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SAS Conference Proceedings:
May 14-17, 2017, Baltimore, Maryland, 209 papers
PharmaSUG 2017   PharmaSUG 2016   PharmaSUG 2015   PharmaSUG 2014   PharmaSUG 2013   PharmaSUG 2012   PharmaSUG 2011   PharmaSUG 2010   PharmaSUG 2009   PharmaSUG 2008   PharmaSUG 2007   PharmaSUG 2006   PharmaSUG 2005   PharmaSUG 2004   PharmaSUG 2003   PharmaSUG 2002   PharmaSUG 2001   PharmaSUG 2000   PharmaSUG 1998   PharmaSUG 1997  

[Original source: http://www.pharmasug.org/2017-proceedings.html]

Pharmaceutical SAS Users Group 2017: Best Papers and honorable mentions

Here Comes The Smart Mock Table: A Novel Way of Creating Clinical Summary Tables Without Any Table Programming (No Kidding!)
  Joseph Hinson, inVentiv Health (Best Paper in Applications Development)
Laboratory Data Standardization with SAS
  Charley Wu, Astellas (Best Paper in Applications Development)
Making Documents 'Intelligent' with Embedded Macro Calls, DOSUBL and Proc STREAM: An example with the CONSORT Flow Diagram
  Joseph Hinson, inVentiv Health (Best Paper in Beyond the Basics)
SAS Programmer's Guide to Life on the SAS Grid
  Eric Brinsfield, Meridian Analytics (Best Paper in Beyond the Basics)
What Makes a Candidate Stand Out?
  Edward Slezinger, Fred Hutchinson Cancer Research Center - SCHARP (Best Paper in Career Planning)
Check Your Data: Tools for Automating Data Assessment
  Paul Stutzman, Axio Research (Best Paper in Data Integrity)
Where Is the Link Broken - Another Look at SDTM Oncology Tumor Packages
  Hong Wang, Boehringer Ingelheim; Ke Xiao, Boehringer Ingelheim (Best Paper in Data Standards)
ADaM Grouping: Groups, Categories, and Criteria. Which Way Should I Go?
  Jack Shostak, DCRI (Best Paper in Data Standards)
Automated DSMB Presentation in SAS: Yeah, I'd Submit That! How to auto populate PowerPoint presentations so you don't have to
  Brett Jepson, Rho Inc.; Kaitie Lawson, Rho, Inc. (Best Paper in Data Visualizations and Graphics)
Multinomial Logistic Regression Models With Sas® Proc Surveylogistic
  Marina Komaroff, Noven Pharmaceuticals (Best Paper in Healthcare Analytics)
Good Programming Practices at Every Level
  Maria Dalton, GlaxoSmithKline (Best Paper in Industry Basics)
Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue!
  Gloria Boye, Vita Data Sciences (a division of Softworld, Inc); Aparna Poona, Softworld, Inc. (Life Sciences); Bhavin Busa, Vita Data Sciences (a division of Softworld, Inc.) (Best Paper in Management and Support)
Facebook Data Analysis with SAS® Visual Analytics
  Prasoon Sangwan, TATA Consultancy Services Ltd; Vikrant Bisht, TATA Consultancy Services Ltd; Piyush Singh, TCS; Ghiyasuddin Mohammed Faraz Khan, Sapphire Software Solutions Inc. (Best Paper in Posters)
Mindfulness at Work: Handling Stress and Changes Gracefully and Be the Leader You Were Born To Be
  Helena Ho, Astrazeneca (Best Paper in Posters)
Is There a Date In That Comment? Use SAS To Find Out.
  Keith Hibbetts, Eli Lilly and Company (Best Paper in Quick Tips)
Multiple Imputation: A Statistical Programming Story
  Chris Smith, Cytel Inc.; Scott Kosten, DataCeutics Inc. (Best Paper in Statistics and Pharmacokinetics)
Awareness from Electronic Data Submission to PMDA and FDA -- Lesson & Learnt from hands-on experiences --
  Yuichi Nakajima, Novartis; Takashi Kitahara, Novartis; Ryan Hara, Novartis AG (Best Paper in Submission Standards)
Dear Dave, Please See the .LST File for Our Validation Differences. Thanks, Bad Validation Programmer
  Tracy Sherman, Ephicacy; David Carr, Ephicacy; Brian Fairfield-Carter, InVentiv Health (Best Paper in Techniques and Tutorials)

Applications Development
Beyond the Basics
Career Planning
Data Integrity
Data Standards
Data Visualizations and Graphics
FDA Wednesday
Hands-on Training
Healthcare Analytics
Industry Basics
Management and Support
Posters
Quick Tips
Statistics and Pharmacokinetics
Submission Standards
Techniques and Tutorials

Applications Development
Best Paper
tweet!  Here Comes The Smart Mock Table: A Novel Way of Creating Clinical Summary Tables Without Any Table Programming (No Kidding!)
  Joseph Hinson, inVentiv Health
Keywords:  DOSUBL  PROC STREAM  SYSFUNC  MACROS: 
Pages: 19 Size: 453 Kb 
tweet!  Automated Generation of Clinical Study Reports using SAS® and RTF (Literate programming)
  Rajaram Venkatesan, Cognizant Technology Solution; Julien Sauser, Nestle Research Center; Carlos Antonio De Castro, Nestle Research Center
Keywords:  automation 
Pages: 13 Size: 650 Kb 
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!  A Vivid and Efficient Way to Highlight Changes in SAS Dataset Comparison
  Jeff Xia, Merck; Lugang Larry Xie, Merck & Co.; Shunbing Zhao, Merck & Co.
Pages: 12 Size: 238 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 
tweet!  Obtaining an Automated Summary of PROC COMPARE Results: &SYSINFO and VB Script
  Umesh Gautam, Trial Runners; Jeff Roberts, Chiltern International
Keywords:  proc compare  lst  sysinfo  vbscript 
Pages: 5 Size: 304 Kb 
tweet!  Work with me here...(or there or anywhere): Practical Cloud Collaboration with JMP Clinical for Clinical Trial Data Reviews
  Kelci Miclaus, SAS; Drew Foglia, SAS Institute, Inc.
Pages: 14 Size: 1832 Kb 
tweet!  Building a Better Dashboard Using SAS® Base Software
  Kirk Paul Lafler, Software Intelligence Corporation; Josh Horstman, Nested Loop Consulting; Roger Muller, Data To Events, Inc
Keywords:  sas  dashboard  dashboards  interactive dashboards  drill-down  drill-down dashboards  histogram  hbar chart  vbar chart  pie chart  sgplot  sgscatter  sgpanel  sgrender  sas author  sas press  sas consultant  sas trainer  sas presenter  Lafler  Kirk Lafler  Kirk Paul Lafler  @sasNerd  Roger Muller  Joshua M. Horstman 
Pages: 17 Size: 888 Kb 
tweet!  Important and Valuable Things You Can Do with SAS® Metadata DICTIONARY Tables and SASHELP Views
  Kirk Paul Lafler, Software Intelligence Corporation
Keywords:  SAS  metadata  sas metadata  DICTIONARY  DICTIONARY tables  system tables  SASHELP views  system views  author  sas press  sas press author  consultant  sas consultant  sql  sql consultant  Lafler  Kirk Lafler  Kirk Paul Lafler  @sasNerd 
Pages: 8 Size: 931 Kb 
Best Paper
tweet!  Laboratory Data Standardization with SAS
  Charley Wu, Astellas
Keywords:  SAS  Lab Data  SDTM  Standardization 
Pages: 12 Size: 2398 Kb 
tweet!  Generating Homeomorphically Irreducible Trees (Solving the Blackboard Problem in the Movie "Good Will Hunting")
  John R Gerlach, Dataceutics, Inc.
Keywords:  PharmaSUG  2017  AD11 
Pages: 14 Size: 222 Kb 
tweet!  Using SAS® ODS EXCEL Destination with SAS University Edition® to send graphs to Excel
  William E Benjamin Jr, Owl Computer Consultancy LLC
Pages: 15 Size: 1541 Kb 
tweet!  Using SAS® for Application Programming Interface Requests
  Mike Jadoo, SAS user
Keywords:  API 
Pages: 9 Size: 564 Kb 
R Shiny Clinical Review Tools on the Horizon
  Jimmy Wong, FDA
  Download the presentationdownload (.html, 3570 Kb)
tweet!  Excel-VBA Tool to Auto-Create Validation log and Review Form using List of TLF's.
  Balaji Ayyappan, inVentiv Clinical
Keywords:  AD15  -  PharmaSUG2017  paper  -  by  Balaji  Ayyappan 
Pages: 6 Size: 170 Kb 
tweet!  Migration to SAS Grid: Steps, Successes, and Obstacles for Performance Qualification Script Testing
  Amanda Lopuski, Chiltern; Yongxuan Mike Tan, Chiltern
Keywords:  PharmaSUG  2017  AD16 
Pages: 6 Size: 131 Kb 
tweet!  Metadata integrated programming
  Jesper Zeth, Novo Nordisk A/S; Jan Skowronski, Novo Nordisk A/S
Keywords:  Metadata  Programming 
Pages: 12 Size: 1345 Kb 
tweet!  Leveraging Centralized Programming Resources Using SAS Integration Technologies
  Tony Chang, Global Statistical Programming, Amgen Inc
Keywords:  SAS Integration Technologies  Java Client 
Pages: 8 Size: 473 Kb 
tweet!  SAS Application to Automate a Comprehensive Review of DEFINE and All of its Components
  Walter Hufford, Novartis Pharmaceuticals; Vincent Guo, Novartis Pharmaceuticals; Mijun Hu, Novartis Pharmaceuticals
Keywords:  Comprehensive  automated  DEFINE  review 
Pages: 8 Size: 388 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!  Integration of multiple files into a study report using Word VBA macros
  Heather Wood, DCRI; Jack Shostak, DCRI
Keywords:  integration Word VBA report  macro 
Pages: 10 Size: 544 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!  Supporting the CDISC Validation Life-Cycle with Microsoft Excel VBA
  Eric Crockett, Chiltern International
Keywords:  VBA  CDISC  Excel  Pinnacle 21  OCV  Annotations  Life-Cycle  PharmaSUG 2017 AD23 
Pages: 7 Size: 675 Kb 
tweet!  SAS Macro for Derivation of Best Overall Response per RECIST v. 1.1
  Bob Zhong, Johnson & Johnson; Jiangfan Li, Johnson & Johnson; Hong Xie, Johnson & Johnson; Peter De Porre, Johnson & Johnson; Kenneth Maahs, Johnson & Johnson; Kyounghwa Bae, Johnson & Johnson
Keywords:  RECIST 1.1  Best Overall Response  Confirmed CR/PR  Unconfirmed CR/PR  CR  PR  uCR  uPR  SD  PD  NE  SAS Macro Tool 
Pages: 9 Size: 834 Kb 
tweet!  Controlled Terminology Without Excel
  Mike Molter, Wright Ave Partners
Keywords:  Controlled  Terminology  Excel  Python  Graph  Database 
Pages: 15 Size: 673 Kb 
tweet!  Stop waiting - Get notification email at the end of SAS® code execution using SAS® EMAIL Engine
  Nirav Darji, GCE Solutions pvt ltd
Keywords:  EMAIL  SAS  SAS email engine  filename 
Pages: 11 Size: 315 Kb 
Beyond the Basics
tweet!  One Project, Two Teams: The Unblind leading the Blind
  Kristen Harrington, Rho, Inc.
Keywords:  Unblinding  Teams 
Pages: 5 Size: 58 Kb 
Best Paper
tweet!  Making Documents 'Intelligent' with Embedded Macro Calls, DOSUBL and Proc STREAM: An example with the CONSORT Flow Diagram
  Joseph Hinson, inVentiv Health
Keywords:  CONSORT  Proc STREAM  DOSUBL  SYSFUNC  macro 
Pages: 15 Size: 451 Kb 
tweet!  The REPORT Procedure and ODS Destination for Microsoft Excel: The Smarter, Faster Way to Create First-Rate Excel Reports
  Jane Eslinger, SAS Institute
Pages: 20 Size: 1067 Kb 
tweet!  Reporting Non-Printable and Special Characters for Review in Excel
  Abhinav Srivastva, Gilead Sciences
Keywords:  Non-printable characters  special characters  reporting special characters in excel  data checks 
Pages: 11 Size: 759 Kb 
tweet!  I've Got to Hand It to You; Portable Programming Techniques
  Art Carpenter, CA Occidental Consultants
Keywords:  Macro  %SYSGET  AUTOEXEC  %SYSFUNC  portable  SAS_EXECFILEPATH  Batch submissions  UNIX  Windows 
Pages: 21 Size: 417 Kb 
tweet!  Good artists copy; Great artists steal; (implement pseudo R, JQuery & code in Base SAS without installing R or other Applications
  Hui Liu, MSD
Keywords:  R  Base SAS 
Pages: 8 Size: 368 Kb 
tweet!  Simplifying Your %DO Loop with CALL EXECUTE
  Arthur Li, City of Hope
Pages: 5 Size: 65 Kb 
tweet!  Using Hash tables for AE search strategies
  Vinodita Bongarala, Seattle Genetics; Liz Thomas, Seattle Geneticd
Keywords:  Hash Tables  AE Search Strategies 
Pages: 6 Size: 199 Kb 
tweet!  Expansion of Opportunities in Programming: DS2 Features and Examples of Usage Object Oriented Programming in SAS
  Serhii Voievutskyi, Experis Clinical
Keywords:  DS2 
Pages: 11 Size: 446 Kb 
tweet!  A Macro to carry values through observations forwards or backwards over null values within a by group or a SAS(R) dataset.
  Timothy Harrington, SAS Programmer
Keywords:  by group processing  macro 
Pages: 9 Size: 56 Kb 
Best Paper
tweet!  SAS Programmer's Guide to Life on the SAS Grid
  Eric Brinsfield, Meridian Analytics
Keywords:  SAS  Grid  Linux  Performance  Programming  Optimization 
Pages: 18 Size: 884 Kb 
tweet!  Programming LYRIC Response in Immunomodulatory Therapy Trials
  Yang Wang, Seattle Genetics
Keywords:  LYRIC 
Pages: 5 Size: 146 Kb 
tweet!  Harnessing the Power of the Manifest File in the SAS® Life Science Analytics Framework
  Kevin Clark, SAS Institute
Keywords:  Job manifest  clinical trials  job creation  API macros  Life Sciences Analytics Framework 
Pages: 3 Size: 240 Kb 
tweet!  A SAS®sy Study of eDiary Data
  Amie Bissonett, inVentiv Health Clinical
Keywords:  eDiary  Data 
Pages: 5 Size: 225 Kb 
tweet!  A Case of assessing adverse events of interest based on their grade changes
  Sriramu Kundoor, Seattle Genetics
Keywords:  Adverse Events  AE 
Pages: 7 Size: 426 Kb 
tweet!  Don't Get Lost! A High-efficiency, Low-tech Solution for Navigating Your Department's Many-Many-Many SOPs and Guidance Documents
  Michael Hagendoorn, Amgen, Inc.; Tim Yerington, Amgen, Inc.
Keywords:  SOP 
Pages: 11 Size: 342 Kb 
tweet!  Writing Efficient Queries in SAS Using PROC SQL with Teradata
  Mina Chen, Roche
Keywords:  Teradata  SQL 
Pages: 5 Size: 117 Kb 
tweet!  Clinical Data Visualization using TIBCO Spotfire® and SAS®
  Ajay Gupta, PPD Inc
Keywords:  TIBCO Spotfire  Excel  SAS 
Pages: 12 Size: 527 Kb 
tweet!  Automating Title and Footnote Extraction Using Visual Basic for Applications (VBA) and SAS"
  Tony Cardozo, Spaulding Clinical
Keywords:  SAS  Visual Basic for Applications  VBA  Title footnote extraction  SAP  Output Shells 
Pages: 12 Size: 155 Kb 
tweet!  Beyond IF THEN ELSE: Techniques for Conditional Execution of SAS® Code
  Josh Horstman, Nested Loop Consulting
Pages: 10 Size: 745 Kb 
Career Planning
tweet!  Creating a Winning Resume Reflecting Your Skills and Experience With Honesty and Integrity.
  Kelly Spak, Chiltern International Ltd.
Keywords:  Resume 
Pages: 3 Size: 34 Kb 
tweet!  The Road Not Often Taken
  Janet Stuelpner, SAS
Pages: 2 Size: 82 Kb 
Best Paper
tweet!  What Makes a Candidate Stand Out?
  Edward Slezinger, Fred Hutchinson Cancer Research Center - SCHARP
Pages: 3 Size: 249 Kb 
tweet!  The Elusive Data Scientist: Real-world analytic competencies
  Greg Nelson, ThotWave
Keywords:  Competencies  analytics  healthcare 
Pages: 14 Size: 928 Kb 
tweet!  Strategies and decisions for marketing yourself as an independent contractor
  Kathy Bradrick, Triangle Biostatistics, LLC
Keywords:  Consulting 
Pages: 3 Size: 53 Kb 
tweet!  The Road Not Taken: SAS for Pharmacometrics
  Vishak Subramoney, Certara Strategic Consulting; Sree Harsha Sreerama Reddy, Certara Strategic Consulting
Keywords:  SAS  Pharmacometrics  CP06  NONMEM  NLME  NCA  PKPD  PK 
Pages: 4 Size: 81 Kb 
tweet!  Becoming a Successful Manager of SAS® Programmers from an Ex-Programmer's Perspective
  Christine Young, Chiltern, International
Pages: 3 Size: 232 Kb 
tweet!  Schoveing Series 3: Living by Knowing When to STOP
  Priscilla Gathoni, AstraZeneca, Statistical Programming
Pages: 13 Size: 211 Kb 
tweet!  Show Me The Job!!!
  Richelle Serrano, Clindata Insight; Kevin Lee, Clindata Insight
Keywords:  Resume 
Pages: 4 Size: 44 Kb 
Data Integrity
tweet!  Real Time Clinical Trial Oversight with SAS
  Ashok Gunuganti, Trevena
Pages: 7 Size: 713 Kb 
tweet!  Let's Check Data Integrity Using Statistical (SAS®) Programmers with SAS®
  Harivardhan Jampala, chiltern international Pvt ltd
Keywords:  Clinical  Data  Integrity  with  SAS 
Pages: 17 Size: 894 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 Change Report
  Eric Kammer, Novartis
Pages: 5 Size: 133 Kb 
tweet!  Clinical and Vendor Database Harmony; Can't we all just get along?
  Brian Armstrong, QST Consultations, Ltd.; Renee Kerwin, QST Consultations, Ltd.
Pages: 9 Size: 299 Kb 
Best Paper
tweet!  Check Your Data: Tools for Automating Data Assessment
  Paul Stutzman, Axio Research
Keywords:  SAS  Data Integrity  PharmaSUG 
Pages: 12 Size: 645 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 
Data Standards
Data Standards Panel
  Susan Kenny, Maximum Likelihood, Inc.; Nate Freimark, The Griesser Group; Sandra Minjoe, Senior ADaM Consultant, Accenture Accelerated R&D Services; Jack Shostak, DCRI; John Troxell, Accenture
  Download the presentationdownload (.pdf, 1050 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 
tweet!  Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples
  Keith Shusterman, Chiltern; Prathima Surabhi, AstraZeneca; Binoy Varghese, MedImmune
Keywords:  CDISC  SDTM  ADaM  Harmonization  Data Standards 
Pages: 6 Size: 350 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!  Ahead of the Curve: Leading with Industry Data Requirements
  Maria Dalton, GlaxoSmithKline; Nancy Haeusser, GlaxoSmithKline
Keywords:  data requirements  data standards 
Pages: 17 Size: 331 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!  Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database
  Cori Kramer, Chiltern International; Ragini Hari, Chiltern International; Keith Shusterman, Chiltern
Keywords:  CDISC  SDTM  Controlled Terminology  Data Standards 
Pages: 7 Size: 56 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!  The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards
  Maggie Ci Jiang, Teva Pharmaceuticals
Keywords:  'CDISC  ADaM  TRACEABILITY 
Pages: 8 Size: 465 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 
Data Visualizations and Graphics
tweet!  Effective Ways to Perfect the Visualization of Clinical Trial Results
  Amos Shu, AstraZeneca
Pages: 6 Size: 1201 Kb 
tweet!  A Combined AE + CM Graph using SAS
  Sanjay Matange, SAS
Keywords:  Adverse Events  Concomitent Medications  SGPLOT Procedure 
Pages: 7 Size: 596 Kb 
tweet!  Multipage Adverse Event Reports Using PROC SGPLOT
  Warren Kuhfeld, SAS; Mary Beth Herring, Rho, Inc.
Keywords:  adverse events  PROC SGPLOT  SAS  ODS Graphics  axis tables  multipage reports 
Pages: 17 Size: 5342 Kb 
tweet!  Mean and Individual Subject Graphs of Concentration vs. Time Data Using PROC SGPLOT
  Pooja Trivedi, Cadila Healthcare Limited
Keywords:  Proc SGPlot  NOGTITLE  BODYTITLE  Line graphs 
Pages: 9 Size: 373 Kb 
tweet!  SAS vs Tableau: Creating Adverse Event/ Concomitant Medication Time line plot
  Liling Wei, Pharmacyclics; Kathy Chen, Pharmacyclics, Inc. A Abbvie Company
Keywords:  Graph  SAS  Tableau  AE  CM  Time  Line  Swimmer's  Plot 
Pages: 6 Size: 349 Kb 
tweet!  Visualizing Enrollment Over Time
  Laura Gruetzner, BioStat Solutions, Inc.
Keywords:  Enrollment  SAS  GTL  Dose Escalation 
Pages: 11 Size: 548 Kb 
tweet!  Using Animated Graphics to Show PKPD Relationships in SAS 9.4
  Andrew Mccarthy, Eli Lilly
Keywords:  PKPD  graphics 
Pages: 8 Size: 21295 Kb 
tweet!  Bird's eye view of the data, a graphical exploration!
  Hrideep Antony, Inventiv Health USA
Keywords:  Bird's eye view  data  graphical exploration  SG Plots  SAS Graphs  Scatter plots  SG Procedures  SGPLOT  SGSCATTER  SGPANEL  MULTIPLE AXIS 
Pages: 9 Size: 605 Kb 
tweet!  Mapping Participants to the Closest Medical Center
  David Franklin, Quintiles Real World Late Phase Research
Keywords:  GMAP 
Pages: 8 Size: 306 Kb 
Best Paper
tweet!  Automated DSMB Presentation in SAS: Yeah, I'd Submit That! How to auto populate PowerPoint presentations so you don't have to
  Brett Jepson, Rho Inc.; Kaitie Lawson, Rho, Inc.
Keywords:  DSMB  ODS PowerPoint  Presentation  Automated 
Pages: 17 Size: 568 Kb 
tweet!  Translating Statistics into Knowledge by Examples Using SAS Graphic Procedures
  Tao Shu, Eli Lilly and Company; Jianfei Jiang, Eli Lilly
Keywords:  graph  statistics 
Pages: 11 Size: 546 Kb 
tweet!  Make it personal: Upgrade your figures by adding individual patient data to the common figure types
  Yuliia Bahatska, inVentiv Health Clinical; Christiane Ahlers, Bayer AG
Keywords:  Figures  individual data  common figure types 
Pages: 20 Size: 638 Kb 
tweet!  The basics of Graphics Template Language and output by PROC DOCUMENT
  Fangping Chen, UBC
Keywords:  ODS  Document 
Pages: 14 Size: 586 Kb 
tweet!  When one is not enough or multi-celled plots: comparison of different approaches
  Vladlen Ivanushkin, inVentiv Health Germany GmbH
Keywords:  multi-celled plots  classification panels  multiple scatter plots  GTL DATAPANEL  SGPANEL  SGSCATTER  GREPLAY 
Pages: 12 Size: 1542 Kb 
tweet!  The %NEWSURV Family of Macros: An Update on the Survival Plotting Macro %NEWSURV and an Introduction to Expansion Macros
  Jeffrey Meyers, Mayo Clinic
Keywords:  Survival  Graphics  Analysis  Macros  Adjusted Survival 
Pages: 21 Size: 966 Kb 
FDA Wednesday
Statistical Review and Data Standards: It’s Gettin’ Better All The Time (slides)
  Steve Wilson, Dr.P.H., CAPT USPHS, Director, Division of Biometrics III, FDA/OMPT
  Download the presentationdownload (.pdf, 3461 Kb)
Update on Data Standards (slides)
  Ron Fitzmartin, PhD, MBA, Sr. Advisor, Office of Strategic Programs, CDER / FDA
  Download the presentationdownload (.pdf, 1940 Kb)
Innovation and Regulatory Review: What is JumpStart? (slides)
  Alan Shapiro, MD, PhD, FAAP, Medical Officer, Office of Computational Sciences, CDER / FDA
  Download the presentationdownload (.pdf, 1748 Kb)
Hands-on Training
tweet!  Five Ways to Create Macro Variables: A Short Introduction to the Macro Language
  Art Carpenter, CA Occidental Consultants
Keywords:  macro 
Pages: 12 Size: 99 Kb 
tweet!  Point-and-Click Programming Using SAS® Enterprise Guide®
  Kirk Paul Lafler, Software Intelligence Corporation; Mira Shapiro, Senior SAS® Consultant, Capacity Planner and SAS Programmer; Ryan Paul Lafler, High School Student and Software Enthusiast
Keywords:  SAS  SAS EG  Enterprise Guide  Point-and-click programming  MS-Excel  data manipulation  system documentation  process flow diagrams  built-in wizards  sas training  sas trainer  sas consulting  sas consultant  sql training  sql trainer  sql consulting  sql consultant  author  sas press  sas press author  Lafler  Kirk Lafler  Kirk Paul Lafler  @sasNerd  Ryan Paul Lafler 
Pages: 18 Size: 2822 Kb 
tweet!  Survival 101 - Just Learning to Survive
  Leanne Goldstein, City of Hope; Rebecca Ottesen, City of Hope
Pages: 20 Size: 933 Kb 
tweet!  New for SAS® 9.4: Including Text and Graphics in Your Microsoft Excel Workbooks, Part 2
  Vince Delgobbo, SAS
Keywords:  ODS  Microsoft Excel  multi-sheet Excel Workbook 
Pages: 26 Size: 1009 Kb 
SAS Studio - the next evolution of SAS programming environments
  Jim Box, SAS Institute
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!  Single File Deliverables: Next Steps
  Bill Coar, Axio Research
Pages: 19 Size: 613 Kb 
SAS® Life Science Visual Analytics
  Pritesh Desai, sas
Healthcare Analytics
tweet!  Developing Your Data Strategy
  Greg Nelson, ThotWave
Keywords:  Data  Strategy 
Pages: 15 Size: 175 Kb 
Best Paper
tweet!  Multinomial Logistic Regression Models With Sas® Proc Surveylogistic
  Marina Komaroff, Noven Pharmaceuticals
Keywords:  Multinomial Logistic Regression  survelogistic 
Pages: 7 Size: 685 Kb 
tweet!  Topology-based Clinical Data Mining for Discovery of Hidden Patterns in Multidimensional Data
  Sergey Glushakov, Intego Group; Iryna Kotenko, Intego Group / Experis Clinical, Site Lead; Andrey Rekalo, Intego Group, Senior Data Scientist
Keywords:  topological data map  clinical trial  multivariate outcome  predictor  data visualization  clinical data mining 
Pages: 20 Size: 1200 Kb 
tweet!  Two Roads Diverged in a Narrow Dataset...When Coarsened Exact Matching is More Appropriate than Propensity Score Matching
  Aran Canes, Cigna
Keywords:  Coarsened  Exact  Matching 
Pages: 7 Size: 292 Kb 
tweet!  Analyzing data from multiple clinical trials using SAS® Real World Evidence
  Jay Paulson, SAS Institute; David Olaleye, SAS Institute
Keywords:  Real  World  Evidence 
Pages: 13 Size: 1580 Kb 
tweet!  Put the "K" in Your KAB: Know How to Efficiently Program with Knowledge, Attitudes, and Behavior Survey Data
  Cara Lacson, United BioSource Corporation; Jasmeen Hirachan, United BioSource Corporation
Keywords:  KAB  Knowledge  Attitudes  Behavior  Survey  REMS 
Pages: 16 Size: 528 Kb 
tweet!  Removing the Mask of Average Treatment Effects in Chronic Lyme Disease Research Using Big Data and Sub-Group Analysis
  Mira Shapiro, Analytic Designers LLC; Lorraine Johnson, LymeDisease.org
Keywords:  Lyme Disease  treatment effects 
Pages: 9 Size: 682 Kb 
tweet!  A Business Solution for Improved Drug Supply Chain Visibility
  David Butler, Teradata Corporation; Joy King, Teradata Corporation; Ronald Chomiuk, Teradata Corporation; Richard Neafus, Teradata Corporation
Pages: 9 Size: 748 Kb 
Industry Basics
tweet!  A Practical Guide to Healthcare Data: Tips, traps and techniques
  Greg Nelson, ThotWave
Keywords:  healthcare  EHR  data quality  data stewardship  patient level data 
Pages: 20 Size: 2247 Kb 
Best Paper
tweet!  Good Programming Practices at Every Level
  Maria Dalton, GlaxoSmithKline
Keywords:  Good Programming Practices  Defensive Programming  Quality 
Pages: 6 Size: 90 Kb 
tweet!  How to define Treatment Emergent Adverse Event (TEAE) in crossover clinical trials
  Mengya Yin, Ultragenyx Pharmaceutical;; Wen Tan, Ultragenyx Pharmaceutical
Keywords:  'Treatment Emergent Adverse Event'  TEAE  Crossover  'Washout Periods'  'Severity Change'  'Partial Dates' 
Pages: 6 Size: 421 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!  Data Monitoring Committee Report Programming: Considering a Risk-Based Approach to Quality Control
  Amber Randall, Axio Research; Bill Coar, Axio Research
Keywords:  Quality control  validation  DMC Report  data monitoring committees 
Pages: 9 Size: 333 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 
Management and Support
tweet!  A Review of "Free" Massive Open Online Content (MOOC) for SAS® Learners
  Kirk Paul Lafler, Software Intelligence Corporation
Keywords:  mooc  massive open online course  massive open online content  sas  worldwide classroom  sas classroom  sas university edition  sas u  support.sas.com  sascommunity  sascommunity.org  youtube  sas youtube channel  author  sas press  sas press author  consultant  sas consultant  consulting  sas consulting  trainer  sas trainer  training  sas training  lafler  kirk lafler  kirk paul lafler  @sasnerd 
Pages: 16 Size: 2215 Kb 
tweet!  The Cross Border Program - Strengthening the Sponsor-Partner Offshore Experience
  Kenneth Bauer, Merck; Girish Havildar, Merck
Keywords:  Offshore  Sponsor-Partner  CRO 
Pages: 5 Size: 149 Kb 
tweet!  Stakeholder Management: How to be an effective lead SAS® programmer
  Aakar Shah, Pfizer
Keywords:  Stakeholder management  Project management  Lead programmer  Stakeholder register 
Pages: 8 Size: 324 Kb 
tweet!  Managing conflicts across Cross Functional and Global Virtual Teams
  Arun Raj Vidhyadharan, inVentiv Health; Sunil Jairath, Inventiv Health
Pages: 8 Size: 116 Kb 
tweet!  Insight into Offsites: creating a productive workflow with remote employees.
  Maddy Wilks, Agility Clinical, Inc
Pages: 4 Size: 194 Kb 
tweet!  Woops, I Didn't Know! An Elegant Solution to Let Your Entire Department Benefit from Individual Lessons Learned
  Michael Hagendoorn, Amgen, Inc.; Annia Way, Amgen, Inc.; Tim Yerington, Amgen, Inc.; Rachel Bowman, Amgen, Inc.
Keywords:  communcation  team development 
Pages: 9 Size: 225 Kb 
tweet!  Mentoring and Oversight of Programmers across Cultures and Time Zones
  Chad Melson, Experis
Keywords:  Mentoring  Internships  Programmer Oversight  Ukraine 
Pages: 7 Size: 145 Kb 
tweet!  Beyond "Just fix it!" Application of Root Cause Analysis Methodology in SAS® Programming.
  Nagadip Rao, Eliassen Group
Keywords:  Root Cause Analysis  RCA  Error  Submission 
Pages: 8 Size: 568 Kb 
Best Paper
tweet!  Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue!
  Gloria Boye, Vita Data Sciences (a division of Softworld, Inc); Aparna Poona, Softworld, Inc. (Life Sciences); Bhavin Busa, Vita Data Sciences (a division of Softworld, Inc.)
Keywords:  Project management  lead programmer 
Pages: 7 Size: 262 Kb 
tweet!  Sponsor Oversight of CROs Data Management and Biostatistical Abilities
  Lois Lynn, Noven Pharmaceuticals, Inc.
Keywords:  Sponsors  CROs  Data Management  Biostatistics 
Pages: 7 Size: 144 Kb 
Posters
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!  Takeaways from Integrating Studies Conducted by Bristol-Myers Squibb (BMS) and ONO
  Yan Wang, Bristol-Myers Squibb
Keywords:  Integrated  Studies 
Pages: 2 Size: 121 Kb 
tweet!  Implementing Patient Report Outcome data in clinical trials analysis
  Qi Wang, Amgen
Pages: 7 Size: 175 Kb 
tweet!  Data Transparency, de-identification strategies, and platforms available for sharing data
  Arun Raj Vidhyadharan, inVentiv Health; Sunil Jairath, Inventiv Health
Pages: 10 Size: 371 Kb 
tweet!  Statistician's secret weapon: 20 ways of detecting raw data issues
  Lixiang Liu, Eli Lilly
Keywords:  data issues 
Pages: 8 Size: 108 Kb 
tweet!  ClinicalTrials.gov Results: an End of Study Deliverable That Should Be Considered at Study Startup
  Maya Barton, Rho; Elizabeth Paynter, Rho
Keywords:  ClinicalTrials.gov  Project Management  Results  Standardization  Macro 
Pages: 9 Size: 135 Kb 
tweet!  In-Licensing from a Programming Perspective
  Asif Karbhari, AstraZeneca
Keywords:  in-licensing  management 
Pages: 5 Size: 78 Kb 
tweet!  AIR Binder: An Automatic Reporting and Data Analysis SAS Application for Cytochrome P450 Inhibition Assay to Investigate DDI
  Hao Sun, Covance, Inc.; Kristen Cardinal, Covance, Inc.; Carole Kirby, Covance, Inc.; Richard Voorman, Covance, Inc.
Keywords:  automation  cytochrome P450 
Pages: 8 Size: 973 Kb 
tweet!  Charting Your Path to Using the "New" SAS® ODS and SG Graphics Successfully - Interactively Generate the Code
  Roger Muller, Data To Events, Inc
Keywords:  graphics  SG graphics  ODS  interactively  generating  code 
Pages: 16 Size: 1010 Kb 
Best Paper
tweet!  Facebook Data Analysis with SAS® Visual Analytics
  Prasoon Sangwan, TATA Consultancy Services Ltd; Vikrant Bisht, TATA Consultancy Services Ltd; Piyush Singh, TCS; Ghiyasuddin Mohammed Faraz Khan, Sapphire Software Solutions Inc.
Keywords:  Facebook  Data  Analysis  using  SAS  Visual  Analytics 
Pages: 10 Size: 1514 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 
Best Paper
tweet!  Mindfulness at Work: Handling Stress and Changes Gracefully and Be the Leader You Were Born To Be
  Helena Ho, Astrazeneca
Keywords:  Management  stress  leadership 
Pages: 7 Size: 360 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 Precision-strike Approach to Submission Readiness: How to Prepare Your Filing Teams for Consistent Excellence
  Michael Hagendoorn, Amgen, Inc.; Tony Chang, Amgen, Inc.
Keywords:  submission 
Pages: 7 Size: 131 Kb 
tweet!  Power of Interleaving and RETAIN Combination in Data Manipulation
  Zongming Pan, ConnectiveRx
Keywords:  Retain  interleaving  data  manipulation 
Pages: 10 Size: 378 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!  Analyzing Singly Imputed Utility Based Weighted Scores Using EQ-5D for Determining Patients' Quality of Life in Oncology Studies
  Vamsi Krishna Medarametla, Seattle Genetics; Liz Thomas, Seattle Genetics; Gokul Vasist, Seattle Genetics
Keywords:  EQ-5D 
Pages: 9 Size: 108 Kb 
tweet!  Dealing with alignment of statistics: Beyond the decimal point.
  Eric Pedraza, INC Research
Keywords:  statistics  formatting 
Pages: 11 Size: 130 Kb 
tweet!  Metadata of Titles, Footnotes, and Proc Report Details
  Julius Kirui, SCRI
Keywords:  formatting  TFL  reporting  titles  footnotes  proc report 
Pages: 11 Size: 594 Kb 
tweet!  SAS and R Playing Nice Together
  David Edwards, Amgen, Inc.; Bella Feng, Amgen, Inc; Brian Schultheiss, Amgen, Inc.
Keywords:  SAS  R 
Pages: 3 Size: 79 Kb 
tweet!  A Guide To Programming Patient Narratives
  Renuka Tammisetti, PRA Health Sciences; Karthika Bhavadas, PRA Health Sciences
Keywords:  patient narratives  ICH-E3 
Pages: 6 Size: 71 Kb 
tweet!  REDCAP Ins and Outs
  Leanne Goldstein, City of Hope
Pages: 10 Size: 866 Kb 
tweet!  Roadmap for Managing Multiple CRO Vendors
  Veena Nataraj, Shire; Karin Lapann, Shire
Keywords:  Standards  management  CRO 
Pages: 7 Size: 445 Kb 
Quick Tips
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!  Importing CSV Data to All Character Variables
  Art Carpenter, CA Occidental Consultants
Keywords:  PROC IMPORT  CSV  Character variables  MIXED= option 
Pages: 5 Size: 258 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 
Best Paper
tweet!  Is There a Date In That Comment? Use SAS To Find Out.
  Keith Hibbetts, Eli Lilly and Company
Keywords:  Perl Regular Expression  dates in text string 
Pages: 4 Size: 153 Kb 
tweet!  My bag of SAS lifehacks
  Dmytro Hasan, Experis
Keywords:  lifehacks 
Pages: 10 Size: 470 Kb 
tweet!  Generating Colors from the Viridis Color Scale with a SAS® Macro
  Shane Rosanbalm, Rho, Inc
Keywords:  vidiris  macro 
Pages: 8 Size: 1046 Kb 
tweet!  PROC DOC III: Self-generating Codebooks Using SAS®
  Louise Hadden, Abt Associates Inc.
Pages: 8 Size: 408 Kb 
tweet!  Basic SDTM House-Keeping
  Emmy Pahmer, inVentiv Health
Keywords:  SDTM checks  CDISC 
Pages: 3 Size: 29 Kb 
tweet!  Everyone can use a little Currency - when dependent data set updates silently make your analysis data set out of date.
  Scott Worrell, PAREXEL
Keywords:  analysis data set currency  QT10 
Pages: 8 Size: 378 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  Laboratory  Domain  Transpose  Proc Transpose 
Pages: 7 Size: 326 Kb 
tweet!  Same statistical method different results? Don't panic the reason might be obvious.
  Iryna Kotenko, Experis Clinical A Manpower Group Company
Keywords:  SAS  SPSS  R  Python  p-value  statistics 
Pages: 8 Size: 399 Kb 
tweet!  Visual Basic for Applications: A Solution for Handling Non-ASCII Removal and Replacement
  Eric Crockett, Chiltern International
Keywords:  Non-ASCII  Excel  VBA  CDISC  ASCII 
Pages: 4 Size: 280 Kb 
tweet!  How to Create a Journal-Quality Forest Plot with SAS® 9.4
  John O'Leary, Department of Veterans Affairs; Warren Kuhfeld, SAS
Keywords:  Forest  Plot 
Pages: 11 Size: 216 Kb 
tweet!  Common mistakes by programmers & Remedies
  Sairam Veeramalla, GCE SOLUTIONS
Keywords:  Common Mistakes  Clinical SAS  Remedies  Clinical programers  TLF mistakes 
Pages: 9 Size: 502 Kb 
Statistics and Pharmacokinetics
Best Paper
tweet!  Multiple Imputation: A Statistical Programming Story
  Chris Smith, Cytel Inc.; Scott Kosten, DataCeutics Inc.
Keywords:  Multiple Imputation  PROC MI  PROC MIANALYZE  FCS  MCMC  MONOTONE  sensitivity analysis  missing data 
Pages: 16 Size: 527 Kb 
tweet!  Multiplicity Controlled Analyses Using SAS/IML
  Xingxing Wu, Eli Lilly and Company; Hangtao Xu, Eli Lilly and Company
Keywords:  Multiplicity Controlled Analyses  Graphical Approach  SAS/IML 
Pages: 8 Size: 339 Kb 
tweet!  Population PK/PD Analysis - SAS® with R and NONMEM® Make Customization Easy
  Sharmeen Reza, Cytel Inc.
Keywords:  PK/PD  Population PK/PD  NONMEM  PK Customization  PD Customization  Population PK/PD Customization 
Pages: 11 Size: 638 Kb 
tweet!  Combining Survival Analysis Results after Multiple Imputation of Censored Event Times
  Jonathan L Moscovici, QuintilesIMS; Bohdana Ratitch, QuintilesIMS
Pages: 11 Size: 758 Kb 
tweet!  Adverse Event Data over Time
  Kriss Harris, SAS Specialists Ltd
Keywords:  Temkin  Graph Template Language  Probability of Being in Best Response Function  PBRF  Adverse Events  TEAE  AE  Treatment Emergent Adverse Events 
Pages: 11 Size: 733 Kb 
Submission Standards
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!  Use of Traceability Chains in Study Data and Metadata for Regulatory Electronic Submission
  Tianshu Li, Celldex
Keywords:  submissions  traceability 
Pages: 8 Size: 515 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 
Best Paper
tweet!  Awareness from Electronic Data Submission to PMDA and FDA -- Lesson & Learnt from hands-on experiences --
  Yuichi Nakajima, Novartis; Takashi Kitahara, Novartis; Ryan Hara, Novartis AG
Keywords:  submissions  pmda  fda 
Pages: 12 Size: 475 Kb 
tweet!  Overview and Application of the HCV Vertical Resistance Analysis Template
  Yan Xie, Abbvie
Keywords:  HCV  Vertical  Resistance 
Pages: 5 Size: 134 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!  Leveraging Study Data Reviewer's Guide (SDRG) in Building FDA's Confidence in Sponsor's Submitted Datasets
  Xiangchen (Bob) Cui, Alkermes, Inc; Min Chen, Alkermes; Letan (Cleo) Lin, Alkermes Inc.
Keywords:  FDA  technical guide  SDRG  reviewers guide 
Pages: 10 Size: 277 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 
Techniques and Tutorials
tweet!  SAS® and ISO8601: A practical approach
  Derek Morgan, PAREXEL
Pages: 10 Size: 133 Kb 
tweet!  Building Intelligent Macros: Using Metadata Functions with the SAS® Macro Language
  Art Carpenter, CA Occidental Consultants
Keywords:  Metadata  macro language  DATA step functions  %SYSFUNC  OPEN  ATTRN  ATTRC  FETCH  CLOSE 
Pages: 17 Size: 478 Kb 
tweet!  SAS® Debugging 101
  Kirk Paul Lafler, Software Intelligence Corporation
Keywords:  SAS  error  errors  warning  warnings  SAS log  log  debug  debugging  sas debugging  sas debugging techniques  Benchworkzz  consultant  sas consultant  sas consulting  sql  sql consultant  sql consulting  author  sas press  sas press author  sas author lafler  sas press author Lafler  trainer  sas trainer  sql trainer  training  sas training  sql training  Lafler  Kirk Lafler  Kirk Paul Lafler  @sasNerd 
Pages: 13 Size: 879 Kb 
tweet!  SAS® Studio: We Program
  Jim Box, SAS Institute
Keywords:  Studio 
Pages: 9 Size: 746 Kb 
tweet!  Special Symbols in Graphs: Multiple Solutions
  Abhinav Srivastva, Gilead Sciences
Keywords:  special symbols in SAS graphs  adding special symbols in SG procedures  methods for including special symbols in graphs 
Pages: 12 Size: 741 Kb 
tweet!  Check Please: An Automated Approach to Log Checking
  Richann Watson, Experis
Keywords:  SAS  LOG 
Pages: 12 Size: 147 Kb 
tweet!  Converting Non-Imputed Dates for SDTM Data Sets With PROC FCMP
  Noory Kim, CROS NT
Keywords:  CDISC 
Pages: 12 Size: 419 Kb 
tweet!  Clinical Trials Data: It's a Scary World Out There! or Code that Helps You Sleep at Night
  Scott Horton, United BioSource
Keywords:  dirty  data 
Pages: 10 Size: 343 Kb 
tweet!  Hashtag #Efficiency! An Exploration of Hash Tables and Other Techniques
  Lakshmi Nirmala Bavirisetty, Independent SAS User; Kaushal Chaudhary, Independent SAS User; Deanna Schreiber-Gregory, Henry M Jackson Foundation for the Advancement of Military Medicine
Keywords:  Hashtables  PROC SQL  Data Step  PharmaSUG 
Pages: 9 Size: 456 Kb 
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Keywords:  Information Loss  Binning  quality 
Pages: 9 Size: 614 Kb 
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Pages: 7 Size: 689 Kb 
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Keywords:  Deming Regression  bootstrap  SAS macro  SQL Procedure 
Pages: 6 Size: 500 Kb 
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Keywords:  Transpose 
Pages: 12 Size: 148 Kb 
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Keywords:  BASE  LOG  PROGRAMMING 
Pages: 7 Size: 175 Kb 
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Keywords:  PharmaSUG  2017 
Pages: 10 Size: 313 Kb 
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Keywords:  validation 
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