Traceability Look for the source of your analysis results
|
|
- Phebe Parks
- 5 years ago
- Views:
Transcription
1 Traceability Look for the source of your analysis results Herman Ament, Cromsource CDISC UG Milan 21 October 2016
2 Contents Introduction, history and CDISC Traceability Examples Conclusion 2 / 24
3 Introduction, History In the past submission approvals consisted of a truck full of paper to demonstrate the efficacy and safety of a (new) drug. Around 2000, instead of submissions on paper, submission via digital data carriers became more and more the standard. Problem: each company had their own standard. FDA spent 85% of their time to understand the data. Only 15% time left for doing the analysis. Feb 2000 Clinical Data Interchange Standards Consortium (CDISC) was formed as an Independent, non-profit organization. February 2005, release version 1.0 of Define.xml. 3 / 24
4 Introduction, History cont d Around 2000 stagnation of New Drug Applications (less Block Busters). 2004, FDA Critical Path Initiative (CPI). To drive innovation in the scientific processes within the Pharma Industry. FDA: Allegations to overlook safety concern and to give approval to unsafe drugs (example: Vioxx 2005). The last 10 years, more and more information has to be provided to the authorities, in order to demonstrate the efficacy and safety and to show transparency of the data submitted. 4 / 24
5 CDISC CDISC is the source for the standard for clinical data within the Pharmaceutical Industry. Standardisation of machine readable data SEND, CDASH, SDTM, ADaM Standardisation of human readable data (define.xml). Standardisation of Controlled Terminology. Many Implementation Guides (IG), including Analysis Data Reviewers Guide (ADRG) Among this all, the principles of GCP: Traceability and Transparency. ICH: strongly involved SEND=Standard for Exchange of Nonclinical Data, CDASH=Clinical Data Acquisition Standards Harmonization, SDTM=Study Data Tabulation Model, ADaM=Analysis Data Model 5 / 24
6 6 / 24
7 Traceability, ADaM IG 1.1, Definition IG=Implementation Guide Traceability The property that enables the understanding of the data s lineage and/or the relationship between an (data) element and its predecessor(s). Traceability facilitates transparency, which is an essential component in building confidence in a result or conclusion. Ultimately, traceability in ADaM permits the understanding of the relationship between the analysis results, the ADaM datasets, the SDTM datasets, and the data collection instrument. Traceability is built by clearly establishing the path between an (data) element and its immediate predecessor. 7 / 24
8 Traceability, ADAM IG cont d The full path is traced by going from one element to its predecessors, then on to their predecessors, and so on, back to the SDTM datasets, and ultimately to the data collection instrument. IG: Section 2.2: To assist review, ADaM datasets and metadata must clearly communicate how the ADaM datasets were created. The verification of derivations in an ADaM dataset requires having at hand the input data used to create the ADaM dataset. A CDISC-conformant submission includes both SDTM and ADaM datasets; therefore, it follows that the relationship between SDTM and ADaM must be clear. This requirement highlights the importance of traceability between the analyzed data (ADaM) and its input data (SDTM). 8 / 24
9 Traceability, 2 levels, Metadata level Metadata traceability facilitates the understanding of the relationship of the analysis variable to its source dataset(s) and variable(s) and is required for ADaM compliance. This traceability is established by describing (via metadata) the algorithm used or steps taken to derive or populate an analysis variable from its immediate predecessor. Metadata traceability is also used to establish the relationship between an analysis result and ADaM dataset(s). 9 / 24
10 Traceability, BMI Metadata level example Collected on ecrf: Height and Weight Specified in SAP: Demographic and Other Baseline Characteristics In ADaM Define.xml, relation to SDTM and algorithm 10 / 24
11 Traceability, 2 levels, Datapoint level Datapoint traceability points directly to the specific predecessor record(s) and should be implemented if practical and feasible. This level of traceability can be very helpful when trying to trace a complex data manipulation path. This traceability is established by providing clear links in the data (e.g., use of SEQ variable) to the specific data values used as input for an analysis value. The BDS and OCCDS structures were designed to enable datapoint traceability back to predecessor data. BDS=Basic Data Structure OCCDS=ADaM Occurrence Data Structure 11 / 24
12 Traceability, 2 levels, Datapoint level Typical examples of variables from SDTM domains that help in establishing traceability in ADaM are Sequence Variables (--SEQ), Sponsor Defined Identifiers (--SPID), Group Identifiers (--GRPID), Timing Variables (VISIT, VISITNUM, EPOCH, --DTC, DY) etc. Examples of additional variables that can be added in ADaM to achieve some level of traceability are Analysis Flag variables (ANLzzFL) - to indicate the records that were chosen for analysis among the multiple visits that fall within the same analysis time point windows, Criterion variables CRITy - text description defining the conditions necessary to satisfy the presence of the criterion and CRITyFL - character indicator of whether the criterion described in CRITy was met. If additional records were added to analysis datasets for analyses purposes, to establish traceability, BDS allows the usage of variable DTYPE DTYPE (Derivation Type) which precisely populates the derivation algorithm used to derive an analysis value. 12 / 24
13 ADRG, Analysis Data Reviewers Guide Purpose The Analysis Data Reviewer s Guide (ADRG) provides FDA Reviewers with additional context for analysis datasets (AD) received as part of a regulatory submission. The ADRG is intended to describe analysis data submitted for an individual study in the Module 5 clinical section of the ectd. The ADRG purposefully duplicates limited information found in other submission documentation (e.g., the protocol, statistical analysis plan, clinical study report, define.xml) in order to provide FDA Reviewers with a single point of orientation to the analysis datasets. The submission of a reviewer guide does not obviate the requirement to submit a complete and informative define.xml document to accompany the analysis datasets. 13 / 24
14 ADRG, Analysis Data Reviewers Guide ADRG, submission of the results Program statements 14 / 24
15 Traceability flowchart Data Management SDTM ADAM 15 / 24
16 Traceability, Results Example Primary objective in the PROTOCOL. To evaluate the superiority of XXX versus YYY in terms of FEV1 AUC0-12h normalised by time on Day 42 Primary efficacy variable in SAP FEV1 (L) (both in terms of absolute values and change from baseline) will be summarised by summary statistics (including the 95% CI of the mean) at Day 1 and 42 and all scheduled time points by treatment for the ITT and PP population. The primary efficacy endpoint (FEV1 AUC0-12h normalised by time on Day 42) will be summarised using summary statistics (including the 95% CI of the mean) and will be displayed by treatment for the ITT and PP population. Parameter, FEV1 AUC0-12h normalised by time Time point: Day / 24
17 Traceability, Results Example Parameter, FEV1 AUC0-12h normalised by time Timepoint: Day 42. Source reference to appropriate listing. 17 / 24
18 Traceability, Results Example 18 / 24
19 Traceability, Data Example SAP Definition of FEV1 AUC0-12h normalised by time 19 / 24
20 Traceability, SDTM 20 / 24
21 Traceability, ADaM AVAL/AVALC, source result where XLTESTC= FEV1 Criterion flag is used to specify whether the observation is used in the analyses 21 / 24
22 Traceability, SDTM + ADaM SDTM data, source ADAM data, PARAMTYP and CRIT1FL 22 / 24
23 Conclusion Building in traceability is challenging job. Starts at Protocol and ends at submission. Traceability should be in the documents and in the data. CDISC enables to build in traceability with variables like PARAMTYPE, DTYPE, --SEQ and many other. Traceability is a joined effort across departments project management, data management, biostatistics, medical writing Resources. CDISC organisation. Become a member! Phusewiki Proceedings SAS Global Forum, SUGI, PharmaSUG, NESUG, SESUG, PhUSE, WUSS, MWSUG, PNWSUG and SCSUG / 24
24 THANK YOU! Herman Ament Senior SAS Programmer Ph +31 (0) ext / 24
25 Traceability, phusewiki.org 25 / 24
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
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 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 informationAn Efficient Solution to Efficacy ADaM Design and Implementation
PharmaSUG 2017 - Paper AD05 An Efficient Solution to Efficacy ADaM Design and Implementation Chengxin Li, Pfizer Consumer Healthcare, Madison, NJ, USA Zhongwei Zhou, Pfizer Consumer Healthcare, Madison,
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 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 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 informationAnalysis Data Model Implementation Guide Version 1.1 (Draft) Prepared by the CDISC Analysis Data Model Team
Analysis Data Model Implementation Guide Version 1.1 (Draft) Prepared by the CDISC Analysis Data Model Team Notes to Readers This Implementation Guide is version 1.1 and corresponds to Version 2.1 of the
More informationThe 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
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 informationProgramming 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.,
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 informationWhat is the ADAM OTHER Class of Datasets, and When Should it be Used? John Troxell, Data Standards Consulting
Accenture Accelerated R&D Services Rethink Reshape Restructure for better patient outcomes What is the ADAM OTHER Class of Datasets, and When Should it be Used? John Troxell, Data Standards Consulting
More informationThe Implementation of Display Auto-Generation with Analysis Results Metadata Driven Method
PharmaSUG 2015 - Paper AD01 The Implementation of Display Auto-Generation with Analysis Results Metadata Driven Method Chengxin Li, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA ABSTRACT
More informationUse of Traceability Chains in Study Data and Metadata for Regulatory Electronic Submission
PharmaSUG 2017 - Paper SS03 Use of Traceability Chains in Study Data and Metadata for Regulatory Electronic Submission ABSTRACT Tianshu Li, Celldex Therapeutics, Hampton, NJ Traceability is one of the
More informationApplying ADaM Principles in Developing a Response Analysis Dataset
PharmaSUG2010 Paper CD03 Applying ADaM Principles in Developing a Response Analysis Dataset Mei Dey, Merck & Co., Inc Lisa Pyle, Merck & Co., Inc ABSTRACT The Clinical Data Interchange Standards Consortium
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 informationPharmaSUG 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
More informationAutomate Analysis Results Metadata in the Define-XML v2.0. Hong Qi, Majdoub Haloui, Larry Wu, Gregory T Golm Merck & Co., Inc.
Automate Analysis Results Metadata in the Define-XML v2.0 Hong Qi, Majdoub Haloui, Larry Wu, Gregory T Golm Merck & Co., Inc., USA 1 Topics Introduction Analysis Results Metadata (ARM) Version 1.0 o o
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 informationLeveraging 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.,
More informationIntroduction to ADaM standards
Introduction to ADaM standards Elke Sennewald, Director Biostatistics EU/AP, 06 March 2009 1 Outline ADaM Version 2.0 / 2.1 General Considerations ADaM draft Version 2.1 ADaMIG draft Version 1.0 ADaM Variables
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 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 informationADaM for Medical Devices: Extending the Current ADaM Structures
PharmaSUG 2018 - Paper MD-02 ADaM for Medical s: Extending the Current ADaM Structures Sandra Minjoe, PRA Health Sciences; Julia Yang, Medtronic PLC; Priya Gopal, TESARO, Inc. ABSTRACT The current ADaM
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 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 informationStudy 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 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 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 informationPharmaSUG 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
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 informationCreating an ADaM Data Set for Correlation Analyses
PharmaSUG 2018 - Paper DS-17 ABSTRACT Creating an ADaM Data Set for Correlation Analyses Chad Melson, Experis Clinical, Cincinnati, OH The purpose of a correlation analysis is to evaluate relationships
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 informationHow 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
More informationDeriving Rows in CDISC ADaM BDS Datasets
ABSTRACT PharmaSUG 2017 Paper DS22 Deriving Rows in CDISC ADaM BDS Datasets Sandra Minjoe, Accenture Accelerated R&D Services The ADaM Basic Data Structure (BDS) can be used for many analysis needs, including
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 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 informationReporting & 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
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 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 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 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 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 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 informationHands-On ADaM ADAE Development Sandra Minjoe, Accenture Life Sciences, Wayne, Pennsylvania
PharmaSUG 2013 - Paper HT03 Hands-On ADaM ADAE Development Sandra Minjoe, Accenture Life Sciences, Wayne, Pennsylvania ABSTRACT The Analysis Data Model (ADaM) Data Structure for Adverse Event Analysis
More informationImplementing CDISC at Boehringer Ingelheim
Paper CD03 Implementing CDISC at Boehringer Ingelheim Michael Knoessl, Boehringer Ingelheim, Ingelheim, Germany Peter Leister, IBM, Hamburg, Germany ABSTRACT The Study Data Tabulation Model (SDTM), as
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 informationStudy Data Technical Conformance Guide (TCG)
Study Data Technical Conformance Guide (TCG) Webinar Series 2017 Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) The TCG TCG provides recommendations
More informationPharmaSUG DS05
PharmaSUG 2013 - DS05 Building Traceability for End Points in Datasets Using SRCDOM, SRCVAR, and SRCSEQ Triplet Xiangchen Cui, Vertex Pharmaceuticals Incorporated Tathabbai Pakalapati, Cytel Inc. Qunming
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 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 informationADaM Implementation Guide Prepared by the CDISC ADaM Team
1 2 3 ADaM Implementation Guide Prepared by the CDISC ADaM Team 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Revision History Notes to Readers Date Version Summary of Changes May 30, 2008 1.0 Draft
More informationFrom SDTM to displays, through ADaM & Analyses Results Metadata, a flight on board METADATA Airlines
From SDTM to displays, through ADaM & Analyses Results Metadata, a flight on board METADATA Airlines Omar SEFIANI - Stéphane BOUGET, Boehringer Ingelheim DH13, PhUSE Barcelona 2016, October, 12 th Outline
More informationesubmission - Are you really Compliant?
ABSTRACT PharmaSUG 2018 - Paper SS21 esubmission - Are you really Compliant? Majdoub Haloui, Merck & Co., Inc., Upper Gwynedd, PA, USA Suhas R. Sanjee, Merck & Co., Inc., Upper Gwynedd, PA, USA Pinnacle
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 informationPharmaSUG 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
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 informationHands-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
More informationClinical Metadata Metadata management with a CDISC mindset
Paper SI02 Clinical Metadata Metadata management with a CDISC mindset Andrew Ndikom, Clinical Metadata, London, United Kingdom Liang Wang, Clinical Metadata, London, United Kingdom ABSTRACT Metadata is
More informationManaging 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,
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 informationAvoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation
ABSTRACT Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation Richann Watson, Experis, Batavia, OH Karl Miller, inventiv Health, Lincoln, NE The ADaM Implementation Guide was created
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 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 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 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 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 informationOptimization of the traceability when applying an ADaM Parallel Conversion Method
Paper SI04 Optimization of the traceability when applying an ADaM Parallel Conversion Method DEBRUS Roxane, Business & Decision Life Sciences, Brussels, Belgium ABSTRACT One of the methods to create CDISC
More informationAutomated 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
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 informationPaper DS07 PhUSE 2017 CDISC Transport Standards - A Glance. Giri Balasubramanian, PRA Health Sciences Edwin Ponraj Thangarajan, PRA Health Sciences
Paper DS07 PhUSE 2017 CDISC Transport Standards - A Glance Giri Balasubramanian, PRA Health Sciences Edwin Ponraj Thangarajan, PRA Health Sciences Agenda Paper Abstract CDISC Standards Types Why Transport
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 informationFrom SAP to BDS: The Nuts and Bolts Nancy Brucken, i3 Statprobe, Ann Arbor, MI Paul Slagle, United BioSource Corp., Ann Arbor, MI
PharmaSUG2011 - Paper HW05 From SAP to BDS: The Nuts and Bolts Nancy Brucken, i3 Statprobe, Ann Arbor, MI Paul Slagle, United BioSource Corp., Ann Arbor, MI ABSTRACT You've just read through the protocol,
More informationTraceability in the ADaM Standard Ed Lombardi, SynteractHCR, Inc., Carlsbad, CA
ABSTRACT PharmaSUG 2013 - Paper PO13 Traceability in the ADaM Standard Ed Lombardi, SynteractHCR, Inc., Carlsbad, CA Traceability is one of the fundamentals of the ADaM Standard. However, there is not
More informationRiepilogo 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
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 informationOpenCDISC Validator 1.4 What s New?
OpenCDISC Validator 1.4 What s New? Bay Area CDISC Implementation Network 23 May 2013 David Borbas Sr Director, Data Management Jazz Pharmaceuticals, Inc. Disclaimers The opinions expressed in this presentation
More informationCost-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
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 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 informationStandards for the Management of Clinical Trial Data, why are they needed, what is needed?
Paper PP11 Standards for the Management of Clinical Trial Data, why are they needed, what is needed? Isabelle ABOUSAHL-CHAUNU, Ipsen Innovation, Les Ulis, France ABSTRACT Ipsen has made the choice to replace
More informationStandardising 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
More informationPharmaSUG Paper DS24
PharmaSUG 2017 - Paper DS24 ADQRS: Basic Principles for Building Questionnaire, Rating and Scale Datasets Nancy Brucken, inventiv Health, Ann Arbor, MI Karin LaPann, Shire, Lexington, MA ABSTRACT Questionnaires,
More informationFDA XML Data Format Requirements Specification
FDA XML Data Format Barry Brown, Product Integration Manager, Mortara Instrument Mark Kohls, Engineering Director, GE Medical Systems-Information Technologies Norman Stockbridge, M.D., Ph. D., Medical
More informationCDISC Standards and the Semantic Web
CDISC Standards and the Semantic Web Dave Iberson-Hurst 12 th October 2015 PhUSE Annual Conference, Vienna 1 Abstract With the arrival of the FDA guidance on electronic submissions, CDISC SHARE and the
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 informationNCI/CDISC or User Specified CT
NCI/CDISC or User Specified CT Q: When to specify CT? CT should be provided for every variable with a finite set of valid values (e.g., the variable AESEV in ADAE can have the values MILD, MODERATE or
More informationA 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
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 informationPharmaSUG 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
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 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 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 informationInterpreting CDISC ADaM IG through Users Interpretation
Paper CD01 Interpreting CDISC ADaM IG through Users Interpretation Angelo Tinazzi, Cytel Inc., Geneva, Switzerland ABSTRACT It is now almost three years CDISC ADaM is an official standard the pharmaceutical
More informationPooling Clinical Data: Key points and Pitfalls. October 16, 2012 Phuse 2012 conference, Budapest Florence Buchheit
Pooling Clinical Data: Key points and Pitfalls October 16, 2012 Phuse 2012 conference, Budapest Florence Buchheit Introduction Are there any pre-defined rules to pool clinical data? Are there any pre-defined
More informationManaging 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
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 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 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 information