OpenCDISC Validator 1.4 What s New?
|
|
- Sophia Thornton
- 6 years ago
- Views:
Transcription
1 OpenCDISC Validator 1.4 What s New? Bay Area CDISC Implementation Network 23 May 2013 David Borbas Sr Director, Data Management Jazz Pharmaceuticals, Inc.
2 Disclaimers The opinions expressed in this presentation are not the official views or policies of Jazz Pharmaceuticals, Inc. 2
3 Topics What is Open CDISC? Why is it important? View of the FDA use of OpenCDISC Validator Using the application Understanding the Validation Reports 3
4 Open CDISC Open Source application Java and xml Can check/validate SDTM, ADaM, SEND and Define.xml files Generate Define.xml limited Based on published standards e.g. Draft Janus validation rules and user suggested rules Currently used in the FDA submission checking process 4
5 FDA Review Past, Present & Future FDA Review Environment Sponsor Validation Review Past WebSDM Sponsor Data in ectd format for NDA or snda FDA Electronic Document Room Servers Present Open CDISC Validator Future 2013? FDA Review Tools WebSDM/ Empirica, jreview, SAS/JMP Open CDISC Validator Data Fit JANUS Data Views Future Additional Data Visualization Tools - Evaluation of JMP Clinical, ireview, Spotfire 5
6 Open CDISC Application Website location PC specs Minimum RAM 1 GB Any Java capable PC Java version required >= ver 1.5 run check-java.bat file to confirm version Command line option available 6
7 What is New in Version Support for SDTM v1.3 and SDTMIG v3.1.3 SDTMIG amend 1 removed upgraded to SDTMIG Controlled Terminology Added ability to specify CDISC Controlled Terminology versions ADaM and SEND validation Added ability to specify SEND or ADaM validation types 7
8 What is New in Version New SDTM Validation Rules Validator 1.3 Rule Count = 227 Validator 1.4 Rule Count = 360 Updates to SDTM, SEND and ADaM rules Better support for split datasets Specify MedDRA/CDISC Controlled Terminology versions Specify SEND/ADaM validation types 8
9 GUI Screen View - 1 9
10 Directories config Note: Version 1.4 on the right panel in this and all following slides 10
11 Directories - data 11
12 Directories cdisc New directory Not present in ver
13 Directories cdisc/sdtm Terminology Directories 13
14 Directories
15 Terminology Files Updating Terminology files Create a new directory Name with terminology version date newly added after the OpenCDISC validator ver 1.4 was downloaded 15
16 Updated Terminology File added! 16
17 MedDRA -1 Same process as Terminology versions 17
18 MedDRA - 2 Add the MedDRA ascii files for each version to a directory 18
19 MedDRA versions in the GUI 19
20 Using MedDRA with Define.xml OpenCDISC Validator is programmed to use the MedDRA Version that is specified in the define.xml file. So running validation with a define.xml file will support checking against that MedDRA version. NOTE: You cannot override the MedDRA version specified in the define.xml file by selecting a different version of MedDRA from the Options menu of the GUI. If you do not use a define.xml file OR the define file does not specify the MedDRA version you can use a drop down list choice during the Options selection phase of the MedDRA GUI. 20
21 Running OpenCDISC Validator - GUI Start in the main Validator directory where you unzipped the files and find the file client.bat. This is the file that will start the GUI and for most users will be the easiest way to run validation checking of CDISC Standards files. Select client.bat to start the program. 21
22 Client Application - Options Validate (data) or Generate Define.xml Standard Choices SDTM AdaM Define.xml SEND Custom (Tabular) Source / Input files: select location SAS V5 Transport Delimited (CSV, Tab etc) Configuration Depends on Standard choice Define.xml optional Reports Report settings link: use to customize report filename etc 22
23 Viewing the Validation Report - 1 Once the validation is complete you will see a brief summary of the validation statistics 23
24 Viewing the Validation Report - 2 Once the validation is complete you have three options View the validation report - click the View Report button OR Start another validation or define generation activity - click the New Session button OR Exit the GUI application by clicking the File - > Exit or the close window red x and confirm the exit. 24
25 Validation Report - 1 At the end of a validation run you can choose to view the report. When you select this option the spreadsheet file will open. You can review the report, save the file in another location, or attach to an . Since version 1.3 the Excel report has been revised to improve readability. The issues summary tab is now grouped by domain The terminology issues are collapsed into instances of distinct terms. This reduces the size of the details tab. 25
26 Validation Report - 2 Formats CSV file unlimited rows 4 tabbed Excel worksheets 1. Dataset Summary with Error counts Errors (High) Warnings (Med) Infos (Low) 2. Issue Summary by Rule ID with error counts 3. Details dataset, variables, values, rules, messages Contains the complete list of the validation findings sorted by domain name. 4. Rules Rule ID with message, description and type Report file name and headers can be input with Protocol, date, time, other text etc Useful to communicate with vendors and internal team 26
27 Validation Report - 3 The Details worksheet can be filtered and sorted to identify the individual data items you want to investigate by dataset or by rule or by type of check. There are a two characteristics of this list to highlight that will aid the interpretation of your results. 27
28 Validation Report - 4 Unique Row Findings If the finding is related to a specific row in the data then a record number will be present. And the specific variable(s) and value(s) will be identified. If character values are placed into numeric fields OR numeric values placed into text fields these will be treated as unique records in the finding list. Global Findings Controlled Terminology findings for a variable that are present across multiple records will be counted for each specific term. 28
29 Interpreting the Validation Results - 1 What Open CDISC can automate for you dataset structure var names / labels data integrity checks reference to DM subjects presence of baseline flags dates after disposition Results units consistency Terminology checks referential integrity Start date before End date Disposition references - sometimes 29
30 Interpreting the Validation Results - 2 What you still have to do dataset structure do you have the right vars per spec? custom domains data integrity baseline flags does not see 2 per subject Review Terminology flags, If a codelist is expandable is it correct? data validation more content focused right subjects right dates right codelists right testcodes 30
31 Interpreting the Validation Results - 3 False positive results may occur Lab tests without units will generate error SD0026 and SD0029 e.g. Urine Ph = 5, specific gravity Terminology Extensible codelists with non matches in the terminology file where the sponsor has added codes / values not present E.g. Oxygen Saturation as O2SAT VSTESTCD Some program bugs may generate false error messages Post to Open CDISC forum 31
32 Interpreting the Validation Results - 4 View of Validation Report 32
33 OpenCDISC Forum Feedback on this New Rule! - 1 SD variable length is too long for actual data graded as an ERROR in the AE domain Remember All Errors should be addressed and fixed if possible prior to esubmission..note, that variable length issue is not SDTM compliance. It s very specific to SAS format used for regulatory submission. 33
34 OpenCDISC reply - 2 Defining requirements for variable lengths is a very interesting and controversial topic. This week we have productive discussion on FDA/PhUSE Data Validation workgroup meeting. There are several basic and mutually exclusive needs or risks. 1. Datasets should be re-sized (not compressed!) to minimal size because (very long list of reasons, e.g., data transfer, archiving storage, analysis tools limitations, hardware limitations, etc.) 2. Variables in SAS XPORT datasets should have consistent/predefined length to avoid data truncation during data integration. There are many un-perfect and un-complete recommendations how to achieve this. E.g., --TESTCD variables lengths should be always 8 Chars. 3. Variable length should be defined by data collection process. E.g., it can be set to maximum length of value in your data collection or control terminology codelist. 34
35 Rule change 3 New Release v Note, that variable length issue is not SDTM compliance. It s very specific to SAS format used for regulatory submission. OpenCDISC validator will remove all current Variable Length related checks. Only one new Rule will be introduced. Before sending data to FDA you need to re-size you data by each variable to actual maximum value. Note, that it s needed only for actual data transfer to FDA. You can do whatever you want before this event. It s very easy to do. Profiles will be updated soon. Watch for v1.4.1 OpenCDISC Validator release in the next weeks. 35
36 Suggested Process for OpenCDISC Validator Review Setup / Parameters Confirm SDTM Version Confirm MedDRA version compared to Data Mgt Plan Confirm Terminology version Include the define.xml file if present Set report parameters Study Name / Number / Dates / other text / Excel message limit Run validation Review Error report Update Issue Summary tab with Comments Refer to details tab as needed Identify / report any new bugs Consider submitting an update to terminology team If final dataset for submission to CBER then complete word doc with validation findings. CBER doc UCM
37 Questions? 37
38 Thank you! David Borbas RN, MIS Sr. Director, Data Management Jazz Pharmaceuticals, Inc P
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
More informationLex 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,
More informationImplementing 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
More informationTaming the SHREW. SDTM Heuristic Research and Evaluation Workshop
Taming the SHREW SDTM Heuristic Research and Evaluation Workshop September 13, 2013 Carlo Radovsky 2 Overview Introductions The Backstory CDISC IntraChange History of a Rule The Challenge Discuss Amongst
More informationFrom 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
More informationStudy 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
More informationDIA 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
More informationIntroduction to Define.xml
Introduction to Define.xml Bay Area CDISC Implementation Network 4 April 2008 John Brega, PharmaStat LLC Presentation Objectives 1. Introduce the concept and purpose of define.xml 2. Introduce the published
More informationTS04. Running OpenCDISC from SAS. Mark Crangle
TS04 Running OpenCDISC from SAS Mark Crangle Introduction The OpenCDISC validator is a tool used to check the compliance of datasets with CDISC standards Open-source Freely available and created by team
More informationMaterial 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
More informationUpdates on CDISC Standards Validation
Updates on CDISC Standards Validation NJ CDISC User Group September 19, 2013 Topics CDISC standards validation initiative FDA update on SEND checks OpenCDISC v1.4.1 release OpenCDISC plans 2 CDISC validation
More informationBeyond 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
More informationEdwin 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,
More informationCDASH 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.
More informationImproving 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
More informationCommon 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
More informationLex 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 * PharmaSUG 2009,
More informationCodelists Here, Versions There, Controlled Terminology Everywhere Shelley Dunn, Regulus Therapeutics, San Diego, California
ABSTRACT PharmaSUG 2016 - Paper DS16 lists Here, Versions There, Controlled Terminology Everywhere Shelley Dunn, Regulus Therapeutics, San Diego, California Programming SDTM and ADaM data sets for a single
More informationGenerating Define.xml from Pinnacle 21 Community
PharmaSUG 2018 - Paper AD-29 ABSTRACT Generating Define.xml from Pinnacle 21 Community Pinky Anandani Dutta, Inclin, Inc Define.xml is an XML document that describes the structure and contents (metadata
More informationPMDA Valida+on Rules. Preparing for your next submission to Japanese Pharmaceu6cals and Medical Devices Agency. Max Kanevsky December 10, 2015
PMDA Valida+on Rules Preparing for your next submission to Japanese Pharmaceu6cals and Medical Devices Agency Max Kanevsky December 10, 2015 Presenter Max Kanevsky Founder of OpenCDISC CEO of Pinnacle
More informationControlling OpenCDISC using R. Martin Gregory PhUSE 2012 Budapest, October 2012
Controlling OpenCDISC using R Martin Gregory PhUSE 2012 Budapest, October 2012 1 Motivation 2 Solution 3 Details 4 Conclusion Introduction OpenCDISC Validator is a project of OpenCDISC Java application
More informationAdvantages 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
More informationSDTM-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
More informationComparison 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
More informationHow to handle different versions of SDTM & DEFINE generation in a Single Study?
Paper CD15 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, Chennai,
More informationPaper 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
More informationHow 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
More informationPhUSE 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,
More informationCDASH 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
More informationDCDISC 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
More informationDataset-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
More informationSAS 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.
More informationCreating Define-XML v2 with the SAS Clinical Standards Toolkit 1.6 Lex Jansen, SAS
Creating Define-XML v2 with the SAS Clinical Standards Toolkit 1.6 Lex Jansen, SAS Agenda Introduction to the SAS Clinical Standards Toolkit (CST) Define-XML History and Background What is Define-XML?
More informationStandards 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
More informationExperience 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
More informationPharmaSUG Paper DS16
PharmaSUG 2014 - Paper DS16 OpenCDISC Validator Implementation: A Complex Multiple Stakeholder Process Terek Peterson, MBA, PRA International, USA Gareth Adams, PRA International, UK ABSTRACT The embracing
More informationSubmission-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
More informationPhUSE 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)
More informationDealing 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
More informationSandra 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
More informationDoctor's Prescription to Re-engineer Process of Pinnacle 21 Community Version Friendly ADaM Development
PharmaSUG 2018 - Paper DS-15 Doctor's Prescription to Re-engineer Process of Pinnacle 21 Community Version Friendly ADaM Development Aakar Shah, Pfizer Inc; Tracy Sherman, Ephicacy Consulting Group, Inc.
More informationAdding, editing and managing links to external documents in define.xml
SDTM-ETL 3.1 User Manual and Tutorial Author: Jozef Aerts, XML4Pharma Last update: 2015-05-25 Adding, editing and managing links to external documents in define.xml Define.xml contains the metadata of
More informationCBER 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,
More informationThe 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
More informationDefine.xml 2.0: More Functional, More Challenging
Define.xml 2.0: More Functional, More Challenging Bay Area CDISC Implementation Network 24 July 2013 John Brega, PharmaStat LLC Presentation Objectives 1. Introduce the new features in Define.xml 2.0 with
More informationRevision of Technical Conformance Guide on Electronic Study Data Submissions
Notification No. 0824001 August 24, 2016 To: Prefectural Health Department (Bureau) Director of the Advanced Review with Electronic Data Promotion Group, Pharmaceuticals and Medical Devices Agency Revision
More informationStudy Data Reviewer s Guide. FDA/PhUSE Project Summary
Study Data Reviewer s Guide FDA/PhUSE Project Summary Agenda FDA/PhUSE Collaboration Overview Study Data Reviewer s Guide (SDRG) Project Summary FDA/PhUSE Collaboration FDA Proclamation We the Masses Yearning
More informationSDTM-ETL 4.0 Preview of New Features
SDTM-ETL 4.0 Preview of New Features Author: Jozef Aerts, XML4Pharma Last update: 2018-12-01 Automated installation of new or additional SDTM/SEND templates When new versions of the SDTM-IG or SEND-IG
More informationCDISC Standards End-to-End: Enabling QbD in Data Management Sam Hume
CDISC Standards End-to-End: Enabling QbD in Data Management Sam Hume 1 Shared Health and Research Electronic Library (SHARE) A global electronic repository for developing, integrating
More informationBest Practice for Explaining Validation Results in the Study Data Reviewer s Guide
Paper DS06 Best Practice for Explaining Validation Results in the Study Data Reviewer s Guide Kristin Kelly, Pinnacle 21 LLC, Plymouth Meeting, PA, USA Michael Beers, Pinnacle 21 LLC, Plymouth Meeting,
More informationCDISC Laboratory Standards Release Notes. for. Base Model Version Schema Version Microbiology Extension Review Version
CDISC Laboratory Standards Release Notes for Base Model Version 1.0.1 Schema Version 1.0.1 Microbiology Extension Review Version Revision History Date Version Summary of Changes Primary Author 9-September-2003
More informationSAS 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.
More informationSDTM 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
More informationCDISC 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
More informationSDTM Validation Rules in XQuery
SDTM Validation Rules in XQuery FH-Prof. Dr. Jozef Aerts Univ. Appl. Sciences FH Joanneum Graz, Austria Can you understand the following validation rule (part 1)? SDTM Validation Rules in XQuery Jozef
More informationR1 Test Case that tests this Requirement Comments Manage Users User Role Management
2/19/2014 CDISC SHARE Requirements Page 1 of 23 Number Name Req ID Requirement Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage Users 2.1.1 User Role Manage
More informationIt s All About Getting the Source and Codelist Implementation Right for ADaM Define.xml v2.0
PharmaSUG 2018 - Paper SS-15 It s All About Getting the Source and Codelist Implementation Right for ADaM Define.xml v2.0 ABSTRACT Supriya Davuluri, PPD, LLC, Morrisville, NC There are some obvious challenges
More informationPlanning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database
PharmaSUG 2017 - Paper DS13 Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database ABSTRACT Cori Kramer, Ragini Hari, Keith Shusterman, Chiltern When SDTM
More informationXiangchen (Bob) Cui, Tathabbai Pakalapati, Qunming Dong Vertex Pharmaceuticals, Cambridge, MA
Building Traceability for End Points in Analysis Datasets Using SRCDOM, SRCVAR, and SRCSEQ Triplet Xiangchen (Bob) Cui, Tathabbai Pakalapati, Qunming Dong Vertex Pharmaceuticals, Cambridge, MA 2010 Vertex
More informationOut-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
More informationTips on Creating a Strategy for a CDISC Submission Rajkumar Sharma, Nektar Therapeutics, San Francisco, CA
PharmaSUG 2015 - Paper IB09 Tips on Creating a Strategy for a CDISC Submission Rajkumar Sharma, Nektar Therapeutics, San Francisco, CA ABSTRACT A submission to FDA for an NDA (New Drug Application) or
More informationCustomizing SAS Data Integration Studio to Generate CDISC Compliant SDTM 3.1 Domains
Paper AD17 Customizing SAS Data Integration Studio to Generate CDISC Compliant SDTM 3.1 Domains ABSTRACT Tatyana Kovtun, Bayer HealthCare Pharmaceuticals, Montville, NJ John Markle, Bayer HealthCare Pharmaceuticals,
More informationA CMC Reviewer s Perspective on the Quality Overall Summary. Arthur B. Shaw, Ph.D. FDA/CDER/ONDQA FDA DMF Expert June 15, 2010.
A CMC Reviewer s Perspective on the Quality Overall Summary and Module 3 Arthur B. Shaw, Ph.D. FDA/CDER/ONDQA FDA DMF Expert June 15, 2010 Disclaimer The views and opinions expressed in the following PowerPoint
More informationGlobal Checklist to QC SDTM Lab Data Murali Marneni, PPD, LLC, Morrisville, NC Sekhar Badam, PPD, LLC, Morrisville, NC
PharmaSUG 2018 Paper DS-13 Global Checklist to QC SDTM Lab Data Murali Marneni, PPD, LLC, Morrisville, NC Sekhar Badam, PPD, LLC, Morrisville, NC ABSTRACT Laboratory data is one of the primary datasets
More informationTraceability Look for the source of your analysis results
Traceability Look for the source of your analysis results Herman Ament, Cromsource CDISC UG Milan 21 October 2016 Contents Introduction, history and CDISC Traceability Examples Conclusion 2 / 24 Introduction,
More informationLegacy 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
More informationADaM Compliance Starts with ADaM Specifications
PharmaSUG 2017 - Paper DS16 ADaM Compliance Starts with ADaM Specifications Trevor Mankus, Kent Letourneau, PRA Health Sciences ABSTRACT As of December 17th, 2016, the FDA and PMDA require that all new
More informationADaM Reviewer s Guide Interpretation and Implementation
Paper CD13 ADaM Reviewer s Guide Interpretation and Implementation Steve Griffiths, GlaxoSmithKline, Stockley Park, UK ABSTRACT Throughout the course of a study, teams will make a lot of decisions about
More informationAn 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
More informationPharmaSUG Paper PO22
PharmaSUG 2015 - Paper PO22 Challenges in Developing ADSL with Baseline Data Hongyu Liu, Vertex Pharmaceuticals Incorporated, Boston, MA Hang Pang, Vertex Pharmaceuticals Incorporated, Boston, MA ABSTRACT
More informationWhat is high quality study metadata?
What is high quality study metadata? Sergiy Sirichenko PhUSE Annual Conference Barcelona, 2016 What is study metadata? Trial Design domains Reviewer s Guides acrf Define.xml Conclusion Topics What is study
More informationSDTM-ETL 3.1 User Manual and Tutorial
SDTM-ETL 3.1 User Manual and Tutorial Author: Jozef Aerts, XML4Pharma Last update: 2014-07-19 Creating mappings for the AE domain Now that we have created (and executed) mappings for several domains, let
More informationWhy organizations need MDR system to manage clinical metadata?
PharmaSUG 2018 - Paper SS-17 Why organizations need MDR system to manage clinical metadata? Abhinav Jain, Ephicacy Consulting Group Inc. ABSTRACT In the last decade, CDISC standards undoubtedly have transformed
More informationBay Area CDISC Network: PhUSE Working Group for Inspection Site Selection Data Standards
Bay Area CDISC Network: PhUSE Working Group for Inspection Site Selection Data Standards Patricia Gerend Genentech, Inc., A Member of the Roche Group 30 April 2015 Agenda Page 2 Introduction to PhUSE Working
More informationStreamline SDTM Development and QC
Paper SI09 Streamline SDTM Development and QC Stephen Gormley, Amgen, United Kingdom ABSTRACT Amgen s Global Statistical Programming ( GSP ) function have one centralised team (The CDISC Consultancy and
More informationSCDM 2017 ANNUAL CONFERENCE. September I Orlando
SCDM 2017 ANNUAL CONFERENCE September 24-27 I Orlando CDASH 2.0 What s New and How Does It Impact Me? Panel Discussion Moderator: Dawn M. Kaminski Director, Clinical Data Strategies Accenture Before We
More informationStudy Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata
Paper SD02 Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata Dr. Philippe Verplancke, XClinical GmbH, Munich, Germany ABSTRACT define.xml is often created at the end of
More informationAquila's Lunch And Learn CDISC The FDA Data Standard. Disclosure Note 1/17/2014. Host: Josh Boutwell, MBA, RAC CEO Aquila Solutions, LLC
Aquila's Lunch And Learn CDISC The FDA Data Standard Host: Josh Boutwell, MBA, RAC CEO Aquila Solutions, LLC Disclosure Note This free training session will be placed on Aquila s website after the session
More informationCustomer 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
More informationBusiness & Decision Life Sciences
Business & Decision Life Sciences Moving to Define.xml v2.0.0 for CDISC FSUG Anne-Sophie Bekx / 22 May 2014 Introduction Differences Impact Introduction History of Define.xml February 2005: CRT-DDS Final
More informationPharmaceuticals, Health Care, and Life Sciences. An Approach to CDISC SDTM Implementation for Clinical Trials Data
An Approach to CDISC SDTM Implementation for Clinical Trials Data William T. Chen, Merck Research Laboratories, Rahway, NJ Margaret M. Coughlin, Merck Research Laboratories, Rahway, NJ ABSTRACT The Clinical
More informationHelping The Define.xml User
Paper TT01 Helping The Define.xml User Dave Iberson-Hurst, Assero Limited, Teignmouth, United Kingdom ABSTRACT The FDA often comment at industry gatherings on the quality of define.xml files received as
More informationPharmaSUG Paper AD03
PharmaSUG 2017 - Paper AD03 Three Issues and Corresponding Work-Around Solution for Generating Define.xml 2.0 Using Pinnacle 21 Enterprise Jeff Xia, Merck & Co., Inc., Rahway, NJ, USA Lugang (Larry) Xie,
More informationSTUDY DATA TECHNICAL CONFORMANCE GUIDE
STUDY DATA TECHNICAL CONFORMANCE GUIDE Technical Specifications Document This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions
More informationThe 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
More informationSAS Application to Automate a Comprehensive Review of DEFINE and All of its Components
PharmaSUG 2017 - Paper AD19 SAS Application to Automate a Comprehensive Review of DEFINE and All of its Components Walter Hufford, Vincent Guo, and Mijun Hu, Novartis Pharmaceuticals Corporation ABSTRACT
More informationOptimization 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
More informationADaM and traceability: Chiesi experience
ADaM and traceability: Chiesi experience BIAS Seminar «Data handling and reporting in clinical trials with SAS» Glauco Cappellini 22-Feb-2013 Agenda Chiesi Model for Biometrics Regulatory Background ADaM:
More informationAutomate Clinical Trial Data Issue Checking and Tracking
PharmaSUG 2018 - Paper AD-31 ABSTRACT Automate Clinical Trial Data Issue Checking and Tracking Dale LeSueur and Krishna Avula, Regeneron Pharmaceuticals Inc. Well organized and properly cleaned data are
More informationHarmonizing CDISC Data Standards across Companies: A Practical Overview with Examples
PharmaSUG 2017 - Paper DS06 Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples Keith Shusterman, Chiltern; Prathima Surabhi, AstraZeneca; Binoy Varghese, Medimmune ABSTRACT
More informationStandards Driven Innovation
Standards Driven Innovation PhUSE Annual Conference 2014 Frederik Malfait IMOS Consulting GmbH, Hoffmann-La Roche AG Managing Standards 2 Data Standards Value Proposition Standards are increasingly mandated
More informationNow 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,
More informationSAS, XML, and CDISC. Anthony T Friebel XML Development Manager, SAS XML Libname Engine Architect SAS Institute Inc.
SAS, XML, and CDISC Anthony T Friebel XML Development Manager, SAS XML Libname Engine Architect SAS Institute Inc. SAS is a registered trademark or trademark of SAS Institute Inc. in the USA and other
More informationPower Data Explorer (PDE) - Data Exploration in an All-In-One Dynamic Report Using SAS & EXCEL
Power Data Explorer (PDE) - Data Exploration in an All-In-One Dynamic Report Using SAS & EXCEL ABSTRACT Harry Chen, Qian Zhao, Janssen R&D China Lisa Lyons, Janssen R&D US Getting to know your data is
More informationAUTOMATED 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
More information%check_codelist: A SAS macro to check SDTM domains against controlled terminology
Paper CS02 %check_codelist: A SAS macro to check SDTM domains against controlled terminology Guido Wendland, UCB Biosciences GmbH, Monheim, Germany ABSTRACT The SAS macro %check_codelist allows programmers
More informationStandards Implementation: It Should be Simple Right? Thursday January 18, 2018
Standards Implementation: It Should be Simple Right? Thursday January 18, 2018 Upcoming MassBio Forums January 18, 2018; 4-6pm: TODAY!! 2018 JP Morgan Recap: An Insiders View BD/Fin & EU February 1, 2018;
More informationConverting 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
More informationCreating 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
More informationMapping and Terminology. English Speaking CDISC User Group Meeting on 13-Mar-08
Mapping and Terminology English Speaking CDISC User Group Meeting on 13-Mar-08 Statement of the Problem GSK has a large drug portfolio, therefore there are many drug project teams GSK has standards 8,200
More information