CDM SIAC All Hands Call Rhonda Facile Director, CDASH Project CDISC CDISC Webinar Series: From Collection to Submission – Efficiently Mapping between CDASH and SDTM CDISC Webinar Series: From Collection to Submission – Efficiently Mapping between CDASH and SDTM CDM SIAC All Hands Call Thursday, November 19, 2009 10:00 AM EST Part 2- Mapping from CDASH to Submission (SDTM) Data Sets 3 September 2009 Part 2- Mapping from CDASH to Submission (SDTM) Data Sets 3 September 2009 Rhonda Facile Gary Walker Director, CDASH Project, CDISC Quintiles Transnational Corp. Associate Director, Enterprise Data Standards Shannon Labout Consultant Lauren Shinnaberry Senior Project Manager, PRA International Rhonda Facile Director, CDASH Project CDISC Rhonda Facile Director, CDASH Project, CDISC Gary Walker Associate Director, Enterprise Data Standards Quintiles Transnational Corp. Shannon Labout Consultant Lauren Shinaberry Senior Project Manager, PRA International 1

CDISC Snapshot Global, open, multi-disciplinary non-profit organization Founded in 1997; incorporated in 2000 Over 200 member organizations Biopharmaceutical companies Academic Research Institutes Technology Vendors, etc… Active Coordinating Committees Europe Japan Additional activities Australia India S. America and Africa Established industry standards to support the electronic acquisition, exchange, submission and archiving of data to support regulated clinical research Freely available on the CDISC website (www.cdisc.org) Developed through open, consensus-based approach 2

Project Snapshot Critical Path Opportunity #45 - Streamlines data collection at investigative sites Continuation of ACRO’s Initiative Started October 2006 Supported by a collaborative group of 17 organizations Core team of 16 members manages.. 11 working groups Comprised of between 8-40 volunteers ~190 working group volunteers 18 Safety data domains developed Consolidated document posted for public review in May 2008 Received over 1800 comments from 46 companies, institutions and agencies. All 3 ICH regions were represented in the public comment process US Europe Japan CDASH V1.0 published October 2008 3 3

Critical Path Opportunity Projects Initiated During 2006 Streamlining Clinical Trial Data Collection Opportunity #45 Private efforts to streamline clinical trial data collection through voluntary standardization of case report forms (CRFs) have recently been formalized under the auspices of the Clinical Data Acquisition Standards Harmonization (CDASH) Initiative. Catalyzed by the Clinical Data Interchange Standards Consortium and the Association of Contract Research Organizations, dozens of product sponsors, investigators, data managers and other stakeholders are working together to agree on a core set of data collection fields to support clinical research studies (i.e., creation of consensus CRFs and implementation guides for four "safety data/domains": adverse events, prior medications, concomitant medications, demographics and subject characteristics). FDA is providing input on issues as requested (e.g., FDA requirements). The CDASH process is open to any participant and will include a public comment process (see www.cdisc.org ). http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077251.htm

Collaborative Group Members American Medical Informatics Association (AMIA) Association of Clinical Research Organizations (ACRO) Association of Clinical Research Professionals (ACRP) Baylor College of Medicine Biotechnology Industry Organization (BIO) Clinical Data Interchange Standards Consortium (CDISC) Clinical Research Forum Critical Path Institute Duke Clinical Research Institute (DCRI) Food and Drug Administration (FDA) NIH - NCI - caBIG NIH - Clinical Research Policy Analysis & Coordination Program National Clinical Research Resources (NCRR) NIH - National Institute of Child Health & Human Development (NICHD) National Library of Medicine (NLM) Pharmaceutical Research and Manufacturers Association (PhRMA) Society for Clinical Data Management (SCDM) 5

CDASH Project Scope Develop content standards for a basic set of global industry-wide CRF fields to support clinical research element name definition metadata Initial scope limited to most commonly collected data These CRF standards apply across all therapeutic areas and phases of clinical development (I-IV) Follow CDISC defined standards development process. 6

Practical Benefits Eliminate some of the variety in CRFs Supports common understand Enables better quality data collection Reinforces collecting only key data Reduces collection of duplicate data - decreasing the potential for error Minimizes data queries Shortens study start time Facilitates the population of CRFs via an eHR (without re-entry) Allows implementers to map efficiently to SDTM 7 7

CDISC Standards Development Process Primary Stages Stage I: Standard Definition/Approval Multidisciplinary Team Initiation; Working Plan Development Stage II: Standards Development-Consensus Model Reviews by Focused Group and Open Public; Harmonization and Testing throughout; V1.0 Release Stage III: Education & Support Stage IV: Standards Update & Maintenance

CDASH Domains Common Identifier Variables Common Timing Variables Adverse Events (AE) Concomitant Medications (CM) Comments (CO) Drug Accountability (DA) Demographics (DM) Disposition (DS) Protocol Deviations (DV) ECG (EG) Exposure (EX) Inclusion Exclusion (IE) LAB Test Results (LB) Medical History (MH) Physical Exam (PE) Vital Signs (VS) Subject Characteristics (SC) Substance Use (SU) 9

CDASH Domain Tables How to BRIDG Mappings Question Text & Prompts to V 1.1 1 2 3 4 5 6 Data Collection Field Variable Name (CDASH variable name shaded) Definition Case Report Form Completion Instructions Additional Information for Sponsors CDASH Core Basic data to be collected How to implement the CRF data collection variable Describes the purpose of the data collection field Can be either a topic description or the Question text. SDTM-IG based variable name (CDASH) (Variable name shaded) CRF Completion Instructions for Sites CDASH Core Designations

Key Collaborations CDISC cross-team collaboration SDS Team - SDTM Controlled Terminology Team BRIDG Team Collaboration with NIH-NCI-caBIG project Standardized cancer-specific CRF fields + CDASH basic data collection fields (safety+efficacy data!) Healthcare – CDASH Link allows electronic patient data to flow directly from the eHR into CDASH CRFs

Caveat – work done by volunteers, many dependencies! Next Steps Update CDASH v. 1.0 (v.1.1) CDASH-User Guide (CDASH-UG) Machine Readable Metadata (CDASH-ODM) AdvaMed-CDISC Device Project Target Q110 – early Q210 Caveat – work done by volunteers, many dependencies!

CDASH Core Team Members Rhonda Facile rfacile@cdisc.org Gary Walker gary.walker@quintiles.com Dorothy Dorotheo DDorotheo@intermune.com Paul Bukowiec Paul.Bukowiec@mpi.com Trisha Simpson Trisha.Simpson@UCB-group.com Shannon Labout shannon@labout.net Liz Nulton-Bodiford liz.m.nulton-bodiford@gsk.com Jay Leeka Jay.Leeka@astrazeneca.com Alec Vardy a.vardy@exelixis.net Kim Truett Kim.Truett@kctdm.com Kit Howard kit@kestrelconsultants.com Lorna Griffin lorna_griffin1@merck.com Lauren Shinnaberry ShinaberryLauren@PRAIntl.com Melissa Binz binzm@wyeth.com

CDASH Core Team Members Charlene Dark charlene.dark@i3statprobe.com Jennifer Price jennifer.price@bioclinica.com Chandra Wooten Chandra.Wooten@gilead.com Jerry Salyers JSalyers@OCTAGONRESEARCH.com Matt Leary mleary@logicalpro.com Dawn Kaminski DKaminski@OCTAGONRESEARCH.com Dan Crawford DCrawford@OCTAGONRESEARCH.com Kathryn Hanson khanson@csscomp.com Casey Higgins Casey.Higgins@OmnicareCR.com Melissa Cook Melissa.Cook@MPI.com David Borbas David.Borbas@jazzpharma.com Grace Kao GraceKao@westat.com Joris DeBondt Joris.debondt@sgs.com Kesi Sanders Kesi_sanders@rhoworld.com

CDASH Core Team Members Martha Schmidt Martha_schmidt@merck.com Priya Gopal Priya.gopal@parexel.com Quyen Nuyen quyen@innoventz.com Young Kim Ykim@pharmanet.com Rachel Richardsson Rachel.Richardsson@epi.usf.edu Brooke Hinkson Brooke.Hinkson@genzyme.com Valeria Paxton vpaxton@synteract.com Cynthia Baxter cynthiabaxter@metagenics.com + Domain Team Members……

Questions??

Strength through collaboration.