SAS proceedings: CDISC

SCSUG 2011

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

SESUG 2011

 Validating Controlled Terminology in SDTM Domains
  John Gerlach
Size: 592 Kb 

 Proc CDISC: Implementation and Assessments
  Sheetal Nisal and Shilpa Edupganti
Size: 71 Kb 

WUSS 2011

 How to easily convert clinical data to CDISC SDTM
  Ale Gicqueau, Clinovo
Size: 380 Kb 

 Use CDISC SDTM as a data middle-tier to streamline your SAS® infrastructure
  Kalyani Chilukuri, clinovo
Size: 1004 Kb 

 Clinical Data Review on iPad® with DEFINE.XML
  Sy Truong, Meta-Xceed, Inc.
Size: 1161 Kb 

PhUSE 2011

 ADaM Validation and Integrity Checks
  Louise Cross, ICON Clinical Research
Size: 114 Kb 
     Download the presentation (1200 Kb)

 SDTM Implementation Guide - Clear as Mud: Strategies for Developing Consistent Company Standards
  Brian Mabe, UCB BioSciences Inc
Size: 253 Kb Keywords:  CDISC
     Download the presentation (928 Kb)

 Three Unique Case Studies - On the Trail of the Holy Grail of SDTM Implementation
  Kenneth Stoltzfus, Octagon Research Solutions
Size: 82 Kb Keywords:  CDISC, SDTM, mapping, implementation, governance
     Download the presentation (1651 Kb)

 Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies - an ICON Approach
  Jennie McGuirk and Steven Thacker, ICON Clinical Research
Size: 453 Kb Keywords:  CDISC
     Download the presentation (1579 Kb)

 SDTM Domain QS: Challenges and Pitfalls - an Interpretation Guide to the Implementation Guide
  Knut Mueller, UCB BioSciences
Size: 100 Kb Keywords:  CDISC
     Download the presentation (2930 Kb)

 Using the SAS® Clinical Standards Toolkit to work with the CDISC ODM model
  Lex Jansen, SAS Institute Inc
Size: 627 Kb Keywords:  SAS, CDISC, ODM, XML, SAS® Clinical Standards Toolkit
     Download the presentation (3529 Kb)

 SAS Drug Development as a platform governing data standards specification and clinical data exchange
  Mark Lambrecht, SAS and Peter Van Reusel, Business & Decision Life Sciences
Size: 402 Kb Keywords:  SAS Drug Development standards CDISC workflow library, clinical

Tracing data elements through a standard data flow
  Alistair Dootson, Dootsonic

     Download the presentation (1537 Kb)

 Defining the Governance and Process of Implementing ADaM across an Organization
  Chris Decker, d-Wise Technologies
Size: 298 Kb 
     Download the presentation (1591 Kb)

 Creating ADaM Friendly Analysis Data from SDTM Using Meta Data
  Erik Brun and Rico Schiller, H. Lundbeck A/S
Size: 527 Kb Keywords:  CDISC, ADaM, SDTM, analysis datasets, metadata generated
     Download the presentation (1748 Kb)

 ADaM on a diet: preventing wide and heavy analysis datasets
  Dirk Van Krunckelsven, Merck Serono International S.A
Size: 191 Kb Keywords:  ADaM CDISC Wide ADSLSUPP BDSL
     Download the presentation (728 Kb)

A SAS macro to check SDTM domains against controlled terminology
  Guido Wendland, UCB Biosciences GmbH
Keywords:  CDISC, macro
     Download the presentation (3063 Kb)

Much ADaM about Nothing - a PROC Away in a Day
  Endri Endri and Rowland Hale i3

     Download the presentation (10553 Kb)

 JMP Clinical for the Exploration of Legacy Vaccine Trials
  Robert Eric Huisden, OCS Biometric Support
Size: 92 Kb Keywords:  clinical
     Download the presentation (554 Kb)

 Rebuilding define.pdf by reading Word and XFDF files
  David Garbutt, BIOP AG
Size: 1773 Kb Keywords:  SAS, V9.2, unicode, XML map, XML engine, FDA, Data Definition Document
     Download the presentation (2168 Kb)

 Extension of the Six Steps Approach: How to go from an SDTM finding domain to an ADaM-compliant AD
  Carl Herremans and Qian Wang, Merck Sharpe & Dohme (Europe)
Size: 179 Kb Keywords:  CDISC
     Download the presentation (140 Kb)

 FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards
  Peter Van Reusel and Tina Apers, Business & Decision Life Sciences
Size: 115 Kb Keywords:  FDACDISC SDTMsubmission
     Download the presentation (2839 Kb)

Understanding NDA/BLA Clinical Data Submission
  Dirk Spruck, Accovion
Keywords:  clinical
     Download the presentation (1020 Kb)

 Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata
  Philippe Verplancke, XClinical GmbH
Size: 1409 Kb Keywords:  CDISC, xml
     Download the presentation (1409 Kb)

 "Overnight" Conversion to SDTM Datasets - Ready for SDTM Submission
  Niels Mathiesen, Mathiesen & Mathiesen
Size: 1780 Kb Keywords:  CDISC
     Download the presentation (2535 Kb)

 SAS Clinical Data Integration
  Bill Gibson, SAS
Size: 64 Kb Keywords:  clinical

 Implementation of CDISC standards supported by global mapping process and metadata library
  Dimitri Kutsenko, Entimo AG
Size: 119 Kb Keywords:  CDISC
     Download the presentation (1272 Kb)

 Implementing ADaM Using the SAS® Clinical Standards Toolkit
  Gene Lightfoot, SAS Institute Inc
Size: 674 Kb Keywords:  clinical
     Download the presentation (2339 Kb)

MWSUG 2011

 How to Use SDTM Definition and ADaM Specifications Documents to Facilitate SAS Programming
  Yan Liu, Sanofi Pasteur, Beijing, China
Size: 291 Kb 

 Is It Time to Upgrade CDISC SDTM from v1.1/v3.1.1 to v1.2/v3.1.2?
  Susan M. Fehrer, BioClin, Inc., Emporia, KS
Size: 133 Kb 

 Creating a Clean Multi-Tabbed SDTM Dataset Specification Spreadsheet
  Dongju Liu, Advanced Clinical, Deerfield, IL; William Conover, Advanced Clinical, Deerfield, IL
Size: 434 Kb 

NESUG 2011

 A Validation Macro to Check Compliance of CDISC SDTM Data
  Hany Aboutaleb, Biogen Idec
Size: 375 Kb Keywords:  macro

 Automating SDTM File Creation: Metadata Files Speeding the Process
  Daphne E. Ewing, Auxilium Pharmaceuticals Inc.
Size: 100 Kb 

 Validating CDISC Compliant Data and Creating Define.xml Made Easy
  Sandeep Purwar, Bodhi Global Solutions
Size: 685 Kb Keywords:  xml

 A Fast Programming Channel from DDT to Datasets in Pharmaceutical Industries
  Jianfeng Wang, Sanofi Pasteur; Linghua Zhou, Sanofi Pasteur
Size: 152 Kb 

 Generating Define.xml
  Sandeep Kottam, Ockham; Uma Sarath Annapareddy, INDEPENDENT CONSULTANT; Sree Lakshmi K Tripuraneni, PURDUE PHARMA
Size: 836 Kb Keywords:  xml

PharmaSUG 2011

 An Excel Framework to Convert Clinical Data to CDISC SDTM Leveraging SAS Technology
  Sophie McCallum, Clinovo, Sunnyvale CA; Stephen Chan, Clinovo, Sunnyvale, CA
Size: 1217 Kb Keywords:  CDISC, Microsoft Excel, Regulatory Submissions

 Creating a define.xml file for ADaM and SDTM
  John H. Adams, Boehringer Ingelheim Pharmaceutical, Inc., Ridgefield, CT
Size: 796 Kb Keywords:  Define XML ADaM SDTM schema stylesheet, CDISC

 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
Size: 505 Kb Keywords:  CDISC, Clinical Trials, Macros, Microsoft Excel, Regulatory Submissions, XML

 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
Size: 288 Kb Keywords:  CDISC, Clinical Trials, Macros, Microsoft Excel, Regulatory Submissions, XML

 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
Size: 356 Kb Keywords:  CDISC SDTMIG 3.1.1 3.1.2 Data Management Reporting

 Methods of Building Traceability for ADaM Data
  Songhui Zhu, K & L Consultant Services, Fort Washington, PA; Lin Yan, Celgene Corp, Basking Ridge, NJ
Size: 103 Kb Keywords:  ADaM, ADQS, Traceability

 Validating Controlled Terminology in SDTM Domains
  John R. Gerlach, SAS / CDISC Analyst; Hamilton, NJ
Size: 98 Kb Keywords:  Regulatory Submissions, OpenCDISC, CDISC, Controlled Terminology

 Resolving OpenCDISC Error Messages Using SAS®
  Virginia Redner, Merck & Company, Inc., Upper Gwynedd, PA; John R. Gerlach, SAS / CDISC Analyst; Hamilton, NJ
Size: 112 Kb Keywords:  OpenCDISC, CDISC, SQL, Validation

 A Special SDTM Domain RELREC and its Application
  Changhong Shi, Merck Sharpe & Dohme Corp., Rahway, NJ; Beilei Xu, Merck Sharpe & Dohme Corp., Rahway, NJ
Size: 35 Kb Keywords:  CDISC

 Basic Understanding on SE Domain for Beginners
  Gayatri Karkera, i3 Statprobe (Ingenix Pharmaceutical Services), Mumbai, India
Size: 174 Kb Keywords:  CDISC

 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
Size: 51 Kb Keywords:  CDISC,ADaM, SDTM

 CDISC Variable Mapping and Control Terminology Implementation Made Easy
  Balaji Ayyappan, Ockham Group, Cary, NC; Manohar Sure, Ockham Group, Cary, NC
Size: 208 Kb Keywords:  CDISC

 ADaM Standard Naming Conventions are Good to Have
  Christine Teng, Merck Sharp & Dohme Corp, Rahway, NJ
Size: 71 Kb Keywords:  CDISC, ADaM, ExcelXP, Naming Convention, Regular Expressions

 Trials and Tribulations of SDTM Trial Design
  Fred Wood, Octagon Research Solutions, Wayne, PA; Mary Lenzen, Octagon Research Solutions, Wayne, PA
Size: 64 Kb Keywords:  CDISC

 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
Size: 203 Kb 

 Validating define.xml: Tools, trials, and tribulations
  Sandra VanPelt Nguyen, i3 Statprobe
Size: 42 Kb Keywords:  CDISC, define.xml, validation, schema

 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
Size: 72 Kb Keywords:  CDISC, ADaM, Macros, SAS® programming validation, analysis data specification

 A Regular Language: The Annotated Case Report Form
  Ryan Wilkins, PPD, Inc., Wilmington, NC; Joel Campbell, PPD, Inc., Wilmington, NC
Size: 94 Kb Keywords:  CDISC, DEFINE.XML, Annotated CRF, aCRF, Adobe Acrobat, xFDF, BNF, parse, SAS Regular Expression, regular language

 Challenges in Implementing ADaM datasets: Balancing the Analysis-Ready and Traceability Concepts
  Pushpa Saranadasa, Merck & Co., Inc.
Size: 125 Kb 

 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
Size: 48 Kb Keywords:  CDISC

 Ensuring Consistent Data Mapping Across SDTM-based Studies – a Data Warehouse Approach
  Annie Guo, ICON Clinical Research, North Wales, PA
Size: 437 Kb Keywords:  SDTM Mapping Clinical Trial Annotations CRF, CDISC, warehouse

 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
Size: 67 Kb Keywords:  CDISC, SDTM, ADaM, pitfalls

 Good Versus Better SDTM -- Date and Time Variables
  Mario Widel, Roche Molecular Systems, Inc., Pleasanton, CA; Henry B. Winsor, WinsorWorks, Limited, San Mateo, CA
Size: 56 Kb Keywords:  CDISC, SDTM, Date and Timing Variables

 Producing Clinical Laboratory Shift Tables From ADaM Data
  Rao Bingi, Octagon Research Solutions, Wayne, PA
Size: 385 Kb Keywords:  lab shift table, shift table, SAS, ADaM, shift tables, proc freq, Rao Bingi, Bingi, proc sql

 Creating SDTM Datasets from Legacy Data
  Fred Wood, Octagon Research Solutions, Wayne, PA
Size: 122 Kb Keywords:  CDISC

 From SAP to BDS: The Nuts and Bolts
  Nancy Brucken, i3 Statprobe, Ann Arbor, MI; Paul Slagle, United BioSource Corp., Ann Arbor, MI
Size: 161 Kb Keywords:  ADaM, CDISC, BDS, Basic Data Structure
     Download the workshop files (7423 Kb)

 SDTM, ADaM and define.xml with OpenCDISC®
  Matt Becker, PharmaNet, Cary, NC; Angela Ringelberg, PharmaNet, Cary, NC
Size: 5002 Kb Keywords:  CDISC, xml

 Brave New World: How to Adapt to the CDISC Statistical Computing Environment
  Jeff Abolafia, Rho, Inc., Chapel Hill NC; Frank DiIorio, CodeCrafters, Inc., Philadelphia PA
Size: 259 Kb Keywords:  CDISC; ADaM; SDTM; DASH; ADaM model; SDTM model; metadata; workflow; standards; standards implementation; statistical computing

 Method to Derive Reproducible SDTM Relationship Datasets
  Suwen Li, Everest Research Services Inc., Markham, ON; Sai Ma, Everest Research Services Inc., Markham, ON; Regan Li, Everest Research Services Inc., Markham, ON; Bob Lan, Everest Research Services Inc., Markham, ON
Size: 181 Kb Keywords:  CDISC

 Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You’re Sorry When Creating SDTM Domains
  Janet Stuelpner, SAS Institute, Inc.; Jack Shostak, Duke Clinical Research Institute
Size: 1764 Kb Keywords:  CDISC

 Using the SAS® Clinical Standards Toolkit for define.xml creation
  Lex Jansen, SAS Institute Inc., Cary, NC
Size: 706 Kb Keywords:  define.xml, CDISC, SDTM, SAS
     Download the presentation (1721 Kb)

 New Tips and Tricks for Creating a Harmonized, Report-Friendly SDTM and ADaM Lab Data for a Clinical Study Report
  Xiangchen (Bob) Cui, Vertex Pharmaceuticals, Cambridge, MA; Min Chen, Vertex Pharmaceuticals, Cambridge, MA; Scott Moseley, Vertex Pharmaceuticals, Cambridge, MA
Size: 109 Kb Keywords:  LB SDTM, ADLB ADaM, CDISC compliant, Regulatory Submissions

 Using the ADaM Basic Data Structure for Survival Analysis
  Nancy Brucken, i3 Statprobe, Ann Arbor, MI; Sandra Minjoe, Octagon Research, Wayne, PA; Mario Widel, Roche Molecular Systems, Pleasanton, CA
Size: 48 Kb Keywords:  ADaM, BDS, survival analysis, TTE, time to event, CDISC, basic data structure

SAS Global Forum 2011

 Driving Clinical Safety Reviews with Data Standards
  Geoffrey A. Mann
Size: 422 Kb Keywords:  clinical ,

 State of the Union: The Crossroads of CDISC Standards and SAS’ Supporting Role
  Michael Molter, Chris Decker
Size: 430 Kb 

 Confessions of a Clinical Programmer: Dragging and Dropping Means Never Having to Say You’re Sorry When Creating SDTM Domains
  Janet Stuelpner, Jack Shostak
Size: 908 Kb Keywords:  clinical ,

 How to Build ADaM Basic Data Structure from Mock Up Table
  Kevin Lee
Size: 77 Kb 

 Using SAS® to Incorporate the SDTM for a Study Funded by the NIH
  Fenghsiu Su, Bradford Jackson, Kaming Lo, Sumihiro Suzuki, Karan Singh, David Coultas
Size: 100 Kb 

 What CDISC Means to SAS® Programmers
  Kevin Lee
Size: 53 Kb 

NESUG 2010

 Outsourced Data Integration Project with CDISC SDTM and ADaM Deliverables
  Margaret M. Coughlin, Merck & Co., Inc.; Christine Teng, Merck Research Laboratories
Size: 187 Kb 

 Automating SDTM File Creation: Metadata Files Speeding the Process
  Daphne Ewing, Auxilium Pharmaceuticals, Inc.
Size: 87 Kb Keywords:  sponsor=AUXILIUM

 SAS and open source tools for CDISC SDTM compliance checks for regulatory submissions
  Sandeep Kottam, Eisai Pharmaceuticals; Peter Loonan, Smith Hanley Consulting; Sree Lakshmi Kalyani Tripuraneni, Contractor at Purdue Pharma
Size: 326 Kb 

 The 5 Biggest Challenges of ADaM
  Terek Peterson, Octagon Research Solutions; David C. Izard, Shire
Size: 130 Kb 

 Date Conversions in SDTM and ADaM Datasets
  Lily Zhang, Merck Sharp & Dohme Corp.; Lili Chen, Merck & Co.; Huei-Ling Chen, Merck & Co., Inc.
Size: 68 Kb 

 The Past, Present, and Future of Clinical Data Standards
  Chris Decker, d-Wise Technologies
Size: 1366 Kb Keywords:  clinical

 Applying Metadata Attributes in Analysis Data Sets Using Macro Variables and Proc SQL in SAS®
  Rita Tsang, Averion International Corporation
Size: 48 Kb Keywords:  SQL, macro

WUSS 2010

 Creating a Patient Profile using CDISC SDTM
  Marc Desgrousilliers
Size: 171 Kb 

 An Excel Framework to Convert Clinical Data to CDISC SDTM Leveraging SAS® Technology
  Ale Gicqueau
Size: 1233 Kb 

PhUSE 2010

 AstraZENeca and the ART of metadata maintenance
  Paul Frost, AstraZeneca
Size: 1000 Kb Keywords:  CDISC INHERITANCE MAPPING METADATA SAS
     Download the presentation (5668 Kb)

 Initial Investment in CDISC Data Standards in Clinical Organisations
  Kenneth Stolzfus, Octagon Research Solutions
Size: 60 Kb Keywords:  governance, standards, people, processes, technical solutions,, CDISC, clinical
     Download the presentation (1728 Kb)

 How Do I Map That? - SDTM Implementation Challenges
  Chris Price, Roche Products Ltd
Size: 208 Kb Keywords:  CDISC, SDTM, Legacy
     Download the presentation (814 Kb)

 From ACE to ZINC
  Paul Vervuren, MSD/NV Organon
Size: 439 Kb Keywords:  CDISC, SDTM, lab test, controlled terminology, LBTEST, LBTESTCD

New CDISC migration strategies and tools: determining the best approach and employing automated data mapping
  Michael Weitz, Cytel & Lauren Spiess, Cytel
Keywords:  CDISC
     Download the presentation (1237 Kb)

 How to go From an SDTM Findings Domain to an ADaM-Compliant Analysis Dataset: An Example
  Carl Heremans, Merck Sharp & Dohme (Europe)
Size: 51 Kb Keywords:  CDISC
     Download the presentation (856 Kb)

 Traceability between SDTM and ADaM converted analysis datasets
  Florence Somers, Business & Decision Life Sciences & Michael Knoessl, Boehringer Ingelheim Pharma GmbH & Co. KG
Size: 187 Kb Keywords:  CDISC, ADaM, Traceability, Quality Control
     Download the presentation (5335 Kb)

 Defining "Compliance" for Analysis Data
  Chris Decker, d-Wise Technologies & Randall Austin, GlaxoSmithKline
Size: 294 Kb 
     Download the presentation (1021 Kb)

 The Use of Meta Data in Creating, Transforming and Transporting Clinical Data
  Gregory Steffens, ICON
Size: 79 Kb Keywords:  clinical
     Download the presentation (246 Kb)

 Define.xml - Tips and Techniques for Creating CRT-DDS
  Julie Maddox, SAS Institute & Mark Lambrecht, SAS Institute (Size)
Size: 226 Kb Keywords:  CRT-DDS,DEFINE.XML, SAS Clinical Data Integration
     Download the presentation (6857 Kb)

 Accessing the metadata from the define.xml using XSLT transformations
  Lex Jansen, Octagon Research Solutions
Size: 984 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, XSLT
     Download the presentation (2151 Kb)

 Bridging the communication gap: implementing metadata standards in trial protocols
  Annabel Acs, Novo Nordisk
Size: 136 Kb 
     Download the presentation (641 Kb)

 CDISC integration in a clinical data management system
  Peter Van Reusel, Business & Decision Life Sciences
Size: 314 Kb Keywords:  CDISC, SDTM, Oracle Clinical, Remote Data Capture
     Download the presentation (6009 Kb)

 Implementing, Managing and Validating a Clinical Standard
  Gene Lightfoot, SAS Institute
Size: 574 Kb Keywords:  clinical
     Download the presentation (1785 Kb)

 Generate ATTRIB and FORMAT statements from the SAP
  Shafi Chowdhury, Shafi Consultancy Ltd
Size: 63 Kb Keywords:  ATTRIB, FORMATS, CDISC standard
     Download the presentation (203 Kb)

 Converting Data to CDISC Models: Research Project on Metadata Extraction, Exploration and Pooling
  Ronald Steinhau, Entimo AG & Dimitri Kutsenko, Entimo
Size: 89 Kb Keywords:  CDISC
     Download the presentation (3583 Kb)

Driving value through Standardization - Industry Challenges and Best Practices
  Henry Levy, Accenture

     Download the presentation (661 Kb)

 How can we do things better: A SAS Java Library Proposal and other stories
  Michael Auld, Michael Auld Consulting
Size: 350 Kb 

 BeST- BIOEQUIVALENCE STUDY TEMPLATE
  Pekka Heikkila, StatFinn
Size: 1500 Kb Keywords:  pharmacokinetics, PK, bioequivalence, ODS, RTF, CDISC, SDTM, ISO 8601, SAS
     Download the presentation (16178 Kb)

 Introduction to SAS® Clinical Standards Toolkit
  Andreas Mangold, HMS Analytical Software GmbH & Nicole Wachter, HMS Analytical Software GmbH
Size: 725 Kb Keywords:  clinical
     Download the presentation (1497 Kb)

SESUG 2010

 Tips and Tricks Of Efficient SAS® Programming for SDTM Data
  Eric Qi, Fikret Karahoda
Size: 45 Kb 

 A Taste of ADaM
  Beilei Xu, Changhong Shi
Size: 79 Kb 

PharmaSUG 2010

 Operational Uses of Patient Profiles ... Even in an eCTD and SDTM World
  Terek Peterson, Octagon Research Solutions; Sanjiv Ramalingam, Octagon Research Solutions
Size: 309 Kb Keywords:  Patient Profiles,eCTD,SDTM, CDISC

 How to validate SDTM SUPPQUAL data sets
  Kevin Lee, Covance
Size: 104 Kb Keywords:  validate , SDTM ,SUPPQUAL, CDISC

 ADaM Dataset Checking Toolkit
  Huei-Ling Chen, Merck & Co. Inc.
Size: 50 Kb Keywords:  ADaM . Checking, Toolkit

 Applying ADaM Principals in Developing a Response Analysis Dataset
  Mei Dey,Merck & Co.;Lisa Pyle, Merck & Co.
Size: 90 Kb Keywords:  CDISC, ADaM, Principals, Response Analysis

 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
Size: 393 Kb Keywords:  CDISC, FDA, SDTM, ADaM, Standards, Integration

 Help! The EX Domain is Now an Analysis Dataset! What Do I Do?!?
  David Izard, Octagon Research Solutions
Size: 99 Kb Keywords:  CDISC,EX Domain,Analysis Dataset

 How do we build ADaM from SDTM? A real case analysis
  Jianhua (Daniel) Huang, Forest Laboratories Inc
Size: 122 Kb Keywords:  ADaM ,SDTM, CDISC

 Automating the Process of Creating the Contents of Data Definition Document
  David Wang, Sanofi-aventis;Greg Ridge, Sanofi-aventis
Size: 254 Kb Keywords:  Define document, define.xml, define.pdf, SDTM, ADS, automate

 The SE Domain as Treatment Data Store: Using the SDTM Subject Elements (SE) domain to drive analyzing treatment
  Jeremy Gratt, Modular Informatics
Size: 537 Kb Keywords:  CDISC, SDTM, SE, Treatment

 Creating SV and SE first
  Henry Winsor, WinsorWorks,Limited;Mario Widel, Genentech
Size: 156 Kb Keywords:  SV,SE,data

 The 5 Biggest Challenges of ADaM
  Terek Peterson, Octagon Research Solutions;David Izard, Octagon Research Solutions
Size: 268 Kb Keywords:  ADaM,CDISC

 Quality in a World of Standards with Differences
  Sandra VanPeltNguyen, i3 Statprobe
Size: 48 Kb Keywords:  CDISC, SDTM, WebSDM, quality

 Achieving Efficiencies in CDISC SDTM Data Conversions and Its Challenges- Case Study
  Ilango Ramanujam, TAke Solutions Inc
Size: 224 Kb Keywords:  CDISC, SDTM conversion

 In-Depth Review of Validation Tools to Check Compliance of SDTM-Ready Clinical Datasets
  Bhavin Busa, Cubist Pharmaceuticals, Inc.;Kim Lindfield, Cubist Pharmaceuticals, Inc.
Size: 148 Kb Keywords:  OpenCDISC, SAS-CST, SDTM Validation Tools
     Download the presentation (1196 Kb)

 Accessing the metadata from the define.xml using XSLT transformations
  Lex Jansen, Octagon Research Solutions, Inc.
Size: 986 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the presentation (1322 Kb)

 Thanks CDISC “Free Utilities”
  Robert Agostinelli, Sepracor
Size: 171 Kb Keywords:  CDISC, OpenCDISC, SAS

 Checking for SDTM Compliance: The Need for Human Involvement
  Fred Wood, Octagon Research Solutions
Size: 83 Kb Keywords:  SDTM Compliance,CDISC

 Updating SDTM Metadata Excel File (Define.xls) with SAS
  Lin Yan, Merck & Co., Inc
Size: 75 Kb Keywords:  SDTM, Metadata, Define,Excel, CDISC

 SDTM Attribute Checking Tool
  Ellen Xiao, Merck
Size: 176 Kb Keywords:  SDTM ,Checking Tool, CDISC

 Editing SAS® Metadata Automated From CSV Files Using XML String in SAS® Data Integration Studio
  Annie Guo, ICON Clinical Research
Size: 157 Kb Keywords:  Proc MetadataProc Metalib,SDTM,DI Studio,SAS Open Metadata Interface, XML

 From SAP to ADaM: The Nuts and Bolts
  Nancy Brucken i3 Statprobe, ;Paul Slagle United Biosource Corp.
Size: 80 Kb Keywords:  SAP ,ADaM

 Accessing and using the metadata from the define.xml
  Lex Jansen, Octagon Research Solutions, Inc.
Size: 1004 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the presentation (1638 Kb)

 Insights into ADaM
  Matthew Becker, PharmaNet
Size: 483 Kb Keywords:  ADaM

 CDASH Standards for Medical Device Trials: CRF Analysis
  Parag Shiralkar, Eliassen Group;Jennie Tedrow, Boston Scientific;Kit Howard, Kestrel Consultants;Laura Fazio, DePuy Orthopaedics
Size: 132 Kb Keywords:  CDASH ,Standards, Medical Device Trials, CRF Analysis

 Medical Device and Diagnostic Industry 101
  Carey Smoak, Roche Molecular Systems, Inc.
Size: 32 Kb Keywords:  Device, Diagnostic, Approval, CDISC

 Exploring SAS® PROC CDISC Model ODM and Its Limitations
  Elena Valkanova, BioStat International, Inc.;Irene Droll, XClinical GmbH
Size: 134 Kb Keywords:  PROC CDISC Model ODM

 Case Study: Handling Non-English Clinical Trials Data in SDTM Conversions for US-FDA Submissions
  Ramanan Bathala, TAKE Solutions Limited
Size: 124 Kb Keywords:  Non-English Clinical Trials Data, SDTM Conversions, US-FDA Submissions, CDISC

 Using the SAS Clinical Standards Toolkit to Validate CDISC SDTM Data
  Gene Lightfoot, SAS Institute Inc.
Size: 1523 Kb Keywords:  CDISC

 Managing Clinical Data Standards: An Introduction to SAS® Clinical Data Integration
  Michael Kilhullen, SAS Institute Inc.
Size: 683 Kb Keywords:  Clinical Data Standards,Clinical Data Integration

SAS Global Forum 2010

 Using PROC CONTENTS Output to Perform Quality Control Checks on SDTM Data Sets
  Jennifer M. Srivastava
Size: 53 Kb 

 Understanding the define.xml File and Converting It to a Relational Database
  Lex Jansen
Size: 1101 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the workshop files (2021 Kb)

 Managing Clinical Data Standards: An Introduction to SAS® Clinical Data Integration
  Michael Kilhullen
Size: 715 Kb Keywords:  clinical ,

 Automating SDTM File Creation: Speeding Up the Process with Metadata Files
  Daphne Ewing
Size: 91 Kb 

 Dealing with Lab Data: Stacking the Deck in Your Favor
  Jennifer K. Fulton
Size: 211 Kb 

 The Past, Present, and Future of Clinical Data Standards
  Chris Decker
Size: 600 Kb Keywords:  clinical ,

 SDTM Attribute-Checking Tool
  Ellen Xiao
Size: 172 Kb 

SESUG 2009

 A SAS® Macro to Automate the Process of Define.xml
  Wenyu Hu, Liping Zhang
Size: 61 Kb Keywords:  xml, macro

 Exploring SAS® PROC CDISC Model=ODM and its Undocumented Parameters
  Elena Valkanova, Irene Droll
Size: 99 Kb 

 Mapping Nested e-CRF Data into SDTM Domains
  Venkata Sekhar Bhamidipati and Kristi L. Garner
Size: 170 Kb 

PhUSE 2009

 SDTM Validation: How can we do it right?
  Peter Van Reusel, Business & Decision Life Sciences
Size: 854 Kb Keywords:  CDISC, SDTM Validation
     Download the presentation (1326 Kb)

 Generate Define.xml & Define.pdf from Metadata Environment
  Rohit Banga, Business & Decision Life Sciences
Size: 246 Kb Keywords:  Define Define.xml Define.pdf CDISC SDTM ODM Metadata
     Download the presentation (1346 Kb)

 An Evaluation of the ADaM Implementation Guide v1.0 and the Analysis Data Mode v2.1
  Chris Price, Roche
Size: 33 Kb 
     Download the presentation (159 Kb)

 Insights into ADaM
  Matthew Becker, PharmaNet
Size: 526 Kb Keywords:  ADaM analysis metadata ADSL
     Download the presentation (832 Kb)

 Using SAS Clinical Data Integration Server to Implement and Manage CDISC Standards
  Julie Maddox, SAS Institute
Size: 433 Kb Keywords:  CDISC, clinical
     Download the presentation (822 Kb)

 The SAS Clinical Standards Toolkit
  David Smith, SAS Institute
Size: 2464 Kb Keywords:  clinical
     Download the presentation (1541 Kb)

 The CDISC/FDA Integrated Data Pilot: A Case Study in Implementing CDISC Standards to support an Integrated Review
  Chris Decker, d-Wise Technologies
Size: 218 Kb Keywords:  CDISC, FDA, SDTM, ADaM, Standards, Integration
     Download the presentation (476 Kb)

 From raw data to submission: A metadata-driven, repository-based process of data conversion to CDISC
  Dimitri Kutsenko, Entimo
Size: 427 Kb Keywords:  CDISC, SDTM, define.xml, conversion, mapping, legacy, metadata, repository
     Download the presentation (161 Kb)

Standardization of data base: interaction between Biostatistics and Clinical Data Management
  Céline Tendero, Sanof-Aventis
Keywords:  clinical
     Download the presentation (73 Kb)

 Converting the define.xml to a Relational Database to Enable Printing and Validation
  Lex Jansen, Octagon Research Solutions
Size: 888 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the presentation (2158 Kb)

 Using SAS Macros to simplify preparation and validation of SDTM data, Annotated CRFs and Define.xml in a metadata driven environment
  Niels Both, S-cubed
Size: 516 Kb Keywords:  RELREC SUPPQUAL SDTM, CDISC, macro, xml
     Download the presentation (313 Kb)

Kendle Implementation of CDASH
  Elke Sennewald, Kendle & Gill Lawrence, Kendle

     Download the presentation (635 Kb)

 Implementation of ADaM standards NOT driven by a submission
  Karin Fleischer, Ferring Pharmaceuticals
Size: 222 Kb 
     Download the presentation (199 Kb)

 Experiences and lessons learned from a first SDTM submission project
  Paul Vervuren, Schering-Plough & Bas van Bakel, OCS Consulting
Size: 491 Kb Keywords:  CDISC SDTM submission late-stage conversion define.xml WebSDM
     Download the presentation (619 Kb)

 After a new CDISC SDTM version, how to update and manage ADS/SDS DEFINE files at company team level
  Nathalie Moro, Sanofi-Aventis
Size: 201 Kb Keywords:  CDISC

NESUG 2009

 Sol LeWitt and the CDISC Initiative: A Comparative Essay
  Karin LaPann, ViroPharma Inc.
Size: 186 Kb 

 A Proposed SDTM Implementation of Response Data for Solid Tumor Trials in Oncology
  Mei Dey, Merck & Co., Inc. Elisabeth Pyle, Merck & Co., Inc.
Size: 423 Kb 

 Successful Lab Result Conversion for LAB Analysis Data with Minimum Effort
  Pushpa Saranadasa, MERCK Inc.
Size: 98 Kb 

 A Taste of SDTM in Real Time
  Changhong Shi, Merck & Co. Beilei Xu, Merck & Co., Inc.
Size: 90 Kb 

 A Complete Derivation of Duration and Display in ISO 8601 Using SAS Program
  Joyce Gui, JPG Advanced Techology Helen Wang, Merck & Co., Inc. Sandy Wang, Rutgers, The State University of New Jersey
Size: 91 Kb 

 Supporting CDISC Standards in Base SAS® Using the SAS® Clinical Standards Toolkit
  Peter Villiers, SAS Institute
Size: 608 Kb Keywords:  clinical

WUSS 2009

 BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users
  Clinton Brownley (independent statistical consultant)
Size: 180 Kb 

 The Second CDISC Pilot Project: A Metastandard for Integrating Databases
  Gregory Steffens (Eli Lilly & Co.), Ian Fleming (Genentech, Inc.)
Size: 70 Kb 

 CDISC Implementation on a Rheumatoid Arthritis Project Partnership
  Patricia Gerend (Genentech, Inc.), Chris Price, Oliver LeConte (Roche Products Limited), Michelle Zhang (Genentech, Inc.)
Size: 87 Kb 

 How a SAS/IntrNet tool was created at the FDA for the detection of potential drug-induced liver injury using data with CDISC standard
  Ted Guo, John Senior, Kate Gelperin (FDA)
Size: 481 Kb 

 CDISC for the Medical Device and Diagnostic Industry: An Update
  Carey Smoak (Roche Molecular Systems, Inc.)
Size: 54 Kb Keywords:  CDISC, SDTM, CDASH, Devices, Diagnostics

 The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
  Fred Wood (Octagon Research Solutions, Inc.)
Size: 146 Kb Keywords:  SAS Drug Development, Report Management, User Interface, Application Development, Regulatory Compliance, Web-enabled

PharmaSUG 2009

 Converting CDISC Controlled Terminology to SAS Formats
  Sandeep Juneja
Size: 198 Kb Keywords:  CDISC

 Clinical Data Acquisition Standards Harmonization (CDASH) Standard Version 1.0
  Kim Truett
Size: 30 Kb Keywords:  CDISC, CDASH

 Using CDISC Lab Terminology and Determining Standard Units
  Mat Davis
Size: 92 Kb Keywords:  CDISC

 Understanding the define.xml and converting it to a relational database
  Lex Jansen
Size: 1578 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the code (68 Kb)

 The Second CDISC Pilot - A Metastandard for Integrating Databases
  Gregory Steffens
Size: 42 Kb Keywords:  CDISC

 A Practical Introduction to Clinical Data Acquisition Standards Harmonization (CDASH)
  Jennifer Price
Size: 70 Kb Keywords:  CDASH SDTM CDISC CRF

 Nice SUPPQUAL Variables to Have
  Beilei Xu
Size: 68 Kb 

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

 Creating the Case Report Tabulation (CRT) for an NDA submission at the absolute last moment - NOT
  Steve Wong
Size: 217 Kb Keywords:  define.pdf; CDISC; CRT; Case Report Tabulation; eCTD; Submission; MetaData; NDA; New Drug Application; Documentaion; BLA; Biologics License Application

 Implementing CDISC When You Already Have Standards
  Sandra Minjoe
Size: 187 Kb Keywords:  CDISC, standard, adopt, implement, convert, strategy, decision, resource, FDA

 Converting the define.xml to a relational database to enable printing and validation
  Lex Jansen
Size: 1615 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the presentation (2645 Kb)

 Data Conversion to SDTM - What Sponsors Can Do to Facilitate the Process
  Fred Wood
Size: 146 Kb Keywords:  CDISC

Using SAS® Clinical Data Integration Server to Implement and Manage CDISC Standards
  Michael Kilhullen
Keywords:  CDISC

 Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit
  Peter Villiers
Size: 595 Kb Keywords:  CDISC

SAS Global Forum 2009

 HL7, CDISC, and the FDA—Moving on Down the Path to Data Standards
  Steve Wilson
Size: 17 Kb 

 Supporting CDISC Standards in Base SAS® Using the SAS® Clinical Standards Toolkit
  Peter Villiers
Size: 588 Kb Keywords:  clinical ,

 Implementing CDISC When You Already Have Standards: A Case Study
  Sandra Minjoe
Size: 221 Kb 

 A SAS® Programmer’s Guide to Generating Define.xml
  Michael Molter
Size: 172 Kb Keywords:  xml ,

 Using SAS® Clinical Data Integration Server to Implement and Manage CDISC Standards
  Michael Kilhullen
Size: 899 Kb Keywords:  clinical ,

 The Second CDISC Pilot Project: Standards for Integrating Databases
  Ian Fleming, Gregory Steffens
Size: 48 Kb 

 Backpacking Your Way through CDISC: A Budget-Minded Guide to Basic Concepts and Implementation
  Rachel Brown, Jennifer K. Fulton
Size: 118 Kb 

 Mapping CDISC Metadata Attributes: Using DATA _NULL_ and PROC DATASETS in SAS®
  Rita Tsang
Size: 460 Kb 

SESUG 2008

 A Programming Methodology for Creating CDISC Domain Data Sets
  John R. Gerlach
Size: 819 Kb 

 An Approach for Deriving a Timing Variable in SDTM Standards
  Shaoan Yu, Joyce Gui
Size: 874 Kb 

PhUSE 2008

 The application of SDTM in a disease (oncology)-oriented organization
  Angelo Tinazzi, Alessandro Cattaneo, Enrica Paschetto, Sonia Colombini SENDO-Tech S.r.l
Size: 510 Kb Keywords:  CDISC

 CDISC Implementation Strategies: Exploit your data assets while still giving the FDA what they want
  David Smith, SAS Institute
Size: 517 Kb Keywords:  CDISC

 Implementing CDISC at Boehringer Ingelheim
  Michael Knoessl, Boehringer Ingelheim, Peter Leister, IBM
Size: 61 Kb Keywords:  CDISC, SDTM, Clinical Data Model, Boehringer Ingelheim

 Using the SAS® XML Mapper and ODS to create a PDF representation of the define.xml
  Lex Jansen, Octagon Research Solutions
Size: 1253 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the presentation (2779 Kb)

In at the Deep-End (thoughts on mapping multiple studies into CDISC for an ISS/ISE)
  Andrew Noller. Qunitiles
Keywords:  CDISC

CDISC - an overview, How far have we come, where are we going and what is the next step
  Ann-Sofie Bergstrom, SAS Institute
Keywords:  CDISC

CDISC SDTM, ADaM and Metadata : Connecting the Standards
  Joel Hoffman, Waban Software
Keywords:  CDISC

 CDISC: Implementation Strategies for SDTM
  Brian Mave, UCB Pharma
Size: 133 Kb Keywords:  SAS autocall alias macro library versioning, CDISC

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

NESUG 2008

 An Approach to CDISC SDTM Implementation for Clinical Trials Data
  William Chen, Merck & Co., Inc.; Margaret M. Coughlin, Merck & Co., Inc.
Size: 59 Kb Keywords:  clinical

 Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed)
  Lex Jansen, Octagon Research Solutions, Inc.
Size: 1260 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF
     Download the presentation (2429 Kb)

 An Animated Guide: the Logical cascade when entering Orres data
  Russ M. Lavery, Self
Size: 203 Kb 

PharmaSUG 2008

 Cost-Effective Solution to Automating the Creation of CDISC define.xml: Using SAS Data _Null_ with Relational Data Model via SAS/AF Application
  Annie Guo, ICON Clinical Research
Size: 534 Kb Keywords:  CDISC, xml, af

 A Toolkit for CDISC Implementation
  Robert Stemplinger, ICON Clinical Research
Size: 30 Kb Keywords:  CDISC

 SDTM, Plus or Minus
  Barry Cohen, Octagon Research Solutions, Inc.
Size: 129 Kb Keywords:  CDISC

 A SAS based solution for define.xml
  Monika Kawohl, Accovion
Size: 362 Kb Keywords:  define.xml, CDISC, electronic submissions

 Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry
  Carey Smoak, Roche Molecular Systems, Inc.
Size: 53 Kb Keywords:  CDISC, Device, Diagnostic

 Experiences Submitting CDISC SDTM and JANUS Compliant Datasets
  Carol R Vaughn and Greg Ridge (Sanofi-Aventis)
Size: 61 Kb Keywords:  Janus, WebSDM, rule violations, SDTM, CDISC

 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
Size: 1266 Kb Keywords:  define.xml, CDISC, SDTM, SAS, XML Mapper, PDF

 Case Study: Analysis and Metrics of End-to-End Legacy Data Conversions into SDTM, ADaM, and Define.xml
  Robert Stemplinger, ICON Clinical Research
Size: 49 Kb Keywords:  CDISC, xml

 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.)
Size: 358 Kb Keywords:  CDISC, macro

 Managing The Change And Growth Of A Metadata-Based System
  Frank DiIorio, CodeCrafters, Inc.
Size: 472 Kb Keywords:  metadata; CDISC; FDA submissions; project management; metadata tools; user interface

 The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
  Fred Wood, Octagon Research Solutions
Size: 213 Kb Keywords:  CDISC

 A regulatory submission “DEFINE”d: The who, where, and what.
  Robert Diseker, PPDI
Size: 436 Kb 

 SAS, CDISC and Clinical Data Integration
  Peter Villiers, SAS Institute Inc.
Size: 4697 Kb Keywords:  CDISC

SAS Global Forum 2008

 Using Excel XP to Display SDTM Metadata and More
  Christine Teng, Shaoan Yu
Size: 182 Kb Keywords:  ExcelXP, Tagset, SAS Dictionary, PROC SQL

 The Evolution of SAS® in Life Sciences Research and Development
  David Handelsman
Size: 422 Kb Keywords:  pharmaceutical biotechnology CDISC

 CDISC: Pains and Pitfalls of Data Set Creation
  Steven L. Michaelson, Janet Stuelpner
Size: 35 Kb Keywords:  CDISC SDTM

 Practical Methods for Creating CDISC SDTM Data Sets from Existing Data
  Robert W. Graebner
Size: 892 Kb 

NESUG 2007

 Benefits of Using Excel File in CDISC SDTM Data Mapping
  Hong Wang, Clinforce LLC
Size: 615 Kb 

 Relationships Between ORRES and Other CDISC Variables (CDISC Variable Relationships Part 1 of 3)
  Susan Fehrer, BioClin; Russ Lavery, Independent Consultant
Size: 570 Kb Keywords:  CDISC relationship ORRES STRESC STRESN STRESU

 Relationships Between CDISC Variables Concerning Day and Date (CDISC Variable Relationships Part 2 of 3)
  Susan Fehrer, BioClin; Russ Lavery, Independent Consultant
Size: 388 Kb 

 Relationships Between CDISC Variables Linking Domains (relrec) (CDISC Variable Relationships Part 3 of 3)
  Susan Fehrer, BioClin; Russ Lavery, Independent Consultant
Size: 358 Kb Keywords:  RELREC CDISC Variable Relationships

PhUSE 2007

 MAKS: A validated SAS Macro Library for Clinical Data in the CDISC SDTM Structure
  Rolf Meinert, Katrin Bhalla-Muller, Jessica Wisniewski, Daniel Wachtlin; KKS-Mainz, Mainz, Germany (www.kks-mainz.de); Platform for Medical Research Networks (www.tmf-ev.de)
Size: 28 Kb Keywords:  CDISC, macro, clinical

 Standardizing FDA Data to Improve Success in Pediatric Drug Development
  Julie Maddox, SAS Institute, Cary, NC, USA; Chris Decker, SAS Institute, Cary, NC, USA
Size: 209 Kb Keywords:  CDISC,SDTM, FDA

 A SAS based solution for define.xml
  Monika Kawohl, Accovion GmbH, Marburg, Germany
Size: 481 Kb Keywords:  define.xml, CDISC, electronic submissions

 Relationships Among CDISC Variables Concerning Day and Date (CDISC Variable Relationships Part 2 of 3)
  Susan Fehrer (BioClin, Inc.) and Russ Lavery
Size: 216 Kb Keywords:  CDISC

 Relationships Between CDISC Variables Linking Domains (RELREC) (Part 3 of 3)
  Susan Fehrer (BioClin, Inc.) and Russ Lavery
Size: 213 Kb Keywords:  CDISC

 Creation of Submission and Analysis Data Sets by following the SDTM and ADAM requirements
  Yvane Boudraa, sanofi-aventis pharma, Antony, France
Size: 118 Kb Keywords:  CDISC

 MDMAP (Meta Data Management and Publishing) An application utilized in the management of clinical trial metadata
  Herve Guimard, Sanofi-Aventis, France; Eric Sorel, Sanofi-Aventis, France
Size: 257 Kb Keywords:  clinical

 A validated tool to create the Submission and Analysis Data Sets
  Claude Guyot, sanofi-aventis pharma, Chilly-Mazarin, France
Size: 152 Kb 

 All roads lead to SDTM - which one shall we take?
  Ian Fisher, AstraZeneca, Alderley Park, UK; Meena Rahman, AstraZeneca, Alderley Park, UK; Donna Thompson, AstraZeneca, Alderley Park, UK
Size: 58 Kb Keywords:  CDISC

 Considerations for CDISC implementation
  Robert T. Stemplinger, ICON Clinical Research, Redwood City, CA; Jackie Lane, ICON Clinical Research, Redwood City, CA
Size: 36 Kb Keywords:  CDISC

 Relationships Among - -ORRES and Other CDISC Variables (Part 1 of 3)
  Susan Fehrer (BioClin, Inc.) and Russ Lavery
Size: 276 Kb Keywords:  CDISC

PharmaSUG 2007

 A Conceptual Framework For Clinical Trials - Interoperability And Automation In A Web-based Environment
  John Gerlach, MaxisIT, Inc.; Maulik Shah, MaxisIT, Inc.
Size: 82 Kb Keywords:  Interoperability, CRT-DDS, XML, CDISC, SDTM, internet

 The Submission Data File System - Automating the Creation of CDISC SDTM and ADaM Datasets
  Marcus G Bloom, Amgen; David Edwards, Amgen
Size: 3041 Kb Keywords:  SDF, CDISC, SDTM, ADaM, Software Development, SAS, Java, Oracle'; 'SDF, CDISC, SDTM, ADaM, Software Development, SAS, Java, Oracle

 Customizing DI Studio to Generate CDISC Compliant SDTM Domains
  Tatyana Kovtun, Berlex Laboratories; John Markle, Berlex Labs; Chris Treglio, Berlex Laboratories
Size: 374 Kb Keywords:  DI Studio, Java plug-in, generic job module, CDISC

 Taking a Walk on the Wildside: Use of the PROC CDISC-SDTM 3.1 Format
  William C Csont, H.M. Proskin & Associates, Inc.
Size: 48 Kb Keywords:  PROC CDISC SDTM

 CDISC: Pains and Pitfalls to Dataset Creation
  Janet Stuelpner, Left Hand Computing; Steven Michaelson, Simulstat, Inc.
Size: 56 Kb Keywords:  CDISC, macros

 Considerations for CDISC Implementation
  Robert T Stemplinger, ICON Clinical Research; Jackie Lane, ICON Clinical Research
Size: 50 Kb Keywords:  CDISC ODM SDTM ADAM PROC CDISC XML

 SDTM, Plus or Minus
  Barry R Cohen, Octagon Research Solutions, Inc.
Size: 143 Kb Keywords:  SDTM, CDISC, SDTM-plus, SDTM-minus, Data Standards

 A Harmonized, Report-Friendly SDTM and ADaM Data Flow
  Aileen L Yam, sanofi-aventis
Size: 78 Kb Keywords:  CDISC, SDTM SDS, ADaM, data flow, standards, report-friendly, domain

 From CRF Data to DEFINE.XML: Going “End to End” with Metadata
  Frank C DiIorio, CodeCrafters, Inc.; Jeffrey M Abolafia, Rho, Inc.
Size: 719 Kb Keywords:  Metadata, NDA submissions, clinical trials, DEFINE.XML, CDISC, SDTM

 Strategies and Practical Considerations for Creating CDISC SDTM Domain Data Sets from Existing CDM Data Sets
  Robert W Graebner, GRAE Tech
Size: 486 Kb Keywords:  CDISC,SDTM,Metadata Mapping,Proc CDISC

 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
Size: 527 Kb Keywords:  FDA, CDISC, eCTD, ADaM, SDTM, CRO, Vendor Management

 Evolution and Implementation of CDISC Study Data Tabulation Model (SDTM)
  Frederick Wood, Octagon Research Solutions, Inc.; Thomas Guinter, TAKE Solutions, Inc.
Size: 172 Kb Keywords:  CDISC, SDTM, data standards, case report tabulation
     Download the presentation (421 Kb)

 CDISC for the Medical Device and Diagnostic Industry
  Carey G Smoak, Roche Molecular Systems
Size: 98 Kb Keywords:  CDISC, Device, Diagnostic

 CDISC Implementation Step by Step: A Real World Example
  Sy J Truong, Meta-Xceed, Inc.; Patricia Gerend, Genentech, Inc.
Size: 738 Kb Keywords:  CDISC, SDTM 3.1, Data Standards, Data Transformation

 Relationships Among Variables in CDISC Domains
  Susan M Fehrer, BioClin, Inc.
Size: 317 Kb Keywords:  CDISC, SDTM, DOMAIN, relationships

 Best Practices for Working with CDISC Metadata in the SAS® Data Integration Server
  Michael Kilhullen, SAS Institute, Cary, NC
Size: 174 Kb Keywords:  CDISC, Metadata, Data Integration Server, XML, Metadata Server

 Implementing CDISC Data Models in the SAS® Metadata Server
  Michael Kilhullen, SAS Institute, Cary, NC
Size: 391 Kb Keywords:  CDISC, Metadata Server, Data Integration Studio, SDTM

 The use of CDISC Standards in SAS from Data Capture to Reporting
  Andrew Fagan, SAS Institute, Cary, NC; John Leveille, d-Wise Consulting, Raleigh, NC
Size: 1888 Kb Keywords:  CDISC, SDTM, SAS DI, SAS Drug Development

 Developing Reporting and Analysis Methodologies
  Amy E Gillespie, Merck & Co., Inc.; Mary Varughese, Merck & Co., Inc
Size: 48 Kb Keywords:  CDISC, SDTM, ADaM, SAS Drug Development, analysis, reporting

SAS Global Forum 2007

 Extending SAS® Data Integration Studio with Java: Custom GUIs and SAS Server Interactions
  Christopher Treglio
Size: 482 Kb Keywords:  define.xml 'Workspace Server' 'Metadata Server' CDISC SDTM 'ETL Studio'

 Keynote Presentation: Standards for Clinical Research from Protocol Through Submission: CDISC Business Case and Progress Report
  Rebecca Kush
Size: 17 Kb Keywords:  CDISC, clinical

 SAS Response: Concepts and Thoughts for a CDISC /FDA Pilot and Interfacing with HL7 RCRIM Projects
  Edward D. Helton
Size: 17 Kb 

 Customer Case Study: The Use of Metadata in the CDISC SDTM/ADaM Pilot Project
  Gregory C. Steffens
Size: 17 Kb Keywords:  FDA CDISC SDTM ADaM metadata

 Customer Case Study: Overview of the CDISC Pilot Project
  Greg Anglin
Size: 16 Kb 

 Customer Case Study: Building a Clinical Trials Data Repository using the CDISC SDTM standards and ETL
  Musa Nsereko
Size: 16 Kb Keywords:  clinical ,

 What's New in the XML LIBNAME Engine
  Tony Friebel, Richard Foley
Size: 16 Kb Keywords:  CDISC, XBRL, WSDL, SOAP, EXPORT, Oracle9i, XQuery, xml

PhUSE 2006

 Contours of a Drug Development Data Warehouse
  Paul Vervuren, NV Organon; Frank Dietvorst, PW Consulting
Size: 870 Kb Keywords:  data warehouse, drug development, clincial data, data model, CDISC, warehouse architecture

 Submission Data File System (SDF)
  David Edwards, Amgen; Marcus Bloom, Amgen
Size: 662 Kb Keywords:  SDF, CDISC, SDTM, ADaM, Software Development, SAS, Java, Oracle

 Converting Data to the SDTM Standard Using SAS Data Integration Studio
  Barry Cohen, Octagon Research Solutions, Inc.
Size: 332 Kb Keywords:  CDISC Standards, SDTM, Data Integration Studio, data conversion, data integration

 Using CDISC Models for the Analysis of Safety Data
  Susan Kenny, Inspire Pharmaceuticals, Inc.; Ed Helton, SAS Institute
Size: 321 Kb Keywords:  CDISC, SDTM, ADaM, safety analysis, analysis datasets

 The use of CDISC Standards in SAS from Data Capture to Reporting
  Andrew Fagan, SAS; John Leveille, d-wise
Size: 2056 Kb Keywords:  CDISC

SESUG 2006

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

WUSS 2006

 New CDISC Training Initiative
  Dana Rafiee, Destiny Corporation, Rocky Hill, CT
Size: 25 Kb 

 Step by Step PROC CDISC and More
  Sy Truong, Meta-Xceed, Inc, Milpitas, CA
Size: 921 Kb Keywords:  PROC CDISC, SDTM, ODM, CDISC Implementation

NESUG 2006

 Using SAS Data Integration Studio to Convert Clinical Trials Data to the CDISC SDTM Standard
  Barry Cohen, Octagon Research Solutions, Inc
Size: 255 Kb Keywords:  data integration, Data Integration Studio, CDISC, SDTM, data standards, clinical

 ISO 8601 - An International Standard for Date and Time Formats
  Shi-Tao Yeh, GlaxoSmithKline
Size: 80 Kb 

 Using PROC CDISC
  Chauthi Nguyen, GlaxoSmithkline
Size: 147 Kb 

PharmaSUG 2006

 Mapping Clinical Data to a Standard Structure: A Table Driven Approach
  Nancy Brucken, i3 Statprobe; Paul Slagle, i3 Statprobe
Size: 41 Kb Keywords:  standards, mapping, CDISC, integrated, table-driven

 MDMAP - An Innovative Application Used To Manage Clinical Trial Metadata
  Gregory S. Ridge, Sanofi-Aventis; Neeru Bhardwaj, Sanofi-Aventis
Size: 262 Kb Keywords:  eSUB, metadata, FDA, clinical trials, oracle, SAS

 Managing Clinical Trials Data using SAS® Software
  Martin J. Rosenberg, MAJARO InfoSystems, Inc.
Size: 316 Kb Keywords:  ClinAccess, SAS/SHARE, database, imaging, CDISC, clinical data management

 Cost Effective Ways to Generate Define.PDF & Define.XML
  Sy J. Truong, MXI, Meta-Xceed, Inc.
Size: 331 Kb Keywords:  Data Definition Documentation, DEFINE.PDF, DEFINE.XML

 Evolution and Implementation of CDISC Study Data Tabulation Model (SDTM)
  Tom S. Guinter, Octagon Research Solutions, Inc.; Fred Wood, Procter & Gamble Pharmaceuticals
Size: 157 Kb Keywords:  SDTM, CDISC, NDA, Standards, CRT

 Using SAS ETL Studio to Convert Clinical Trials Data to the CDISC SDTM
  Barry R. Cohen, Octagon Research Solutions, Inc.
Size: 89 Kb Keywords:  ETL Studio, CDISC, SDTM, Data Conversion, Data Mapping

 CDISC Implementation, Real World Applications
  Sy J. Truong, MXI, Meta-Xceed, Inc.
Size: 976 Kb Keywords:  CDISC, SDTM 3.1, Data Standards, Data Transformation

 CDISC Submission and Compliance Training, The New Virtual Learning Methodology
  Dana Rafiee, Destiny Corporation; Michael Palmer, Zurich Biostatistics
Size: 133 Kb Keywords:  CDISC, submission, compliance training

 Implementing CDISC Data Models in the SAS® Metadata Server
  Michael Kilhullen, SAS Institute
Size: 416 Kb Keywords:  CDISC, data models, metadata

 UPDATE:CDISC Interchange Abstract Harmonizing CDISC Submission Models - SDTM and ADaM
  Edward Helton, Ph.D., SAS Institute; Stephen Ruberg, Ph.D., Eli Lilly; Cathy Barrows, GlaxoSmithKline; Musa Nsereko, Cephalon; Greg Anglin, Eli Lilly
Size: 94 Kb Keywords:  CDISC, SDTM, ADaM

PhUSE 2005

 An Introduction to CDISC - What is CDISC and Why Standards?
  Laurie Rose, SAS Institute & Becky Kush, CDISC
Size: 1223 Kb Keywords:  CDISC

 An Introduction to CDISC - Available CDISC Standards and Models and How SAS Supports These
  Laurie Rose, SAS Institute
Size: 1612 Kb Keywords:  CDISC

 An Introduction to CDISC - CDISC Collaborations and Standards in Progress
  Becky Kush, CDISC
Size: 1531 Kb Keywords:  CDISC

 Pharmacovigilance Using SAS Technology , Analytics and CDISC Data Standards, including the SDTM-ADaM Submission Relationship
  Ed Helton, SAS Institute
Size: 1498 Kb Keywords:  CDISC

 ODM & define.xml
  Dave Iberson-Hurst, Assero Limited
Size: 924 Kb Keywords:  xml

 SAS Dataset Content Conversion to CDISC Data Standards
  Tony Friebel, SAS Institute
Size: 270 Kb Keywords:  CDISC

 Software Tools for working with CDISC ODM, SDTM, LAB and define.xml
  Jozef Aerts, XML4Pharma
Size: 33 Kb Keywords:  CDISC, xml
     Download the presentation (127 Kb)

 Customer oriented CDISC implementation
  Edelbert Arnold, Accovion GmbH & Ulrike Plank, Accovion GmbH
Size: 233 Kb Keywords:  CDISC SDTM ADaM define.xml Implementation
     Download the presentation (176 Kb)

 Mapping Corporate Data Standards to the CDISC Model
  David Parker, Astra Zeneca
Size: 296 Kb Keywords:  CDISC
     Download the presentation (956 Kb)

 The Future of CDISC
  Becky Kush, CDISC
Size: 1046 Kb Keywords:  CDISC
     Download the presentation (3421 Kb)

 CDISC Activities in Europe
  Udo Siegmann, Parexel International
Size: 310 Kb Keywords:  CDISC

 Managing Clinical Trials Data using SAS
  Martin Rosenberg, MAJARO InfoSystems
Size: 1530 Kb Keywords:  ClinAccess, SAS/SHARE, database, imaging, CDISC, clinical data management

 Customer oriented CDISC implementation
  Edelbert Arnold, Accovion & Ulrike Plank, Accovion
Size: 453 Kb Keywords:  CDISC

WUSS 2005

 A Macro Mapping Date and Time Variable to CDISC Date and Time Variable
  Song Liu, Brett Sellars, Biogen Idec, San Diego, California
Size: 233 Kb 

 Data Integrity through DEFINE.PDF and DEFINE.XML
  Sy Truong, Meta-Xceed, Inc, Fremont, CA
Size: 582 Kb 

 Transforming Data for CDISC and ISS
  Sy Truong, Meta-Xceed, Inc, Fremont, CA
Size: 577 Kb 

NESUG 2005

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

PharmaSUG 2005

 CDISC for electronic submissions - A Table Translation Program
  John H. Adams, Boehringer Ingelheim; Kirill Tchernakov, Boehringer Ingelheim
Size: 319 Kb Keywords:  MACRO, CDISC, DYNAMIC PROGRAMMING, METADATA, EXCEL

 Implementation of the CDISC SDTM at the Duke Clinical Research Institute
  Jack Shostak, Duke Clinical Research Institute
Size: 243 Kb Keywords:  SDTM CDISC

 Strategies for Implementing SDTM and ADaM Standards
  Susan J. Kenny, Maximum Likelihood Solutions
Size: 239 Kb Keywords:  CDISC, SDTM, ADaM, FDA, analysis datasets, submission files

 Program Flow Design for Efficient CRT Programming
  Sam Mao, Quintiles, Inc.; Sid G. Morris, Quintiles, Inc.
Size: 100 Kb Keywords:  CRT, CDISC, SDM, SDTM, SDS, Programming Flow Design

 Pharmacovigilance and Drug Safety Reporting Algorithms (Content and Process)
  David Olaleye, SAS Institute
Size: 145 Kb Keywords:  CDISC, FDA

 SAS® Dataset Content Conversion to CDISC Data Standards
  Anthony Friebel, SAS Institute; Thomas Cox, SAS Institute; Edward Helton, SAS Institute
Size: 486 Kb Keywords:  CDISC, ODM, metadata

SUGI 30

 Data Standards and CDISC: A Statistical Perspective
  Steve Wilson
Size: 26 Kb 

 Investigational Data in XML according to the CDISC Operational Data Model
  Edward D. Helton
Size: 29 Kb Keywords:  xml ,

WUSS 2004

 The Path to Data Standards
  Sy Truong, Meta-Xceed, Inc, Fremont, CA 
Size: 519 Kb Keywords:  Data Standard, CDISC, SDM, meta data

 Successful FDA Advisory Meetings by using Analysis Datasets
  Sandy Chang, Steve Wong; Gilead Sciences, Inc., Foster City, California
Size: 641 Kb Keywords:  Analysis Datasets, Advisory Committee Meeting, FDA, NDA, CDISC ADaM

PharmaSUG 2004

 Data Standards With and Without CDISC
  Sy J. Truong, Meta-Xceed, Inc.
Size: 599 Kb Keywords:  Data Standard, CDISC, SDM, meta data

 An FDA-Requested XML Replacement for SAS Version 5 Transport Files in U.S. Regulatory Submissions
  Michael C. Palmer, Zurich Biostatistics, Inc.
Size: 127 Kb Keywords:  FDA, version 5 transport files, ODM, XML, CDISC, submissions, CRT

 Defining and Validating CDISC Data Standards to XML in SAS Technology
  Anthony Friebel, SAS Institute; Edward Helton, SAS Institute; Eugenia Bastos, SAS Institute; Michael Kilhullen, SAS Institute; Jane Boone, CDISC
Size: 270 Kb Keywords:  CDISCOperational Data ModelSubmissions DatasetsODM SDSXMLSchemaMetadataData managementeCTDHL7Data standardsClinical trialsClinical studiesDrug studiesXMLMapXML MapperODM ViewerXML LibnameBase SASFDAGuidanceSDTM

SUGI 29

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

PharmaSUG 2003

 CDISC, ADaM, and TTE: What Are These Acronyms and How Can They Help Me With My Filing?
  Sandra Minjoe, Genentech, Inc.; Judy Phelps, Pfizer
Size: 132 Kb Keywords:  ADaM analysis CDISC dataset FDA filing model submission time-to-event

 Clinical Data Model and FDA/CDISC Submissions
  Mark Edwards, Boston Scientific; Gajanan Bhat, Boston Scientific
Size: 321 Kb Keywords:  FDA CDISC SDM ODM XML

 CDISC: Why SAS® Programmers Need to Know
  Victor Sun, Novartis Pharmaceuticals Corp.
Size: 33 Kb Keywords:  CDISC Patient profile Electronic submission XML Metadata CRT datasets

 Testing CDISC's Operational Data Model in SAS
  Michael Palmer, Zurich Biostatistics, Inc; Julie Evans, CDISC
Size: 94 Kb Keywords:  CDISC ODM XML FDA Tekoa ZBI NDA BLA Zurich Biostatistics

 Clinical Data Standards - An eSubmissions Perspective
  Shylendra Kumar, Datafarm, Inc; Gajanan Bhat, Boston Scientific Corporation
Size: 453 Kb Keywords:  esubmission crt item 11 enda ebla cdisc fda

SUGI 28

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

PharmaSUG 2002

 The CDISC Laboratory Data Interchange Standard: Using SAS® To Read and Write CDISC Compliant Data Sets and Files
  Margaret Hung, GlaxoSmithKlin; Philip Pochon, Covance Central Laboratory Services, Inc.
Size: 143 Kb Keywords:  CDISC, lab, lab data, XML, ASCII, SDM, ODM, metadata, Covance, GSK

 Implementing a Standardized Data Model - A Real Life Experience
  Curtis Wolf, DataCeutics; Paul Gilbert, DataCeutics; Patric Genyn, Janssen Pharmaceuticals
Size: 186 Kb Keywords:  Standardized, Data, Model, CDISC, submission, sdm, crt

 Various Techniques for Processing CDISC ODM XML
  Chris Olinger, ThotWave Technologies
Size: 43 Kb Keywords:  CDISC, xml

 It's Easy If You Know How: Importing, Processing, and Exporting CDISC XML with SAS®
  Michael Palmer, Zurich Biostatistics, Inc.
Size: 142 Kb Keywords:  cdisc, xml, odm, sdm, tekoa, xmlmap

PharmaSUG 2001

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

Powered by SAS®. SAS® and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. Copyright © 2005 Lex Jansen. All rights reserved.