Conversion of Company Standard Trial Data to SDTM
|
|
|
- Madlyn Ferguson
- 5 years ago
- Views:
Transcription
1 Conversion of Company Standard Trial Data to SDTM CDISC Italian-Speaking User Group Meeting Milan, Italy March 6, 2009 Jennifer Lin, Niki Molnar Novartis Vaccines
2 Agenda Our Clinical Data Management Environment Major Transformation Decisions SDTM Conversion Tool Mapping of Non-Standard Data Validation Trial Metadata Resources Used
3 Our Clinical Data Management (CDM) Environment Novartis Vaccines division separate from Pharma and Diagnostics relatively small group (e.g., 17 statistical programmers) existed for many years as Chiron
4 Our Clinical Data Management (CDM) Environment Vaccines studies are characterized by: relatively small number of data domains similar data collection profiles from study to study
5 Our Clinical Data Management (CDM) Environment: Data Flow Inform or Clintrial Database NVS Datasets TFLs
6 Our Clinical Data Management (CDM) Environment In our favor: strong standard developed over 10 years (NVS) only approximately 12 panels to convert not too much non-standard per study most of the decision-makers located at the same site
7 Our Clinical Data Management (CDM) Environment Challenges: few people lean budget lots of applications relying on NVS format too many other urgent priorities = changing a wheel on a moving express train!
8 Major Transformation Decisions 1. Focus on generic transformation tool first can produce SDTM datasets without requiring change to any other applications can transform legacy data for eventual data warehouse
9 Major Transformation Decisions 2. Use in-house SAS programmer develop in-house CDISC expertise application can be completely customized to our needs skilled SAS programmer had time budget was lean
10 Major Transformation Decisions: Data Flow Inform or Clintrial Database NVS Datasets SDTM Datasets TFLs
11 Major Transformation Decisions: Data Flow Inform or Clintrial Database NVS Datasets SDTM Datasets TFLs SDTM Conversion Tool
12 SDTM Conversion Tool Web application Converts 12 NVS panels into 17 CDISC domains ADVERSE CMED COMMENTS DEATH DEMOG IMMUN LABSEDT MEDHX POSTINJ PREGRPT PREGFU STUDYTER AE, SUPPAE CM, SUPPCM CO DS, SUPPDS DM, SUPPDM, DS, SC EX, SUPPEX LB, SUPPLB MH, SUPPMH AE, SUPPAE, VS SUPPDM SUPPDM DS, SUPPDS
13 SDTM Conversion Tool: Prerequisites Input datasets must be located in development study folder (i.e., \DEVEL\SSD in the folder path)
14 SDTM Conversion Tool Leverages the fact that every study has a standard folder structure in Windows: E:\PROJNAME\STUDYNAME\PURPOSE\VALIDATION_LE VEL\FILETYPE PURPOSE: e.g., 03MAY09_Analysis VALIDATION_LEVEL: DEVEL, QA, PROD FILETYPE: e.g., SSD, SAS, SDTM
15 SDTM Conversion Tool: User Input
16 SDTM Conversion Tool: User Input
17 SDTM Conversion Tool: User Input
18 SDTM Conversion Tool: User Input
19 SDTM Conversion Tool: Output #1. DEVEL\SDTM output
20 SDTM Conversion Tool: Output #1. DEVEL\SDTM output #2. SAS code for generating SDTM in DEVEL\SAS
21 SDTM Conversion Tool: Output #1. DEVEL\SDTM output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata Listing
22 SDTM Conversion Tool: Output #1. DEVEL\SDTM output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata Listing #4. Discrepancy Listing
23 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata Listing #4. Discrepancy Listing
24 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing
25 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing
26 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing
27 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing
28 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing Promote all programs to PROD after validation Run cdisc_run_all_sdtm.sas after promotion to generate all sdtm datasets in PROD\SDTM
29 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing
30 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing A listing of the standard mappings conducted by the SDTM Conversion Tool.
31 SDTM Conversion Tool: Output
32 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing
33 SDTM Conversion Tool: Output #1. DEVEL\SDTM Output #2. SAS code for generating SDTM in DEVEL\SAS #3. Metadata listing #4. Discrepancy Listing A listing of the discrepancies, i.e., the non-standard panels or variables that could not be mapped by the SDTM Transformation Tool.
34 SDTM Conversion Tool: Output
35 SDTM Conversion Tool: Output
36 SDTM Conversion Tool: Output
37 SDTM Conversion Tool: Process
38 SDTM Conversion Tool Not handled by the SDTM Conversion Tool: Mapping of non-standard data Validation Trial Design Data (e.g., number of visits, phase, milestones)
39 Mapping of Non-Standard Data Identified by discrepancy listing Specs to be written by the Statistical Programmer, and signed off by the Study Statistician Write the code! New panel: cdisc_mk_sdtm_surghx.sas Preproc: cdisc_preproc_demog.sas Postproc:cdisc_postproc_demog.sas
40 Validation Validate all SDTM Datasets against NVS datasets OQ / Peer Review Budget extra validation time
41 Trial Design Data Part of SDTM submission Trial Specific Data, e.g., protocol title, trial phase, trial blinding schema Initially to be manually collected Plan to automate this
42 SDTM Conversion Tool Resources Programmed using SAS 9.1 Windows and SAS/INTRNET Specifications completed in 3 mos. with 4 people meeting 2x per week for 1 hour Programming completed by 1 programmer in 1 year working in between many other projects Validation has not started
43 Questions?
2 nd ehs Workshop, CC-IN2P3 14 th October 2015, Lyon,
2 nd ehs Workshop, CC-IN2P3 14 th October 2015, Lyon, CDISC transmart master tree via transmart clinical study tree. Work Package Number: WP3&WP4 Dorina BRATFALEAN, CDISC Adriano BARBOSA DA SILVA, LCSB
Legacy to SDTM Conversion Workshop: Tools and Techniques
Legacy to SDTM Conversion Workshop: Tools and Techniques Mike Todd President Nth Analytics Legacy Data Old studies never die Legacy studies are often required for submissions or pharmacovigilence. Often
Hanming Tu, Accenture, Berwyn, USA
Hanming Tu, Accenture, Berwyn, USA Agenda Issue Statement Create Mapping Build Reusable Codes Define Repeatable Workflow Check compliance Conclusion Copyright 2016 Accenture. All rights reserved. 2 Issue
AUTOMATED CREATION OF SUBMISSION-READY ARTIFACTS SILAS MCKEE
AUTOMATED CREATION OF SUBMISSION-READY ARTIFACTS SILAS MCKEE AGENDA 1. Motivation 2. Automation Overview 3. Architecture 4. Validating the System 5. Pilot Study Results 6. Future State Copyright 2012-2017
Implementing CDISC Using SAS. Full book available for purchase here.
Implementing CDISC Using SAS. Full book available for purchase here. Contents About the Book... ix About the Authors... xv Chapter 1: Implementation Strategies... 1 The Case for Standards... 1 Which Models
From Implementing CDISC Using SAS. Full book available for purchase here. About This Book... xi About The Authors... xvii Acknowledgments...
From Implementing CDISC Using SAS. Full book available for purchase here. Contents About This Book... xi About The Authors... xvii Acknowledgments... xix Chapter 1: Implementation Strategies... 1 Why CDISC
CDASH Standards and EDC CRF Library. Guang-liang Wang September 18, Q3 DCDISC Meeting
CDASH Standards and EDC CRF Library Guang-liang Wang September 18, 2014 2014 Q3 DCDISC Meeting 1 Disclaimer The content of this presentation does not represent the views of my employer or any of its affiliates.
Automated Creation of Submission-Ready Artifacts Silas McKee, Accenture, Pennsylvania, USA Lourdes Devenney, Accenture, Pennsylvania, USA
Paper DH06 Automated Creation of Submission-Ready Artifacts Silas McKee, Accenture, Pennsylvania, USA Lourdes Devenney, Accenture, Pennsylvania, USA ABSTRACT Despite significant progress towards the standardization
Optimization of the traceability when applying an ADaM Parallel Conversion Method
SI04 Optimization of the traceability when applying an ADaM Parallel Conversion Method Roxane Debrus ADaM Conversion Process Agenda %LIB_QC_contents_html %adam_sdtm_compa Conclusion ADaM Conversion Process
Paper FC02. SDTM, Plus or Minus. Barry R. Cohen, Octagon Research Solutions, Wayne, PA
Paper FC02 SDTM, Plus or Minus Barry R. Cohen, Octagon Research Solutions, Wayne, PA ABSTRACT The CDISC Study Data Tabulation Model (SDTM) has become the industry standard for the regulatory submission
Reporting & Visualisation : D un Dun standard maison au format CDISC 02/02/2016 CDISC GUF 1
Reporting & Visualisation : D un Dun standard maison au format CDISC Jérémy MAMBRINI Florence WAGER 02/02/2016 CDISC GUF 1 Contents CDISC Implementation ti at SERVIER Reporting & Visualisation using CDISC
How a Metadata Repository enables dynamism and automation in SDTM-like dataset generation
Paper DH05 How a Metadata Repository enables dynamism and automation in SDTM-like dataset generation Judith Goud, Akana, Bennekom, The Netherlands Priya Shetty, Intelent, Princeton, USA ABSTRACT The traditional
How to write ADaM specifications like a ninja.
Poster PP06 How to write ADaM specifications like a ninja. Caroline Francis, Independent SAS & Standards Consultant, Torrevieja, Spain ABSTRACT To produce analysis datasets from CDISC Study Data Tabulation
Study Data Reviewer s Guide Completion Guideline
Study Data Reviewer s Guide Completion Guideline 22-Feb-2013 Revision History Date Version Summary 02-Nov-2012 0.1 Draft 20-Nov-2012 0.2 Added Finalization Instructions 10-Jan-2013 0.3 Updated based on
Best Practices for E2E DB build process and Efficiency on CDASH to SDTM data Tao Yang, FMD K&L, Nanjing, China
PharmaSUG China 2018 - Paper 73 Best Practices for E2E DB build process and Efficiency on CDASH to SDTM data Tao Yang, FMD K&L, Nanjing, China Introduction of each phase of the trial It is known to all
From ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials
PhUSE 2014 Paper PP05 From ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials Alexandre Mathis, Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd., Allschwil, Switzerland
SAS offers technology to facilitate working with CDISC standards : the metadata perspective.
SAS offers technology to facilitate working with CDISC standards : the metadata perspective. Mark Lambrecht, PhD Principal Consultant, Life Sciences SAS Agenda SAS actively supports CDISC standards Tools
Dataset-XML - A New CDISC Standard
Dataset-XML - A New CDISC Standard Lex Jansen Principal Software Developer @ SAS CDISC XML Technologies Team Single Day Event CDISC Tools and Optimization September 29, 2014, Cary, NC Agenda Dataset-XML
Programming checks: Reviewing the overall quality of the deliverables without parallel programming
PharmaSUG 2016 Paper IB04 Programming checks: Reviewing the overall quality of the deliverables without parallel programming Shailendra Phadke, Baxalta US Inc., Cambridge MA Veronika Csom, Baxalta US Inc.,
PhUSE Paper SD09. "Overnight" Conversion to SDTM Datasets Ready for SDTM Submission Niels Mathiesen, mathiesen & mathiesen, Basel, Switzerland
Paper SD09 "Overnight" Conversion to SDTM Datasets Ready for SDTM Submission Niels Mathiesen, mathiesen & mathiesen, Basel, Switzerland ABSTRACT This demonstration shows how legacy data (in any format)
Common Programming Errors in CDISC Data
ABSTRACT PharmaSUG 2017 - Paper DS15 Common Programming Errors in CDISC Data Sergiy Sirichenko, Pinnacle 21 Data in standardized format is now a required part of regulatory submissions. CDISC standards
CBER STUDY DATA STANDARDS UPDATE
CBER STUDY DATA STANDARDS UPDATE Lisa Lin, MBA Study Data Standards Manager Office of the Director Center for Biologics Evaluation and Research U.S. Food & Drug Administration PhUSE US Connect Raleigh,
Cost-Benefit Analysis of Retrospective vs. Prospective Data Standardization
Cost-Benefit Analysis of Retrospective vs. Prospective Data Standardization Vicki Seyfert-Margolis, PhD Senior Advisor, Science Innovation and Policy Food and Drug Administration IOM Sharing Clinical Research
Managing your metadata efficiently - a structured way to organise and frontload your analysis and submission data
Paper TS06 Managing your metadata efficiently - a structured way to organise and frontload your analysis and submission data Kirsten Walther Langendorf, Novo Nordisk A/S, Copenhagen, Denmark Mikkel Traun,
Improving CDISC SDTM Data Quality & Compliance Right from the Beginning
Improving CDISC Data Quality & Compliance Right from the Beginning Bharat Chaudhary, Cytel Padamsimh Balekundri, Cytel Session CD08 PhUSE 2015, Vienna Agenda Background Overview: Development The Problem:
Step Up Your ADaM Compliance Game Ramesh Ayyappath & Graham Oakley
Step Up Your ADaM Compliance Game Ramesh Ayyappath & Graham Oakley Accountability & Delivery Collaboration Partnership Integrity Agenda v Regulatory Requirement v Current Situation v iace-toolbox v 3 Step
Metadata and ADaM.
Metadata and ADaM 1 Disclaimer Any views or opinions presented in this presentation are solely those of the author and do not necessarily represent those of the company. 2 Agenda Introduction of ADaM Metadata
The application of SDTM in a disease (oncology)-oriented organization
Paper CD01 The application of SDTM in a disease (oncology)-oriented organization Angelo Tinazzi, Alessandro Cattaneo, Enrica Paschetto, Sonia Colombini SENDO-Tech S.r.l., Milan, Italy ABSTRACT Applying
The Wonderful World of Define.xml.. Practical Uses Today. Mark Wheeldon, CEO, Formedix DC User Group, Washington, 9 th December 2008
The Wonderful World of Define.xml.. Practical Uses Today Mark Wheeldon, CEO, Formedix DC User Group, Washington, 9 th December 2008 Agenda Introduction to Formedix What is Define.xml? Features and Benefits
Improving Metadata Compliance and Assessing Quality Metrics with a Standards Library
PharmaSUG 2018 - Paper SS-12 Improving Metadata Compliance and Assessing Quality Metrics with a Standards Library Veena Nataraj, Erica Davis, Shire ABSTRACT Establishing internal Data Standards helps companies
CDISC SDTM and ADaM Real World Issues
CDISC SDTM and ADaM Real World Issues Washington DC CDISC Data Standards User Group Meeting Sy Truong President MXI, Meta-Xceed, Inc. http://www.meta-x.com Agenda CDISC SDTM and ADaM Fundamentals CDISC
PhUSE US Connect 2019
PhUSE US Connect 2019 Paper SI04 Creation of ADaM Define.xml v2.0 Using SAS Program and Pinnacle 21 Yan Lei, Johnson & Johnson, Spring House, PA, USA Yongjiang Xu, Johnson & Johnson, Spring House, PA,
SDTM Implementation Guide Clear as Mud: Strategies for Developing Consistent Company Standards
Paper CD02 SDTM Implementation Guide Clear as Mud: Strategies for Developing Consistent Company Standards Brian Mabe, UCB Biosciences, Raleigh, USA ABSTRACT Many pharmaceutical companies are now entrenched
Introduction to ADaM and What s new in ADaM
Introduction to ADaM and What s new in ADaM Italian CDISC UN Day - Milan 27 th October 2017 Silvia Faini Principal Statistical Programmer CROS NT - Verona ADaM Purpose Why are standards needed in analysis
DIA 11234: CDER Data Standards Common Issues Document webinar questions
Q: What is the preferred data definition format for ADaM analysis data, define.xml or define.pdf? 1 ADaM Define File Q: The CRTDDS does not describe how to submit a define.xml for ADaM. Does CDER expect
The New SDTMIG What s Different from Previous Versions
1 The New SDTMIG 3.1.4 What s Different from Previous Versions Presented by Dan Godoy (SDS Team Co-Lead) 2 Agenda Background Progress-to-Date SDTM 3.1.4 - What s Different? Key Features & Examples Q&A
SAS Clinical Data Integration Server 2.1
SAS Clinical Data Integration Server 2.1 User s Guide Preproduction Documentation THIS DOCUMENT IS A PREPRODUCTION DRAFT AND IS PROVIDED BY SAS INSTITUTE INC. ON AN AS IS BASIS WITHOUT WARRANTY OF ANY
AUTOMATED SDTM CREATION AND DISCREPANCY DETECTION JOBS: THE NUMBERS TELL THE TALE. Joris De Bondt PhUSE Conference Oct 2014
AUTOMATED SDTM CREATION AND DISCREPANCY DETECTION JOBS: THE NUMBERS TELL THE TALE Joris De Bondt PhUSE Conference 2014 12-15 Oct 2014 OUTLINE n Setting the scene SGS Conversion Center SDTM data sources
Advantages of a real end-to-end approach with CDISC standards
Advantages of a real end-to-end approach with CDISC standards Dr. Philippe Verplancke CEO XClinical GmbH 26th Annual EuroMeeting 25-27 March 2014 ACV, Vienna Austria Disclaimer The views and opinions expressed
SAS Clinical Data Integration 2.4
SAS Clinical Data Integration 2.4 User s Guide SAS Documentation The correct bibliographic citation for this manual is as follows: SAS Institute Inc. 2013. SAS Clinical Data Integration 2.4: User's Guide.
Going Against the Flow: Backmapping SDTM Data
Paper DH05 Going Against the Flow: Backmapping SDTM Data Pantaleo Nacci, Novartis Vaccines & Diagnostics Srl, Siena, Italy ABSTRACT Novartis Vaccines has embarked on a multi-year project to remap all available
Managing CDISC version changes: how & when to implement? Presented by Lauren Shinaberry, Project Manager Business & Decision Life Sciences
1 Managing CDISC version changes: how & when to implement? Presented by Lauren Shinaberry, Project Manager Business & Decision Life Sciences 2 Content Standards Technical Standards SDTM v1.1 SDTM IG v3.1.1
An Alternate Way to Create the Standard SDTM Domains
PharmaSUG 2018 - Paper DS-12 ABSTRACT An Alternate Way to Create the Standard SDTM Domains Sunil Kumar Pusarla, Omeros Corporation Sponsors who initiate clinical trials after 2016-12-17 are required to
Data Science Services Dirk Engfer Page 1 of 5
Page 1 of 5 Services SAS programming Conform to CDISC SDTM and ADaM within clinical trials. Create textual outputs (tables, listings) and graphical output. Establish SAS macros for repetitive tasks and
IS03: An Introduction to SDTM Part II. Jennie Mc Guirk
IS03: An Introduction to SDTM Part II Jennie Mc Guirk SDTM Framework 1. Where should the data go? 3. What is the minimum information needed? 2. What type of information should it contain? SDTM Framework:
Data Standards with and without CDISC
Paper FC02 Data Standards with and without CDISC Sy Truong, Meta-Xceed, Inc, Fremont, CA ABSTRACT Data standards can make data and its associated programs more portable. Team members who work with the
Advanced Data Visualization using TIBCO Spotfire and SAS using SDTM. Ajay Gupta, PPD
Advanced Data Visualization using TIBCO Spotfire and SAS using SDTM Ajay Gupta, PPD INTRODUCTION + TIBCO Spotfire is an analytics and business intelligence platform, which enables data visualization in
Dealing with changing versions of SDTM and Controlled Terminology (CT)
CDISC UK Network Breakout session Notes 07/06/16 Afternoon Session 1: Dealing with changing versions of SDTM and Controlled Terminology (CT) How do people manage this? Is this managed via a sponsor Standards
Considerations on creation of SDTM datasets for extended studies
13/May/2016 As one of the activities of CDISC Japan User Group (CJUG), a small group, "Extension study team" was organized in 2015. The team discussed what kind of approach works better for SDTM creation
PharmaSUG 2014 PO16. Category CDASH SDTM ADaM. Submission in standardized tabular form. Structure Flexible Rigid Flexible * No Yes Yes
ABSTRACT PharmaSUG 2014 PO16 Automation of ADAM set Creation with a Retrospective, Prospective and Pragmatic Process Karin LaPann, MSIS, PRA International, USA Terek Peterson, MBA, PRA International, USA
PharmaSUG Paper PO21
PharmaSUG 2015 - Paper PO21 Evaluating SDTM SUPP Domain For AdaM - Trash Can Or Buried Treasure Xiaopeng Li, Celerion, Lincoln, NE Yi Liu, Celerion, Lincoln, NE Chun Feng, Celerion, Lincoln, NE ABSTRACT
Leveraging Study Data Reviewer s Guide (SDRG) in Building FDA s Confidence in Sponsor s Submitted Datasets
PharmaSUG 2017 - Paper SS09 Leveraging Study Data Reviewer s Guide (SDRG) in Building FDA s Confidence in Sponsor s Submitted Datasets Xiangchen (Bob) Cui, Min Chen, and Letan (Cleo) Lin, Alkermes Inc.,
Standardising The Standards The Benefits of Consistency
Paper DH06 Standardising The Standards The Benefits of Consistency Nathan James, Roche Products Ltd., Welwyn Garden City, UK ABSTRACT The introduction of the Study Data Tabulation Model (SDTM) has had
Customer oriented CDISC implementation
Paper CD10 Customer oriented CDISC implementation Edelbert Arnold, Accovion GmbH, Eschborn, Germany Ulrike Plank, Accovion GmbH, Eschborn, Germany ABSTRACT The Clinical Data Interchange Standards Consortium
An Introduction to Analysis (and Repository) Databases (ARDs)
An Introduction to Analysis (and Repository) TM Databases (ARDs) Russell W. Helms, Ph.D. Rho, Inc. Chapel Hill, NC RHelms@RhoWorld.com www.rhoworld.com Presented to DIA-CDM: Philadelphia, PA, 1 April 2003
ABSTRACT INTRODUCTION WHERE TO START? 1. DATA CHECK FOR CONSISTENCIES
Developing Integrated Summary of Safety Database using CDISC Standards Rajkumar Sharma, Genentech Inc., A member of the Roche Group, South San Francisco, CA ABSTRACT Most individual trials are not powered
SAS Clinical Data Integration 2.6
SAS Clinical Data Integration 2.6 User s Guide SAS Documentation The correct bibliographic citation for this manual is as follows: SAS Institute Inc. 2015. SAS Clinical Data Integration 2.6: User's Guide.
PhUSE EU Connect Paper PP15. Stop Copying CDISC Standards. Craig Parry, SyneQuaNon, Diss, England
Paper PP15 Abstract Stop Copying CDISC Standards Craig Parry, SyneQuaNon, Diss, England We repeatedly see repositories which require a large amount of front loading, a lot of duplicating of the Clinical
Lex Jansen Octagon Research Solutions, Inc.
Converting the define.xml to a Relational Database to enable Printing and Validation Lex Jansen Octagon Research Solutions, Inc. Leading the Electronic Transformation of Clinical R&D PhUSE 2009, Basel,
Johannes Ulander. Standardisation and Harmonisation Specialist S-Cubed. PhUSE SDE Beerse,
Towards better data Johannes Ulander Standardisation and Harmonisation Specialist S-Cubed PhUSE SDE Beerse, 2017-11-28 Agenda What is data? Current state of submissions Introduction to linked data and
Study Data Reviewer s Guide
Revision History Date Study Data Reviewer s Guide Completion Guideline: Nonclinical (nnsdrg) Version Summary V1.1 03 March 2016 1.0 First Public Version: posted for Public Comment 1.1 Update from Public
IBIS. Case Study: Image Data Management System. IBISimg at Novartis using Oracle Database 11g Multimedia DICOM
IMPACT BUSINESS INFORMATION SOLUTIONS, INC. IBIS Case Study: Image Data Management System IBISimg at Novartis using Oracle Database 11g Multimedia DICOM Agenda Introduction Drug Development Overview Imaging
Creating a Patient Profile using CDISC SDTM Marc Desgrousilliers, Clinovo, Sunnyvale, CA Romain Miralles, Clinovo, Sunnyvale, CA
Creating a Patient Profile using CDISC SDTM Marc Desgrousilliers, Clinovo, Sunnyvale, CA Romain Miralles, Clinovo, Sunnyvale, CA ABSTRACT CDISC SDTM data is the standard format requested by the FDA for
Standardizing FDA Data to Improve Success in Pediatric Drug Development
Paper RA01 Standardizing FDA Data to Improve Success in Pediatric Drug Development Case Study: Harmonizing Hypertensive Pediatric Data across Sponsors using SAS and the CDISC Model Julie Maddox, SAS Institute,
FDA Study Data Technical Conformance Guide v4.2
FDA Study Data Technical Conformance Guide v4.2 November 2018 Helena Sviglin, MPH Regulatory Information Specialist Computational Science Center CDER Topics Covered in this Webinar New content for v4.2
Sandra Minjoe, Accenture Life Sciences John Brega, PharmaStat. PharmaSUG Single Day Event San Francisco Bay Area
Sandra Minjoe, Accenture Life Sciences John Brega, PharmaStat PharmaSUG Single Day Event San Francisco Bay Area 2015-02-10 What is the Computational Sciences Symposium? CSS originally formed to help FDA
Submission-Ready Define.xml Files Using SAS Clinical Data Integration Melissa R. Martinez, SAS Institute, Cary, NC USA
PharmaSUG 2016 - Paper SS12 Submission-Ready Define.xml Files Using SAS Clinical Data Integration Melissa R. Martinez, SAS Institute, Cary, NC USA ABSTRACT SAS Clinical Data Integration simplifies the
Comparison of FDA and PMDA Requirements for Electronic Submission of Study Data
Comparison of FDA and PMDA Requirements for Electronic Submission of Study Data Monika Kawohl Statistical Programming Accovion CDISC GSUG Meeting 15-Sep-2015 1 References FDA Website: Study Data Standards
How to review a CRF - A statistical programmer perspective
Paper DH07 How to review a CRF - A statistical programmer perspective Elsa Lozachmeur, Novartis Pharma AG, Basel, Switzerland ABSTRACT The design of the Case Report Form (CRF) is critical for the capture
Converting Data to the SDTM Standard Using SAS Data Integration Studio
Paper RA01 Converting Data to the SDTM Standard Using SAS Data Integration Studio Barry R. Cohen, Octagon Research Solutions, Wayne, PA ABSTRACT The CDISC Study Data Tabulation Model (SDTM) is becoming
Riepilogo e Spazio Q&A
Riepilogo e Spazio Q&A CDISC Italian User Network Day 27 Ottobre 2017 Angelo Tinazzi (Cytel) - Silvia Faini (CROS NT) E3C members 2 Agenda ADaM key list Bad & Good ADaM...More... Spazio Q&A ADaM Key List
SDTM Automation with Standard CRF Pages Taylor Markway, SCRI Development Innovations, Carrboro, NC
PharmaSUG 2016 - Paper PO21 SDTM Automation with Standard CRF Pages Taylor Markway, SCRI Development Innovations, Carrboro, NC ABSTRACT Much has been written about automatically creating outputs for the
Edwin Ponraj Thangarajan, PRA Health Sciences, Chennai, India Giri Balasubramanian, PRA Health Sciences, Chennai, India
Paper CD15 PhUSE 2016 How to handle different versions of SDTM & DEFINE generation in a Single Study? Edwin Ponraj Thangarajan, PRA Health Sciences, Chennai, India Giri Balasubramanian, PRA Health Sciences,
DCDISC Users Group. Nate Freimark Omnicare Clinical Research Presented on
DCDISC Users Group Nate Freimark Omnicare Clinical Research Presented on 2011-05-12 1 Disclaimer The opinions provided are solely those of the author and not those of the ADaM team or Omnicare Clinical
Introduction to CDASH
Introduction to CDASH Rhonda Facile, CDISC Melissa Binz, Wyeth Presented by Melissa Binz Director Central Standards Group, Wyeth 1 Introduction to the CDASH Standard Monday, March 16 2009 Welcome and Review
Now let s take a look
1 2 3 4 Manage assets across the end to end life cycle of your studies This includes forms, datasets, terminologies, files, links and more, for example: - Studies may contain the protocol, a set of Forms,
CDASH MODEL 1.0 AND CDASHIG 2.0. Kathleen Mellars Special Thanks to the CDASH Model and CDASHIG Teams
CDASH MODEL 1.0 AND CDASHIG 2.0 Kathleen Mellars Special Thanks to the CDASH Model and CDASHIG Teams 1 What is CDASH? Clinical Data Acquisition Standards Harmonization (CDASH) Standards for the collection
Standards Metadata Management (System)
Standards Metadata Management (System) Kevin Lee, MarkLogic COPYRIGHT 2015 MARKLOGIC CORPORATION. ALL RIGHTS RESERVED. Agenda Regulatory Requirement on Clinical Trial Standards(i.e., CDISC and ectd) Standards
Robust approach to create Define.xml v2.0. Vineet Jain
Robust approach to create Define.xml v2.0 Vineet Jain DEFINE SYSTEM GOALS Generic Powerful Reliable Integrable Efficient Works across SDTM, ADaM & SEND Create define.xml, annotated CRF & define.pdf Create
PharmaSUG Paper CD16
PharmaSUG2010 - Paper CD16 Checking for SDTM Compliance: The Need for Human Involvement Fred Wood and Adrienne Boyance Data Standards Consulting Octagon Research Solutions, Wayne, PA ABSTRACT An increasing
Data Standardisation, Clinical Data Warehouse and SAS Standard Programs
Paper number: AD03 Data Standardisation, Clinical Data Warehouse and SAS Standard Programs Jean-Marc Ferran, Standardisation Manager, MSc 1 Mikkel Traun, Functional Architect, MSc 1 Pia Hjulskov Kristensen,
Out-of-the-box %definexml
Out-of-the-box %definexml Just a Simple SAS Macro PhUSE / October 2016 / Katja Glaß Agenda Introduction Getting Started %DefineXML Collaborate Summary Page 2 DefineXML Katja Glaß 11. October 2016 Introduction
The Submission Data File System Automating the Creation of CDISC SDTM and ADaM Datasets
Paper AD-08 The Submission Data File System Automating the Creation of CDISC SDTM and ADaM Datasets Marcus Bloom, Amgen Inc, Thousand Oaks, CA David Edwards, Amgen Inc, Thousand Oaks, CA ABSTRACT From
Automation of SDTM Programming in Oncology Disease Response Domain Yiwen Wang, Yu Cheng, Ju Chen Eli Lilly and Company, China
ABSTRACT Study Data Tabulation Model (SDTM) is an evolving global standard which is widely used for regulatory submissions. The automation of SDTM programming is essential to maximize the programming efficiency
Challenges with the interpreta/on of CDISC - Who can we trust?
Challenges with the interpreta/on of CDISC - Who can we trust? Linda Palm Simonsson linda.simonsson@i- mind.se CD01 #PhUSE14 - London 2014-10- 13 Abstract Many smaller companies have none or very linle
Hands-On ADaM ADAE Development Sandra Minjoe, Accenture Life Sciences, Wayne, Pennsylvania Kim Minkalis, Accenture Life Sciences, Wayne, Pennsylvania
PharmaSUG 2014 - Paper HT03 Hands-On ADaM ADAE Development Sandra Minjoe, Accenture Life Sciences, Wayne, Pennsylvania Kim Minkalis, Accenture Life Sciences, Wayne, Pennsylvania ABSTRACT The Analysis Data
Step by Step to PROC CDISC and More
Step by Step to PROC CDISC and More Sy Truong, Meta Xceed, Inc, Milpitas, CA ABSTRACT There are many crucial steps that are required during the implementation of the CDISC data models. This paper presents
Beyond OpenCDISC: Using Define.xml Metadata to Ensure End-to-End Submission Integrity. John Brega Linda Collins PharmaStat LLC
Beyond OpenCDISC: Using Define.xml Metadata to Ensure End-to-End Submission Integrity John Brega Linda Collins PharmaStat LLC Topics Part 1: A Standard with Many Uses Status of the Define.xml Standard
The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards Maggie Ci Jiang, Teva Pharmaceuticals, Great Valley, PA
PharmaSUG 2017 - Paper DS23 The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards Maggie Ci Jiang, Teva Pharmaceuticals, Great Valley, PA ABSTRACT Since FDA released the Analysis
CDISC Implementation Step by Step: A Real World Example
HW07 CDISC Implementation Step by Step: A Real World Example Sy Truong, Meta-Xceed, Inc., Milpitas, CA Patricia Gerend, Genentech, Inc., South San Francisco, CA ABSTRACT Implementation of the CDISC SDTM
SDTM Attribute Checking Tool Ellen Xiao, Merck & Co., Inc., Rahway, NJ
PharmaSUG2010 - Paper CC20 SDTM Attribute Checking Tool Ellen Xiao, Merck & Co., Inc., Rahway, NJ ABSTRACT Converting clinical data into CDISC SDTM format is a high priority of many pharmaceutical/biotech
SDTM-ETL TM. New features in version 1.6. Author: Jozef Aerts XML4Pharma July SDTM-ETL TM : New features in v.1.6
SDTM-ETL TM New features in version 1.6 Author: Jozef Aerts XML4Pharma July 2011 p.1/14 Table of Contents Implementation of SEND v.3.0 final...3 Automated creation of the RELREC dataset and records...4
Material covered in the Dec 2014 FDA Binding Guidances
Accenture Accelerated R&D Services Rethink Reshape Restructure for better patient outcomes Sandra Minjoe Senior ADaM Consultant Preparing ADaM and Related Files for Submission Presentation Focus Material
A SDTM Legacy Data Conversion
Paper DS01 A SDTM Legacy Data Conversion Markus Stoll, German CDISC UN Lead Member, Muehltal, Germany Laura Phelan, Cytel Inc., Paris, France Angelo Tinazzi, Cytel Inc., Geneva, Switzerland ABSTRACT We
Experience of electronic data submission via Gateway to PMDA
PharmaSUG 2018 - Paper EP-21 ABSTRACT Experience of electronic data submission via Gateway to PMDA Iori Sakakibara, Kumiko Kimura, Amgen Astellas BioPharma K.K. and Laurence Carpenter, Amgen Ltd PMDA started
PharmaSUG Paper DS06 Designing and Tuning ADaM Datasets. Songhui ZHU, K&L Consulting Services, Fort Washington, PA
PharmaSUG 2013 - Paper DS06 Designing and Tuning ADaM Datasets Songhui ZHU, K&L Consulting Services, Fort Washington, PA ABSTRACT The developers/authors of CDISC ADaM Model and ADaM IG made enormous effort
EDC integrations. Rob Jongen Integration Technology & Data Standards
EDC integrations Rob Jongen Integration Technology & Data Standards Past, Present and Future Past (10 years back) Few sources, all on paper Source data copied on paper CRF Data entry from CRF to clinical
ODM The Operational Efficiency Model: Using ODM to Deliver Proven Cost and Time Savings in Study Set-up
ODM The Operational Efficiency Model: Using ODM to Deliver Proven Cost and Time Savings in Study Set-up Mark Wheeldon, CEO, Formedix Bay Area User Group Meeting, 15 th July 2010 Who are we? Proven Business
A Taste of SDTM in Real Time
A Taste of SDTM in Real Time Changhong Shi, Merck & Co., Inc., Rahway, NJ Beilei Xu, Merck & Co., Inc., Rahway, NJ ABSTRACT The Study Data Tabulation Model (SDTM) is a Clinical Data Interchange Standards
One Project, Two Teams: The Unblind Leading the Blind
ABSTRACT PharmaSUG 2017 - Paper BB01 One Project, Two Teams: The Unblind Leading the Blind Kristen Reece Harrington, Rho, Inc. In the pharmaceutical world, there are instances where multiple independent