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PharmaSUG proceedings: Data Standards and Quality, 93 papers

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

Data Standards
tweet!  Tips and tricks when developing Trial Design Model Specifications that provide Reductions in Creation time
  Ruth Marisol Rivera Barragan, Chiltern International, Inc., Manor, TX
Keywords: TDM Trial Design Model Trial Elements Trial Arms Trial Summary Trial Visit Trial Inclusion UNII SNOMED
Pages: 10 Size: 984 Kb 
tweet!  Results-Level Metadata: What, How, and Why
  Frank Dilorio, CodeCrafters, Inc., Philadelphia PA; Jeffrey Abolafia, Rho Inc., Chapel Hill, NC
Keywords: Metadata Define File Results Metadata ARM end-to-end define.xml Metadata repurposing user interface design
Pages: 11 Size: 322 Kb 
tweet!  Moving up! – SDTM v3.2 – What is new and how to use it
  Alyssa Wittle, Chiltern International, King of Prussia, PA; Christine McNichol, Chiltern International, King of Prussia, PA; Antonio Cardozo, Chiltern International, King of Prussia, PA
Keywords: CDISC SDTM v3.2 IG
Pages: 8 Size: 169 Kb 
tweet!  Getting Started with Data Governance
  Gregory S. Nelson, ThotWave Technologies, Chapel Hill, NC
Pages: 15 Size: 337 Kb 
tweet!  “It is a standard, so it is simple, right?”: Misconceptions and Organizational Challenges of Implementing CDISC at a CRO
  Susan H.M. Boquist, PAREXEL, Billerica, MA; Adam J. Sicard, PAREXEL, Durham, NC
Keywords: CDISC SDTM ADaM SAS
Pages: 5 Size: 290 Kb 
tweet!  Considerations and Conventions within the Therapeutic Area User Guides (TAUGs)
  Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA; Kristin Kelly, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: SDTMIG Therapeutic Area User Guide
Pages: 8 Size: 52 Kb 
Best Paper
tweet!  Deconstructing ADRS: Tumor Response Analysis Data Set
  Steve Almond, Bayer Inc., Toronto, ON, Canada
Keywords: ADRS oncology ADaM tumor response RECIST
Pages: 11 Size: 676 Kb 
tweet!  Prepare for Re-entry: Challenges and Solutions for Handling Re-screened Subjects in SDTM
  Charity Quick, Rho, Inc, Chapel Hill, NC; Paul Nguyen, Rho, Inc, Chapel Hill, NC
Keywords: SDTM Re-screened Re-screening Re-enrolled SUBJID USUBJID CDISC
Pages: 5 Size: 154 Kb 
tweet!  Associated Persons Domains – Who? What? Where? When? Why? How?
  Alyssa Wittle, Chiltern, King of Prussia, PA; Michael Stackhouse, Chiltern, Cary, NC
Pages: 6 Size: 741 Kb 
tweet!  SDTM Trial Summary Domain: Putting Together the TS Puzzle
  Kristin Kelly, Accenture Accelerated R&D Services, Berwyn, PA; Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: SDTM TS Trial Summary CDISC
Pages: 13 Size: 336 Kb 
tweet!  Conformance, Compliance, and Validation: An ADaM Team Lead's Perspective
  John Troxell, Accenture, Berwyn, PA
Keywords: CDISC ADaM Conformance Compliance Validation
Pages: 7 Size: 242 Kb 
tweet!  Implementation of ADaM Basic Data Structure for Cross-over Studies
  Songhui Zhu, A2Z Scientific Inc., East Brunswick, NJ
Keywords: CDISC ADaM BDS Cross-over
Pages: 10 Size: 413 Kb 
tweet!  TRTP and TRTA in BDS Application per CDISC ADaM Standards
  Maggie Ci Jiang, Teva Pharmaceuticals, West Chester, PA
Keywords: CDISC ADaM TRTP TRTA ANL01FL AVISIT APERIOD
Pages: 8 Size: 668 Kb 
tweet!  Transforming Biomarker Data into an SDTM based Dataset
  Kiran Cherukuri, Seattle Genetics, Inc., Bothell, WA
Keywords: Biomarkers SDTM SDTMIG-PGx CDISC
Pages: 7 Size: 302 Kb 
tweet!  Codelists Here, Versions There, Controlled Terminology Everywhere
  Shelley Dunn, Regulus Therapeutics, San Diego, CA
Keywords: Codelists Versions Controlled Terminology
Pages: 12 Size: 689 Kb 

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

Data Standards
tweet!  Understanding SE, TA, TE Domains
  Jacques Lanoue, Novartis Pharmaceuticals Corporation, East Hanover, NJ
Pages: 4 Size: 128 Kb 
tweet!  SDTM TE, TA, and SE Domains: Demystifying the Development of SE
  Kristin Kelly, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA; Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: CDISC
Pages: 6 Size: 271 Kb 
tweet!  Considerations in Conforming Data from Multiple Implantable Medical Devices to CDISC Standards Using SAS®
  Julia Yang, Medtronic plc., Mounds View, MN
Keywords: CDISC
Pages: 9 Size: 184 Kb 
tweet!  ADDL Model for Device Analysis
  Priya Gopal, Theorem Clinical, King of Prussia, PA
Keywords: 'Device Analysis' 'ADDL' ' Metadata'
Pages: 6 Size: 302 Kb 
tweet!  LOCF vs. LOV in Endpoint DTYPE Development with CDISC ADaM Standards
  Maggie Ci Jiang, Teva Pharmaceuticals, West Chester, PA
Keywords: CDISC
Pages: 6 Size: 93 Kb 
tweet!  Considerations in ADaM Occurrence Data: Handling Crossover Records for Non-Typical Analysis
  Karl Miller, inVentiv Health, Lincoln, NE; Richann Watson, Experis, Batavia, OH
Keywords: ADaM OCCDS ANLzzFL CDISC
Pages: 6 Size: 241 Kb 
Best Paper
tweet!  The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future
  Shelley Dunn, d-Wise, Morrisville, NC; Ed Lombardi, Agility Clinical, Carlsbad, CA
Keywords: CDISC
Pages: 9 Size: 521 Kb 
tweet!  Proper Parenting: A Guide in Using ADaM Flag/Criterion Variables and When to Create a Child Dataset
  Richann Watson, Experis, Batavia, OH; Karl Miller, inVentiv Health, Lincoln, NE; Paul Slagle, inVentiv Health, Ann Arbor, MI
Keywords: ADaM BDS ANLzzFL CRITy CRITyFL AVALCATy CDISC
Pages: 10 Size: 411 Kb 
tweet!  ADaM Example for a Complex Efficacy Analysis Dataset
  Milan Mangeshkar, Exelixis, Inc., South San Francisco, CA; Sandra Minjoe, Accenture Life Sciences, San Francisco, CA
Keywords: ADaM efficacy interim intermediate fundamental principles traceability BDS data review analysis-ready flexible CDISC
Pages: 8 Size: 495 Kb 
tweet!  PhUSE De-Identification Working Group: Providing De-Identification Standards to CDISC Data Models
  Jean-Marc Ferran, Qualiance & PhUSE, Copenhagen, Denmark; Jacques Lanoue, Novartis, East Hanover, NJ
Keywords: CDISC
Pages: 8 Size: 407 Kb 
tweet!  It Depends On Your Analysis Need
  Sandra Minjoe, Accenture Life Sciences, San Francisco, CA
Keywords: ADaM fundamental principles BDS ADSL ADAE CSS ADRG FDA Technical Conformance Guide parameters baseline characteristics parameter metadata results metadata
Pages: 10 Size: 392 Kb 
tweet!  DIABETES: Submission Data Standards and Therapeutic End Points
  Naveed M Khaja, SW-T Consulting Group Inc., West Chester, PA
Pages: 9 Size: 369 Kb 
tweet!  Implementing Various Baselines for ADaM BDS datasets
  Songhui Zhu, A2Z Scientific Inc., East Brunswick, NJ
Keywords: CDISC
Pages: 7 Size: 173 Kb 
tweet!  What to Expect in SDTMIG v3.3
  Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: CDISC
Pages: 10 Size: 220 Kb 
tweet!  Considerations in Submitting Non-Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain
  Jerry Salyers, Accenture Accelerated R&D Services, Berwyn, PA; Richard Lewis, Accenture Accelerated R&D Services, Berwyn, PA; Fred Wood, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: SDTM Supplemental Qualifiers Findings About Interventions Events
Pages: 6 Size: 62 Kb 
tweet!  What is the “ADAM OTHER” Class of Datasets, and When Should it be Used?
  John Troxell, Accenture Accelerated R&D Services, Berwyn, PA
Keywords: CDISC
Pages: 5 Size: 327 Kb 
ADaM Implementation Roundtable Discussion
  Nancy Brucken, inVentiv Health Clinical; Richann Watson, Experis; Steve Kirby, Theorem Clinical Research
Keywords: CDISC
tweet!  Managing Custom Data Standards in SAS® Clinical Data Integration
  Melissa R. Martinez, SAS
Keywords: SAS CDI SSD Drug Development CDISC Data Standards Clinical Data Integration
Pages: 17 Size: 374 Kb 

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

Data Standards
tweet!  Discover Define-XML
  Mark Wheeldon, Formedix, Burlington, MA; Kevin Burges, Formedix, Burlington, MA
Keywords: xml
Pages: 12 Size: 1411 Kb 
tweet!  Forging New SDTM Standards for In-Vitro Diagnostic (IVD) Devices: A Use-Case
  Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA; Smitha Krishnamurthy, Roche Molecular Systems, Inc., Pleasanton, CA; Mansi Singh, Roche Molecular Systems, Inc., Pleasanton, CA; Sy Truong, Meta-Xceed, Inc., Fremont, CA
Keywords: CDISC
Pages: 6 Size: 148 Kb 
tweet!  Considerations in Creating SDTM Trial Design Datasets
  Jerry Salyers, Accenture Life Sciences, Berwyn, PA; Richard Lewis, Accenture Life Sciences, Berwyn, PA; Kim Minkalis, Accenture Life Sciences, Berwyn, PA; Fred Wood, Accenture Life Sciences, Berwyn, PA
Keywords: SDTM Trial Design Model Datasets CDISC
Pages: 9 Size: 159 Kb 
tweet!  Considerations in the Submission of Exposure Data in SDTM-Based Datasets
  Fred Wood, Accenture Life Sciences, Wayne, PA; Jerry Salyers, Accenture Life Sciences, Wayne, PA; Richard Lewis, Accenture Life Sciences, Wayne, PA; Kristin Kelly, Accenture Life Sciences, Wayne, PA
Keywords: CDISC
Pages: 6 Size: 48 Kb 
tweet!  Data Standards Development for Therapeutic Areas: A Focus on SDTM-Based Datasets
  Fred Wood, Accenture Life Sciences, Wayne, PA; Diane Wold, Glaxo SmithKline, Research Triangle Park, NC; Rhonda Facile, CDISC, Austin, TX; Wayne Kubick, CDISC
Keywords: CDISC
Pages: 10 Size: 235 Kb 
tweet!  Referencing Medical Device Data in Standard SDTM domains
  Timothy L Bullock, Allergan, Santa Barbara, CA; Ramkumar Krishnamurthy, Allergan, Santa Barbara, CA
Keywords: SDTM Device FA Findings About Procedure CDISC
Pages: 7 Size: 497 Kb 
tweet!  Applying ADaM BDS Standards to Therapeutic Area Ophthalmology
  Songhui Zhu, A2Z Scientific Inc., East Brunswick, NJ
Keywords: CDISC
Pages: 10 Size: 227 Kb 
tweet!  Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS
  Karin LaPann, PRA International, Horsham, PA; Terek Peterson, MBA, PRA International, Horsham, PA
Keywords: Questionnaire ADQS QS ADaM SDTM CDISC Conversions
Pages: 20 Size: 795 Kb 
tweet!  An ADaM Interim Dataset for Time-to-Event Analysis Needs
  Tom Santopoli, Accenture, Berwyn, PA; Kim Minkalis, Accenture, Berwyn, PA; Sandra Minjoe, Accenture, Berwyn, PA
Keywords: CDISC
Pages: 9 Size: 85 Kb 
tweet!  Developing ADaM Specifications to Embrace Define-XML 2.0.0 Requirements
  Lin Yan, Celgene Corporation, 300 Connell Drive, Berkeley Heights, NJ
Keywords: CDISC xml
Pages: 10 Size: 366 Kb 
tweet!  A Guide to the ADaM Basic Data Structure for Dataset Designers
  Michelle Barrick, Eli Lilly and Company, Indianapolis, IN; John Troxell, John Troxell Consulting LLC, Bridgewater, NJ
Keywords: CDISC ADaM BDS
Pages: 12 Size: 311 Kb 
tweet!  Effective Use of Metadata in Analysis Reporting
  Jeffrey Abolafia, Rho Inc., Chapel Hill, NC
Keywords: Metadata Define File Results
Pages: 9 Size: 393 Kb 
Best Paper
tweet!  How Valued is Value Level Metadata?
  Shelley Dunn, d-Wise, Morrisville, NC
Pages: 12 Size: 408 Kb 
Best Paper
tweet!  CDISC Electronic Submission
  Kevin Lee, Accenture Life Sciences, Berwyn, PA
Keywords: CDISC
Pages: 6 Size: 270 Kb 
tweet!  A Road Map to Successful CDISC ADaM Submission to FDA: Guidelines, Best Practices & Case Studies
  Vikash Jain, Accenture Life Sciences, Berwyn, PA; Sandra Minjoe, Accenture Life Sciences, Berwyn, PA
Keywords: CDISC
Pages: 9 Size: 587 Kb 
tweet!  OpenCDISC Validator Implementation: A Complex Multiple Stakeholder Process
  Terek Peterson, MBA, PRA International, Horsham, PA; Gareth Adams, PRA International, Swansea, United Kingdom
Keywords: CDISC
Pages: 9 Size: 285 Kb 
tweet!  Update: Development of White Papers and Standard Scripts for Analysis and Programming
  Nancy Brucken, inVentiv Health Clinical, Ann Arbor, MI; Michael Carniello, Takeda Development Center Americas, Inc., Deerfield, IL; Mary Nilsson, Eli Lilly and Company, Indianapolis, IN; Hanming Tu, Accenture, Wayne, PA
Keywords: CSS Working Group standard scripts
Pages: 3 Size: 34 Kb 
tweet!  An Alternative Way to Create Define.XML for ADaM with SAS Macro Automation
  Yiwen Li, Gilead Sciences, Foster City, CA
Keywords: CDISC macro xml
Pages: 4 Size: 51 Kb 
tweet!  SAS® as a Tool to Manage Growing SDTM+ Repository for Medical Device Studies
  Julia Yang, Medtronic Inc. Mounds View, MN
Keywords: CDISC
Pages: 12 Size: 715 Kb 
A How-To Guide for Extending Controlled Terminology Using SAS Clinical Data Integration
  Melissa Martinez, SAS Institute, Cary, NC
tweet!  Round Trip Ticket – Using the Define.xml file to Send and Receive your Study Specifications
  Julie Maddox, SAS Institute Inc., Cary, NC
Keywords: CRT-DDS DEFINE.XML SAS Clinical Data Integration SAS Clinical Standards Toolkit SAS Clinical Data Integration CDISC
Pages: 10 Size: 399 Kb    Download the Super Demodownload (.pdf, 1061 Kb)
An Integrated platform to manage Clinical data, Metadata and Data Standards
  Romain Rutten, Janssen Research and Development; Peter Wang, Janssen Research and Development; Sharon Trevoy, SAS Institute, Cary, NC
tweet!  Creating Define-XML version 2 with the SAS® Clinical Standards Toolkit 1.6
  Lex Jansen, SAS Institute Inc., Cary, NC
Keywords: SAS CST CDISC CRT-DDS Define-XML define.xml metadata
Pages: 33 Size: 1331 Kb    Download the presentationdownload (.pdf, 1404 Kb)   Download the Super Demodownload (.pdf, 808 Kb)

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

Data Standards
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 
tweet!  Experiences in Preparing Summary Level Clinical Site Data within NDA’s Submission for FDA’s Inspection Planning
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA
Pages: 19 Size: 178 Kb 
Best Paper
tweet!  Considerations in the Use of Timing Variables in Submitting SDTM-Compliant Datasets
  Jerry Salyers, Accenture Life Sciences, Wayne, PA; Richard Lewis, Accenture Life Sciences, Wayne, PA; Fred Wood, Accenture Life Sciences, Wayne, PA
Keywords: SDTM Study Reference Period Timing variable Relative time point variable nominal time point CDISC
Pages: 6 Size: 132 Kb 
tweet!  Good vs Better SDTM: Limitations as Operational Model
  Henry B. Winsor, Affymax, Inc, Palo Alto, CA; Mario Widel, Roche Molecular Systems, Inc., Pleasanton, CA
Keywords: CDISC SDTM Operational Model
Pages: 4 Size: 129 Kb 
tweet!  Mapping Unique Aspects of Implantable Medical Device Study Data to CDISC SDTM Medical Device Domains
  Timothy L Bullock, Allergan Medical, Santa Barbara, CA; Sini Nair, Allergan Medical, Santa Barbara, CA; Ramkumar Krishnamurthy, Allergan Medical, Santa Barbara, CA; Todd M Gross, Allergan Medical, Santa Barbara, CA
Keywords: SDTM Device Implant CDISC
Pages: 12 Size: 435 Kb 
tweet!  Considerations in Data Modeling when Creating Supplemental Qualifiers Datasets in SDTM-Based Submissions
  Fred Wood, Accenture Life Sciences, Wayne, PA
Keywords: CDISC
Pages: 12 Size: 258 Kb 
tweet!  Some Strategies for Validating Your Data before Submission
  Frank Roediger, SAS Institute, Cary, NC; Sandeep Juneja, SAS Institute, Cary, NC
Keywords: Character Field Length SDTM Warehouse V5 Transport File Clinical Standards Toolkit CST
Pages: 8 Size: 539 Kb 
tweet!  Assessing Drug Safety with Bayesian Hierarchical Modeling Using PROC MCMC and JMP
  Doug Robinson, SAS Institute, Inc., Cary, NC
Pages: 1 Size: 234 Kb 

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

Data Standards and Quality
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!  Ir-RECIST-ible
  Sanket Kale, Parexel International, Durham, NC; Jeffrey Moran, Parexel International, Durham, NC
Keywords: RECIST LESIONS
Pages: 4 Size: 123 Kb 
tweet!  SAS File Design: Guidelines for Statisticians and Data Managers
  Douglas Zirbel, Independent Consultant, St Louis, MO
Keywords: file design database cdisc normalization normal form checklist
Pages: 6 Size: 304 Kb 
tweet!  Seven New SDTM Domains for Medical Devices
  Carey Smoak, Roche Molecular Systems, Inc., Pleasanton, CA; Fred Wood, Octagon Research Solutions, Wayne, PA; Rhonda Facile, CDISC, TX; Kit Howard, Kestrel Consultants, MI
Keywords: CDISC Medical Devices SDTM
Pages: 4 Size: 103 Kb 
tweet!  SDTM Domain Mapping with Structured Programming Methodology
  Chengxin Li, Boehringer Ingelheim, Ridgefield, CT; Jing-Wei Gao, Boehringer Ingelheim, Ridgefield, CT; Nancy Bauer, Boehringer Ingelheim, Ridgefield, CT
Keywords: SDTM Domain Mapping Structured Programming CDISC
Pages: 8 Size: 735 Kb 
tweet!  Generating SUPPQUAL Domains From SDTM-Plus Domains
  John R. Gerlach, TAKE Solutions, Inc., Princeton, NJ; Glenn O'Brien, Independent Consultant, Roseland, NJ
Keywords: CDISC SUPPQUAL SDTM-Plus
Pages: 6 Size: 192 Kb 
tweet!  Avoiding a REL-WRECK; Using RELREC Well
  Karl Miller, Pharmanet-i3, Lincoln, NE; J.J. Hantsch, Pharmanet-i3, Chicago, IL; Janet Stuelpner, SAS Institute Inc., New Canaan, CT
Pages: 6 Size: 64 Kb 
tweet!  Considerations in the Submission of Exposure Data in an SDTM-Compliant Format
  Fred Wood, Octagon Research Solutions, Wayne, PA; Jerry Salyers, Octagon Research Solutions, Wayne, PA; Richard Lewis, Octagon Research Solutions, Wayne, PA
Keywords: CDISC
Pages: 4 Size: 39 Kb 
tweet!  Considerations in the Submission of Pharmacokinetics (PK) Data in an SDTM-Compliant Format
  Fred Wood, Octagon Research Solutions, Wayne, PA; Peter Schaefer, Certara, Cary, NC; Richard Lewis, Octagon Research Solutions, Wayne, PA
Keywords: CDISC
Pages: 8 Size: 134 Kb 
tweet!  Experiences in Leading a Company-Wide First CDISC Filing from a Programming Perspective
  Sho-Rong Lee, Genentech, a Member of the Roche Group, South San Francisco, CA
Keywords: CDISC
Pages: 6 Size: 214 Kb 
tweet!  “Analysis-ready” – Considerations, Implementations, and Real World Applications
  Ellen (Zihui) Lin, Amgen Inc, Thousand Oaks, CA; Beiying Ding, Amgen Inc, Thousand Oaks, CA
Pages: 6 Size: 273 Kb 
tweet!  A Complex ADaM dataset? Three different ways to create one.
  Kevin Lee, Cytel, Inc., Chesterbrook, PA
Keywords: A complex ADaM dataset ADaM+ SDTM SDTM+ Intermediate ADaM dataset CDISC
Pages: 11 Size: 191 Kb 
tweet!  Building Flexible ADaM Analysis Variable Metadata
  Songhui Zhu, K & L Consulting Services, Fort Washington, PA; Lin Yan, Celgene Corporation, Summit, NJ
Keywords: CDISC
Pages: 10 Size: 193 Kb 
Best Paper
tweet!  Common Misunderstandings about ADaM Implementation
  Nate Freimark, Theorem Clinical Research, King of Prussia, PA; Susan Kenny, Amgen Inc, Thousand Oaks, CA; Jack Shostak, Duke Clinical Research Institute, Durham, NC; John Troxell, John Troxell Consulting LLC, Bridgewater, NJ
Keywords: ADaM ADaMIG CDISC FDA
Pages: 10 Size: 98 Kb 
tweet!  Creating an Integrated Summary of Safety Database using CDISC ADaM : Challenges, Tips and Things to Watch Out
  Rajkumar Sharma, Genentech Inc., A member of the Roche Group, South San Francisco, CA
Keywords: CDISC
Pages: 7 Size: 76 Kb 
tweet!  CDISC ADaM Application: Does All One-Record-per-Subject Data Belong in ADSL?
  Sandra Minjoe, Octagon Research Solutions, Wayne, PA
Keywords: CDISC ADaM one-record-per-subject ADSL BDS baseline characteristics FDA CDER reviewer traceability per-protocol derived parameter analysis parameter multivariate analysis transpose
Pages: 10 Size: 409 Kb 
tweet!  Multiple Applications of ADaM Time-to-Event Datasets
  Huei-Ling Chen, Merck Sharp & Dohme Corp., Whitehouse Station, NJ; Helen Wang, Merck Sharp & Dohme Corp., Whitehouse Station, NJ
Keywords: CDISC
Pages: 6 Size: 40 Kb 
tweet!  An Innovative ADaM Programming Tool for FDA Submission
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Min Chen, Vertex Pharmaceuticals, Cambridge, MA; Tathabbai Pakalapati, Vertex Pharmaceuticals, Cambridge, MA
Keywords: CDISC ADaM FDA Submission Innovative Automation Compliance Checking Version Control Tracking Changes Consistency Checking Empty Variable Checking define.xml
Pages: 25 Size: 372 Kb 
tweet!  Creating Analysis Data Marts from SDTM Warehouses
  Frank L. Roediger, SAS Institute, Inc., Cary, North Carolina
Keywords: SDTM Data Warehouse Data Mart Oceans Pools, CDISC
Pages: 9 Size: 481 Kb 
tweet!  Harnessing the Power of SAS ISO 8601 Informats, Formats, and the CALL IS8601_CONVERT Routine
  Kim Wilson, SAS Institute Inc., Cary, NC, USA
Pages: 15 Size: 82 Kb 
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