CDISC based eSubmission Key Points of the CDISC SDTM/ADaM Pilot

Slides:



Advertisements
Similar presentations
Monika Kawohl Principal Statistical Programmer Accovion
Advertisements

Dimitri Kutsenko (Entimo AG)
Principal Statistical Programmer Accovion GmbH, Marburg, Germany
CDISC Open Source and low-cost Solutions
ADaM Implementation Guide: It’s Almost Here. Are You Ready?
INSTITUTE FOR CYBER SECURITY April Access Control and Semantic Web Technologies Ravi Sandhu Executive Director and Endowed Chair Institute for Cyber.
Resource Description And Access: The Practical Impact of RDA Patricia Longo OLA Conference February 2, 2008.
GL10 – December 8-9, Grey literature in French digital repositories: a survey J. Schöpfel (University of Lille 3) C. Stock (INIST-CNRS)
FDA/Industry Statistics Workshop - 29 September 2006
Sep 3, 2008NVOSS Mobile VO Mike Fitzpatrick NOAO.
Masterclass Introduction to hands-on Exercise Aim of the exercise Find out what happens in proton-proton collisions at the LHC as seen by the ATLAS.
10/04/20081 TWG of ESF Committee 10 April 2008 Franck Sébert Head of unit DG EMPL/I/1 Relations with Control Authorities Action plan to strengthen the.
Core Competencies Training for Supervisors
Experience and process for collaborating with an outsource company to create the define file. Ganesh Sankaran TAKE Solutions.
Copyright © 2012 Quintiles Define.XML A CASE study describing how to produce Define.XML from within SAS Dianne Weatherall Sep 2012.
UK Higher Education library statistics The role of SCONUL.
Managing and Analyzing Clinical Data
The Importance of CDASH
Quick tour of CDISC’s ADaM standard
© 2008 Octagon Research Solutions, Inc. All Rights Reserved. 1 PhUSE 2010 Berlin * Accessing the metadata from the define.xml using XSLT transformations.
Copyright © 2010, SAS Institute Inc. All rights reserved. Define.xml - Tips and Techniques for Creating CRT - DDS Julie Maddox Mark Lambrecht SAS Institute.
Monika Kawohl Statistical Programming Accovion GmbH Tutorial: define.xml.
23 August 2015Michael Knoessl1 PhUSE 2008 Manchester / Michael Knoessl Implementing CDISC at Boehringer Ingelheim.
JumpStart the Regulatory Review: Applying the Right Tools at the Right Time to the Right Audience Lilliam Rosario, Ph.D. Director Office of Computational.
CBER CDISC Test Submission Dieter Boß CSL Behring, Marburg 20-Mar-2012.
© 2011 Octagon Research Solutions, Inc. All Rights Reserved. The contents of this document are confidential and proprietary to Octagon Research Solutions,
PhUSE SDE, 28-May A SAS based Solution for define.xml Monika Kawohl Statistical Programming Accovion.
Implementation of a harmonized, report-friendly SDTM and ADaM Data Flow General by Marie-Rose Peltier Experience by Marie Fournier Groupe Utilisateurs.
Vertex and CDISC / MBC / 12March Vertex and CDISC Accomplishments and Strategy 12 March 2008 Lynn Anderson Associate Director Statistical Programming/Biometrics.
Antje Rossmanith, Roche 14th German CDISC User Group, 25-Sep-2012
1CDISC 2002 RCRIM – Standard Domains Agenda NCI Presentation Standard Domains Working Group Goals Introduction to FDA Information Model (FIM) Discussion:
Overview and feed-back from CDISC European Interchange 2008 (From April 21 st to 25 th, COPENHAGEN) Groupe des Utilisateurs Francophones de CDISC Bagneux.
Confidential - Property of Navitas Accelerate define.xml using defineReady - Saravanan June 17, 2015.
Second Annual Japan CDISC Group (JCG) Meeting 28 January 2004 Julie Evans Director, Technical Services.
© Copyright 2008 ADaM Validation and Integrity Checks Wednesday 12 th October 2011 Louise Cross ICON Clinical Research, Marlow, UK.
SDTM Validation Delaware Valley CDISC user network Ketan Durve Johnson and Johnson Pharmaceutical Reasearch and Development May 11 th 2009.
SAS Programmer in Teva Pharmaceuticals Job Description The basic responsibilities are to provide SAS programming support in deriving analysis datasets,
Implementation of CDISC Standards at Nycomed PhUSE, Basel (19-21 October 2009) Nycomed GmbH, Dr. B Traub CDISC Implementation at Nycomed.
Dave Iberson-Hurst CDISC VP Technical Strategy
Kopenhagen, 22 April 2008 German CDISC User Group.
Research based, people driven CDISC ADaM Datasets - from SDTM to submission CDISC Experience Exchange and ADaM Workshop 15 Dec 2008 Zoë Williams, LEO Pharma.
WG4: Standards Implementation Issues with CDISC Data Models Data Guide Subteam Summary of Review of Proposed Templates and Next Steps July 23, 2012.
Research Study Data Standards Standards for research study data for submission to regulatory authorities Standard development divided into three parts:
Copyright © 2015, SAS Institute Inc. All rights reserved. Future Drug Applications with No Tables, Listings and Graphs? PhUSE Annual Conference 2015, Vienna.
1 Much ADaM about Nothing – a PROC Away in a Day EndriPhUSE Conference Rowland HaleBrighton (UK), 9th - 12th October 2011.
German Speaking CDISC UG, 22-Sep CDER Common Data Standards Issues Document Motivation CDISC submissions received varied more than expected Contents.
April ADaM define.xml - Metadata Design Analysis Results Metadata List of key analyses (as defined in change order) Analysis Results Metadata per.
How Good is Your SDTM Data? Perspectives from JumpStart Mary Doi, M.D., M.S. Office of Computational Science Office of Translational Sciences Center for.
Generation of real-time SDTM datasets and metadata through a generic SDTM converter mechanism CDISC (CDASH/SDTM) integration into OC/RDC Peter Van Reusel.
Basel, September 2, 2008 Work Stream Summary define.xml/eSubmissions.
Dave Iberson-Hurst CDISC VP Technical Strategy
Monika Kawohl Statistical Programming Accovion GmbH
define.xml/eSubmissions
Experience and process for collaborating with an outsource company to create the define file. Ganesh Sankaran TAKE Solutions.
Accelerate define.xml using defineReady - Saravanan June 17, 2015.
Secondary Uses Primary Use EHR and other Auhortities Clinical Trial
SDTM Work Stream Basel, September 2, 2008.
Monika Kawohl Statistical Programming Accovion GmbH
MAKE SDTM EASIER START WITH CDASH !
Traceability between SDTM and ADaM converted analysis datasets
Quality Control of SDTM Domain Mappings from Electronic Case Report Forms Noga Meiry Lewin, MS Senior SAS Programmer The Emmes Corporation Target: 38th.
Monika Kawohl Statistical Programming Accovion GmbH
To change this title, go to Notes Master
Monika Kawohl Statistical Programming Accovion GmbH
Generating Define.xml at Kendle using DefinedocTM
An FDA Statistician’s Perspective on Standardized Data Sets
Generating Define.xml at Kendle using DefinedocTM
SDTM Work Stream Basel, September 2, 2008.
Data Submissions Douglas Warfield, Ph.D. Technical Lead, eData Team
The role of metadata in census data dissemination
Presentation transcript:

CDISC based eSubmission Key Points of the CDISC SDTM/ADaM Pilot Monika Kawohl Senior Statistical Programmer Accovion GmbH, Marburg, Germany

Outline Coverage & Aim Process CDISC Model Specifics SDTM ADaM Define.xml FDA Reviewers‘ Feedback Summary and Conclusions CDISC German UG Meeting 02-Sep-2008

Coverage Legacy data conversion of 1 study to SDTM SDTM domains (SAS V5 XPT format) Annotated CRF ADaM datasets created from SDTM Analysis Results based on ADaM datasets All tied together via Metadata in define.xml eCTD structure but PDF TOC files CDISC German UG Meeting 02-Sep-2008

Coverage - Pilot Submission Structure eCTD/eNDA hybrid: PDF TOCs, eCTD folders Source: Project Report – CDISC SDTM/ADaM Pilot CDISC German UG Meeting 02-Sep-2008

Aim Verify interoperability of CDISC standards Obtain FDA reviewers‘ feedback Provide implementation example Gap analysis of single CDISC Standards But ... Not intended as guidance regarding Contents Process applied CDISC German UG Meeting 02-Sep-2008

Process CDISC German UG Meeting 02-Sep-2008 Source: Webcast – Results and Lessons from the CDISC SDTM/ADaM Pilot Project CDISC German UG Meeting 02-Sep-2008

Process – Legacy Data Conversion Source-centric mapping specification QC of specifications before programming started Mapping via ETL Tool CDISC German UG Meeting 02-Sep-2008

Process – SDTM/ADaM/define.xml SDTM “without“ derived => ADaM => SDTM some derived Facilitates usage of derived data in SDTM review tools Lineage issue Explorative use - final decision pending Definition of metadata at specification level Prescriptive use of metadata reduces consistency issues (Suite of SAS macros used available to CDISC members) Concise computational algorithm descriptions No programs were submitted CDISC German UG Meeting 02-Sep-2008

Process – Prescriptive Use of Metadata CDISC German UG Meeting 02-Sep-2008

Process – Quality Control (QC) QC of specifications QC of programming/mapping against specifications Option: independent re-programming QC of Analysis Results against SAP QC of define.xml Verifying links and contents Verifying of technical requirements via tools Consistency via automated process based on metadata CDISC German UG Meeting 02-Sep-2008

CDISC Model Specifics CDISC SDTM IG V3.1.1 CDISC SDTM V1.1 CDISC ADaM CDISC ADaM IG was not yet available (in preparation) CDISC CRT-DDS (define.xml) V1.0 CDISC ODM V1.3 for define.xml define.xml V1.0 standard based on ODM V1.2 Custom stylesheet Schema extension for ADaM part CDISC German UG Meeting 02-Sep-2008

CDISC SDTM Specifics SDTM “without derived“ Includes SDTM required derived variables, e.g., USUBJID, --BLFL, (--DY) SDTM “with some derived“ Purpose: viewing derived data in standard domain structures Includes data derived in the ADaM creation step Population Flags (SUPPDM) AE Treatment Emergent Flag and MedDRA variables (SUPPAE) Endpoint Flag and Result Divided by UL of Normal Range (SUPPLB) Total Score as sum of single scores (New record in QS) ADaM => SDTM ensures consistency of derivation results CDISC German UG Meeting 02-Sep-2008

CDISC ADaM Specifics Important since SDTM datasets not analysis-ready ADSL concept of ADaM V2.0 ADSL very helpful for all reviewers Baseline Characteristics Treatment Variables Population Flags Patient Completion Status Start and End of Study Drug, Date Patient was Last Observed All analysis datasets instead of datasets for key analyses At least Analysis Metadata could be limited to key results CDISC German UG Meeting 02-Sep-2008

CDISC ADaM Specifics (Continued) Tracebility and transparency of analysis datasets Clear lineage from CRF to analysis Clear, unambigous metadata (computation methods) Include all CRF data + derived data Appropriate data selection via flags Facilitate reproduction of analysis results Allow for sensitivity analysis, test of robustness Sponsor-specific standards, e.g. variable names, PARAMs NOW available: Draft ADaM IG CDISC German UG Meeting 02-Sep-2008

CDISC ADaM Concept Sample Selected variables from adqsadas.xpt Communication of analysis performed SDTM reference ADSL variables CDISC German UG Meeting 02-Sep-2008

CDISC define.xml Specifics SDTM and ADaM metadata included in 1 define.xml file Facilitate links between SDTM and ADaM and vice versa Define.xml included in tabulations and analysis eCTD folder Navigation improved (define.pdf comparable) Framed version solves back button issue (IE specific) CDISC German UG Meeting 02-Sep-2008

CDISC define.xml Specifics (Continued) Valuable sample for Analysis Metadata List of Analysis Results Standardized results description incl. links to Analysis output, underlying dataset, specifications (e.g. SAP) Layout not 100% consistent with new Draft ADaM documents CDISC German UG Meeting 02-Sep-2008

Define.xml – Analysis Metadata Sample Link to Analysis Metadata (s.b.) Link to CSR Table Link to Variable Metadata of ADSL Link to SAP CDISC German UG Meeting 02-Sep-2008

CDISC define.xml Specifics (continued) Deviations from Draft Metadata Submission Guidelines All derivations described via computation methods Separate column Comment column reserved for ADaM links to source datasets No Variable Value Level Metadata Limited to Controlled Terminology for test codes and names Controlled Terminology representation subdivided in Code Lists (Code and Decode) Discrete Value Listings Printing Issue CDISC German UG Meeting 02-Sep-2008

CDISC define.xml Specifics Demo CDISC Pilot (Variable Metadata) CDISC Draft Metadata Submission Guidelines (Variable Metadata) CDISC German UG Meeting 02-Sep-2008

CDISC define.xml Specifics Demo CDISC Pilot (Controlled Terminology) CDISC Draft Metadata Submission Guidelines (Value Level Metadata) CDISC German UG Meeting 02-Sep-2008

FDA Reviewers‘ Feedback Standard disclaimer (NOT the general FDA view) Overall, data were suitable for reviewers‘ needs Value of SDTM depends on reviewers‘ training status Use define.xml comments to explain “CDISC jargon“ Integration of Reviewer‘s Guide recommended ADaM essential since SDTM not Analysis-Ready ADSL variables, e.g. treatment in each dataset Derived variables in SDTM helpful Use of SDTM based review tools CAVEAT: Results may not be reproducible based on sole SDTM (additional analysis flags to be considered) CDISC German UG Meeting 02-Sep-2008

FDA Reviewers‘ Feedback (continued) Use of SDTM Review Tool WebSDM SDTM compliance check SDTM/define.xml consistency check Graphical Patient Profiles Merge of core variables (e.g. sex, treatment) to domains Merge of SUPPQUAL to parent domains Export of combined data to other tools Reviewers at time of Pilot more familiar with other tools CDISC German UG Meeting 02-Sep-2008

FDA Reviewers‘ Feedback (continued) Data documentation via define.xml Concept, Content, Navigation, Reviewer‘s Guide  Printing  Sample for multiple-studies submission is missing FDA committed to standards Success of SDTM/ADaM depends on Training (implementers and reviewers) Experience (implementers and reviewers) Availability of suitable review tools CDISC German UG Meeting 02-Sep-2008

Summary and Conclusions Overall, data were suitable for reviewers‘ needs Very helpful implementation example No guidance => evolution of CDISC standards Importance of ADaM when submitting SDTM Familiarity with CDISC models is a key factor Implementer Reviewer Watch out for next pilot: multiple-studies safety data CDISC German UG Meeting 02-Sep-2008

References CDISC SDTM/ADaM Pilot Project – Project Report (SDTMADaMPilotProjectReport.pdf) Slides from the CDISC Pilot Webcast (bmc_cdisc_sdtm-adam_pilot_v-2.pdf) Cathy Barrow‘s presentation at CDISC EU IC 2008 (CDISC presentations website) Revised Pilot Submission Package as provided by CDISC (CDISC Members Only website) CDISC German UG Meeting 02-Sep-2008

Thank you! Questions?