Eric Zhang, Merck & Co.
Keywords: Statistical Review Aid FDA Electronic Submissions SAS Macros Web Development
Pages: 6 Size: 226 Kb 
tweet!  10 Things Every Programmer Should Know About Electronic Submissions
  Greg Silva, Biogen
Keywords: submissions FDA guidelines programming
Pages: 4 Size: 78 Kb 

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

FDA Compliance - Electronic Submission and Validation
tweet!  Clinical Data Model and FDA Submissions
  Shy Kumar, Datafarm, Inc; Gajanan Bhat, Boston Scientific Corporation
Keywords: Clinical Data Model Normalization FDA NDA electronic submission regulatory
Pages: 6 Size: 32 Kb 
tweet!  Using SAS® Macros to Construct Items 5 and 11 of an Electronic Submission
  Elizabeth Dennis, Quintiles, Inc; Jay Zhou, Quintiles, Inc.
Keywords: FDA electronic submission SAS macro item 11 transport file data definition table
Pages: 4 Size: 120 Kb 
tweet!  Data Definition Tables - Definition and Automation
  Matthew Becker, PharmaNet, Inc; Kitty Moses, Microcebus, Inc.
Keywords: data definition table ddt RTF automate CBER
Pages: 4 Size: 47 Kb 
tweet!  SAS® Coexistence with FDA 21 CFR Part 11, how far can we get?
  Gustav Sporon-Fiedler, H. Lundbeck A/; Marie Lassen, H. Lundbeck A/S
Pages: 6 Size: 91 Kb 
Best Paper
tweet!  ODS to RTF: Tips & Tricks
  Paul Hamilton, Immunex
Keywords: ods rtf word processing formatting
Pages: 10 Size: 66 Kb 

Pharmaceutical SAS Users Group 2001   May 20-23, 2001 - Boston, Massachusetts

FDA Compliance
tweet!  An Analysis Programming Process Focused on Data Derivation
  Lee Walke, PRA International, Charlottesville, VA
Pages: 4 Size: 102 Kb 
Best Paper
tweet!  Creating PDF TM Documents including Links, Bookmarks and a Table of Contents with the SAS® Software.
  Lex Jansen, NV Organon, The Netherlands
Keywords: SAS Acrobat PDF PdfMark
Pages: 10 Size: 316 Kb    Download the presentationdownload (.zip, 357 Kb)
tweet!  ESUB11, an Application to Automate the Production of Item 11 For NDA Electronic Submissions
  Margaret Hung, GlaxoSmithKline
Keywords: Visual Basic SAS 612 Oracle SAS CONNECT Adobe Acrobat electronic submission annotated CRF hypertext links
Pages: 8 Size: 214 Kb 
tweet!  FDA Reviewers as Ultimate End Users: Using the SAS System® to Construct e-Submissions that Actually Facilitate the NDA / BLA Review Process
  Rich Vachal, Industry Dynamics Associates, Somerset, NJ
Keywords: FDA,Reviewer,NDA,BLA,CDER,CBER,Guidelines,Fast Track,Accelerated Review,Priority Review,Rolling Submission,Clinicians,Statisticians,e-Sub,eSubmissions,electronic submissions,software life-cycle mod ...
Pages: 6 Size: 118 Kb 
Best Paper
tweet!  Pre-requisite to Effective Validation: Evaluating Your Clinical Trials Software Development Environment Using SEI's Capability Maturity Model for Software
  David C. Izard, GlaxoSmithKline, Collegeville, PA
Keywords: Validation SDLC Capability Maturity Model
Pages: 8 Size: 124 Kb 
tweet!  Softerware: Replace SAS® Programs with XML _ Documents to Help People and Computers Be Happier with Each Other
  Michael C. Palmer, Zurich Biostatistics, Inc., Morristown, NJ; Cecilia A. Hale, Zurich Biostatistics, Inc., Morristown, NJ
Keywords: XML ODS submissions integration automation documents
Pages: 6 Size: 298 Kb 
tweet!  Standards for Electronic Submissions to FDA
  Kay Obenshain, SAS; Presented by Sue Carroll, SAS
Pages: 4 Size: 22 Kb 
tweet!  The Changing Nature of SAS Programming in the Pharmaceuticals Industry
  Steven Light, DataCeutics, Inc.; Andy Siegel, Genzyme Corporation
Keywords: Pharmaceuticals esub regulatory compliance CRT XML publishing
Pages: 4 Size: 143 Kb 

Pharmaceutical SAS Users Group 2000   May 7-10, 2000 - Seattle, Washington

Electronic Submissions
tweet!  SAS® Version 8 ODS for Drug Safety Reporting (Without Use of HTML)
  Rene E. Laurencot
Keywords: html
Pages: 6 Size: 234 Kb 
tweet!  Creating PDF Files Using Data _NULL_
  Paul K. Slagle
Pages: 2 Size: 11 Kb 
Best Paper
tweet!  Creating Documents that create themselves with SAS® and XML TM
  Michael C. Palmer; Cecilia A. Hale
Keywords: xml
Pages: 4 Size: 374 Kb 

Pharmaceutical SAS Users Group 1998   May 17-20, 1998 - San Francisco, California

Canda/Esub
tweet!  Integrating SAS and Adobe Acrobat into Electronic Submissions
  Shylendra Kumar, Statsphere, Inc.; Andy Siegel, Astra USA, Inc.; Steve Light, Dataceutics, Inc.; Paul Gilbert, DataCeutics, Inc.
Keywords: Electronic FDA ESUP
Pages: 5 Size: 33 Kb 
SAS to Microsoft Word Interfaces for Producing Publications Quality Output: With Examples from The Pharmaceutical Industry
  Clark Roberts, Decision Analytics
Using Adobe Acrobat® to produce indexed electronic documents from SAS® output for NDA filings
  Clark Roberts, Decision Analytics

Pharmaceutical SAS Users Group 1997   May 11-14, 1997 - Hilton Head, South Carolina

CANDA/Electronic Submissions
tweet!  FDA Initiatives: Electronic Data Interchange (EDI) for Drug Safety Monitoring
  Bill Calvert, FDA/CDER/OEB/DPE
Pages: 3 Size: 206 Kb 
tweet!  Integrating SAS Programs With A Multi-Functional Computer Assisted NDA (CANDA)
  Kathryn B. Eisen, Covance, The Development Services Company, Inc., Princeton, NJ; Carolyn 1. Kingman, Covance, The Development Services Company, Inc., Princeton, NJ
Keywords: canda
Pages: 4 Size: 236 Kb 
tweet!  Design of the Clinical Data Portion of a CANDA to Facilitate Review by CDER
  Kay Obenshain, SAS Institute, Inc., Cary, NC
Keywords: canda
Pages: 5 Size: 394 Kb 
tweet!  How to Use CD-ROM as a Simplified CANDA
  Steve Wong, IBAH, Inc., Emeryville, CA
Keywords: canda
Pages: 4 Size: 283 Kb 
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