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Danone Research, FRANCE Stephane AUGER A Coherent and Practical End-to-End Metadata Strategy using Existing Standards and Tools for Clinical Research.

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Presentation on theme: "Danone Research, FRANCE Stephane AUGER A Coherent and Practical End-to-End Metadata Strategy using Existing Standards and Tools for Clinical Research."— Presentation transcript:

1 Danone Research, FRANCE Stephane AUGER A Coherent and Practical End-to-End Metadata Strategy using Existing Standards and Tools for Clinical Research

2 CONTEXT  Clinical studies performed in 4 divisions  Dairy, Waters, Baby and Medical Nutrition  Historically  Mostly paper-based studies until very recently  DM Outsourced to CROs  Few internal data / metadata standards  Result  Few controls on data / metadata received from CROs  Lack of homogeneity between studies  Resource intensive to pool for meta analysis or format for a DR/DW

3 CONTEXT  2010  Upper management request for a “Data Warehouse” “First, we need to get more control over our clinical study metadata”  Thought process to address the end goal:  Use existing tools/software as much as possible  Standardize up front… CDISC SDTM, CDASH, ODM  A bonus if we could make metadata management and study set-up more efficient

4 Key Decision #1: Metadata Standards Management (1) 1.Manage Study Metadata Standards  CRF Forms, Item Groups, Items, Codelists  Item Characteristics (type, formats, range values etc.)  CRF completion guidelines / help text  Database structure  Based on SDTM/CDASH Implementation of a Study Metadata Modeler (SMM) … with a duel use

5 Key Decision #1: Metadata Standards Management (2) 2.Create Study-Specific Metadata  Use Metadata Library to create a study-specific “CRF”  Export study-specific “CRF” in ODM format to an EDC system → Requires ODM-compatible EDC system Implementation of a Study Metadata Modeler (SMM) … with a duel use

6 SMM Functionality SMM EDC ODM Visit Layout Simple Edit Checks Simple Edit Checks DB Structure CRF Custom Attributes IWRS Coding TSDV IWRS Coding TSDV Database Admin. Workflow Config. Complex Edit Checks Complex Edit Checks Custom Configuration

7 Key Decision #1: Metadata Standards Management (3) SMM - Implementation Experience  Define company standard CRF forms and variables Workgroups representing Clin Ops, QA, Statistics, Data Management 1 year – 80 man/days Resulted in a Data Standards Committee and change management process  Define standard DB structure in the SMM Each EDC has different production database specificities One library for multiple EDC systems SMM provider an essential resource 3 months – 60 man/days

8 Key Decision #2: ODM-Compliant EDC (1) 1.ODM-in  Import Study-Specific CRF metadata - ODM file 2.ODM-out  Export study metadata & study data in ODM Implementation of ODM-compliant EDC tool(s)

9 Study Set-up: What’s left to do? SMM EDC ODM Medical Coding Database Admin. Workflow Config. Complex Edit Checks Complex Edit Checks Visit Layout Simple Edit Checks Simple Edit Checks DB Structure CRF TSDV Custom Attributes

10 Key Decision #2: ODM-Compliant EDC (2) Implementation Experience  Many challenges to overcome and details to solve  SMM & EDC implementation at the same time  Requires tech-savy personnel  60-80% of the EDC study build is done automatically in this process  Main differences between our two EDC tools  Two-step ODM import process  Visit configuration  Complex edit checks need to be re-configured

11 Implementation Experience (2)  Impact on EDC budget?  75% decrease in professional service costs  62% decrease in overall EDC budget  Impact on Data Management Resources?  No Change in Study Build FTEs (but more tasks performed internally)  ≈50 decrease in study set-up time (Protocol to EDC Go-Live)  ≈ 20% increase in overall DM study budget (vs. Paper-based) Database & EDC Set-up CRF = EDC Set-up Reduced Programing Reduced Validation Key Decision #2: ODM-Compliant EDC (3) Metadata Control Standardization Efficiency Warehouse-ready data

12 Roles and Responsibilities EDC Vendor SMM EDC ODM In Workflow Config. Database Admin. Complex Edit Checks Complex Edit Checks CRF & Study Build Danone ( Data Manager) Danone ( Data Manager) In-Study DM Hosting & Support Validation Custom Config. / Reports Database Lock

13 Key Decision #3: ODM-Compliant Mapping Tool SMM EDC ODM Study Metadata Standards Study Build ODM ODM ??

14 Key Decision #3: ODM-Compliant Mapping Tool 1.Maps ODM (from the EDC) to produce:  SAS transport datasets (SDTM format)  Define.xml  Standardized ODM 2.Standard Mapping Metadata  Re-Usable mapping scripts  Validation = only once Implementation of ODM-compliant Mapping (ETL) tool

15 Data Repository? Key Decision #3: ODM-Compliant Mapping Tool ETL Mapping Tool ETL Mapping Tool EDC a ODM Define.xml SAS Datasets ODM EDC b ODM

16 Clinical Study Data & Metadata Flow: Tools Mapping (XML4Pharma) Mapping (XML4Pharma) Metadata Standards & Study Set-up (Formedix) Metadata Standards & Study Set-up (Formedix) Data Collection (EDC) (Medidata RAVE OpenClinica) Data Collection (EDC) (Medidata RAVE OpenClinica) METADATA METADATA + STUDY DATA Data Repository

17 Clinical Study Data & Metadata Flow: Management METADATA METADATA + STUDY DATA Metadata Standards & Management Metadata Standards & Study Set-up (Formedix) Metadata Standards & Study Set-up (Formedix) Mapping (XML4Pharma) Mapping (XML4Pharma) Data Collection (EDC) (Medidata RAVE OpenClinica) Data Collection (EDC) (Medidata RAVE OpenClinica) Data Repository

18 Clinical Study Data & Metadata Flow: Standards METADATA METADATA + STUDY DATA Metadata Standards & Study Set-up (Formedix) Metadata Standards & Study Set-up (Formedix) Mapping (XML4Pharma) Mapping (XML4Pharma) Data Collection (EDC) (Medidata RAVE OpenClinica) Data Collection (EDC) (Medidata RAVE OpenClinica) Data Repository ODM SDTM SDTM/CDASH Define.xml

19 Conclusion End-to-End metadata standardization and control is possible There are significant cost and time savings to be had! The tools and standards are ready and available NOW

20 Thank You!


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