Presentation on theme: "CDASH Initiative: Status Update"— Presentation transcript:
1 CDASH Initiative: Status Update Bay Area CDISC Implementation Network Meeting - May 29, 2008Rhonda Facile, Project Director, CDISCDorothy B. Dorotheo, InterMuneMark Wheeldon, Formedix
2 Snapshot OverviewCDASH Purpose & ScopeWho Participated in CDASHHow CDASH Developed?CDASH Domains – Where are we?CDASH Domains – New IdeasCDASH Variable MetadataCDASH Core DesignationsPractical Implementation of CDASH within CDISC ODMCDASH Goals
3 SnapshotCritical Path Opportunity #45 – Streamline data collection at investigative sites.Continuation of ACRO’s InitiativeStarted October 2006Supported by a Collaborative Group of 17 organizationsCore team of 15 members manages..11 working groupsGroups with between 8-40 volunteers~190 work group volunteers + additional reviewers (both nationally and internationally)16 Safety data domains developed..organized in 4 “Packages”Draft consolidated document now out for public review – April 2008
4 CDASH Purpose & ScopeTo develop a set of ‘content standards’ (element name, definition, metadata) for a basic set of global industry-wide data collection fields that support clinical research.The initial scope - ‘safety data/domains’.These safety domains cut across all therapeutic areas (TA independent).Follow CDISC Operating Procedure for Standards Development (COP-001).
5 Who Participated in CDASH? Team membership:StatisticiansMedical Monitors/Clinical ScientistsRegulatory AffairsDrug SafetyData ManagersClinical Study CoordinatorsClinical Research AssociatesInvestigatorsClinical Program ManagersStatistical ProgrammersDatabase programmersMore multi-national input welcome.Participants in the CDASH InitiativeOther = Academic Research Organizations,Government (NIH, NCI), Hospitals, Universities.
6 How was CDASH Developed? Start with Study Data Tabulated Model (SDTM)Focus on CRF Content, not CRF LayoutRefer to ACRO CRF Samples (where available)Collect CRF samplesEvaluate commonalities/differences of CRF samplesDocument data points included/excluded with justifications
7 How was CDASH Developed? Agree on basic data collection fieldsMap to SDTMTerminology - proposals shared with the Terminology TeamWrite definitions and completion instructions for clinical site and SponsorsProceed to the next step in the Consensus Process
8 CDASH Domains – Where we are Package-1:AECMDMSCStarted Oct 06Package 3:DAEXCODVDSStarted Mar 07Package-2:IEMHSUPEVSStarted Dec 06Package-4:LBEGStarted Jul 07Consensus(Initial)VersionHarmon-izedReleased(Production)1.0ReviewTLCCollaborativeGroupOKPublicPublished & Out for Public Review – April 2008
9 CDASH Variable Metadata Question text for collection on the CRF.How toimplementthe CRFdata collection variableDescribes the purpose of the data collection fieldSDTM-IG conforming variable name(CDASHvariables shaded)Aka CRFCompletion InstructionsCDASH Core Designations
10 CDASH Core Designations Highly RecommendedA data collection field that should be on the CRF (e.g., a regulatory requirement (if applicable)). (e.g. Adverse Event Term)Recommended/ConditionalA data collection field that should be collected on the CRF for specific cases (may be recorded elsewhere in the CRF or from other data collection sources). (e.g. AE Start Time)OptionalA data collection field that is available for use if needed. (e.g. Were there any AE Experienced?)In SDTM, there are also 3 categories, REQUIRED, EXPECTED & PERMISSIBLEThe two standards initiatives do not have same purpose/goal:SDTM is for submission, and CDASH is for data collection. There is not a one to one match in most cases.Highly recommended —fields that really need to be collected; basic fields that are or need to be collected on a CRFRecommended/conditional —collected on the CRF for specific cases e.g. collecting time for precision like in a phase 1 study when patients are confined in the study unit and it is impt. in analysis or it may be derived from other fields…less strong a recommendationOptional —a fields available for your use if your protocol needs it.
11 CDASH Domain – New Ideas Physical Examination (PE)Use PE form to record only whether or not exam was doneInstruct Sites to record,Baseline Abn.: MH, Targeted MH or Baseline Conditions CRFs.Post baseline abn. or baseline conditions that worsened on AE CRFInclusion/Exclusion (IE)Use IE form to collect only the criterion or criteria NOT MET for Inclusion/Exclusion criteria
12 CDASH Domain – New Ideas Protocol Deviations (DV)Avoid creating a protocol Deviations CRF because this information can often be derived from other CRF domains or system functionalities.Comments (CO)Avoid the creation of a General Comments CRF which collects unsolicited comments.
13 “Practical Implementation of Clinical Data Acquisition Standards (CDASH) in the CDISC Operational Data Model”Mark Wheeldon, CEO, FormedixBay Area User Group, 29th May, 2008
14 Who are we? Involved with Standards since 2001 All our solutions are based on Open CDISC StandardsCDISC Products and Consultancy CompanyPlanning, Preparation and Implementation CDISC ServicesProducts so you can use CDISC in house!Product Focus is on Study Specification and Design ToolsOrigin™ authoring tools to streamline Protocol to Submission ProcessDatabase Specification uses CDISC Operational Data ModelOrigin Study Modeller™Submission Specification uses CDISC Define.xmlOrigin Submission Modeller™Must work with and around existing processes/technologiesOperational Data Model for EDC auto generationExisting internal analysis and reporting structuresNew or existing extract, transfer and load tools
15 How could CDASH be used today? Use as a Content StandardOff the shelf Case Report Form contentDescribes relationship between Operational Data and Submission DatasetsCDASH represented within a proprietary file formatExcel, Word, Proprietary EDC system formatPotentially unstructuredUse within Machine Readable MetadataCDASH represented in CDISC Operational Data ModelVendor neutral system independent formatHierarchical structure is ideal for re-usable library of Components
16 Benefits of using CDASH within the CDISC Models Library DevelopmentCDASH forms represented in CDISC Database StandardSafety Domains in CDISC Submission StandardStudy SpecificationUsing CDISC metadata to reduce study set-up timeAutomation of Electronic Data Capture BuildUsing CDISC ODM to reduce study build timesOptimize Downstream DataflowOperational data to submissionReduces mapping complexityMakes mappings re-usable
18 What is CDASH? What is it Not? Content Standard NOT a ModelDatabase Variable Name, Definition, Question TextInstructions to the Site, SDTM Variable MappingCore Designations is a killer featureGive clinical context on why something is collectedHighly Recommended, Recommended/Conditional, OptionalClinical Perspective on data collectionWhat is it not?One to one mapping with the SDTMAEYN not in SDTMAEBODSYS not in CDASH
19 ODM Building Blocks How does CDASH Relate? Clinical DatabaseVariable NameControlled TerminologyCDASH CRFLabel/QuestionCDASH Core(Highly Recommended)
20 CDASH Adverse Event Form in ODM No more hand building of this…
21 A Dedicated Authoring Environment for Each Standard… Origin Study Modeller™Origin Submission Modeller™
27 Optimal Solution from Standardized Content to any EDC System I have an alternative to this diagram – this is new. Good because it brings in libraries ……
28 Optimizing Downstream Dataflows CDASH vs. Non CDASH Form Differences 112233445566
29 Optimizing Downstream Dataflows CDASH vs Non CDASH SDTM Differences 115454662233
30 Conclusions CDASH-ODM Delivers Today Library DevelopmentCDASH brings clinical perspectiveCDASH links to SDTM to bring a submission perspectiveQuickly settle disputes over contentStreamline Study Set-up and EDC Build ProcessEliminate manual study specificationStudy Spec from 492 hrs down to 158 hrs (3x shorter)30-40% build time reductionsDownstream Raw Data to Submission Dataflow OptimisationConsistency between Operational Data and Submitted DatasetsReduction in mapping complexity – quick to createMappings easier to maintain
31 CDASH Goals Finalize and Post CDASH final draft for public review CDASH Roadshow & Training program.Finalize and Post CDASH V. 1.0 on CDISC.org.Develop and Publish CDASH-ODM metadataEstablish subgroup, Scope, Deliverables, Participants and TimelinesIdentify and Collect feedback from “Early Implementers”“CDASH” New SDTM Domains as required.
32 Strength through collaboration. PLEASE VOLUNTEER!!!3232