London, United Kingdom 28th – 29th April 2010 Session 2, 11:00 - 12:30 CDASH – Right from the Beginning Chair: Niels Both Getting the Most out of CDASH, Metadata and Terminology Joris De Bondt, Data Management Coordinator SGS Life Science Services â 2009 Outline ã CDASH, Metadata and Terminology Past • Focus on 16 CDASH domains (therapeutic agnostic) – Present • Additional guidance is available in the CDASH User Guide (e.g rules that define conformance and instructions for creating fields) – Future • Opportunities when using CDASH, metadata and terminology from the beginning © 2009 CDASH in the past • Many benefits – CDASH provides benefits for the site and monitors • efficient CRF data completion and efficient monitoring – CDASH solves a number of SDTM challenges • standard CRF pages have standard SDTM annotations • reduce the need for sponsor-specific controlled terminology – CDASH reduces eCRF set-up time for eCRF-tools with library capabilities • Drag and drop CDASH forms into the study design – CDASH is a key-item for a true end-to-end CDISC implementation © 2009 CDASH in the past • But even more questions – Can we define additional CDASH domains ourselves? – Can we customize the 16 CDASH domains? – What is required to be CDASH compliant? – What’s the experience of others with CDASH? ã CDASH is a work-in-progress ! â 2009 CDASH at present • CRF customization seems to be in our nature: – Can we turn the vertical structure into a horizontal structure? – Can we change the order of the CDASH fields? – Can we mix fields from one domain with another? • So, the question is: “What is CDASH conformance? â 2009 CDASH at present: conformance rules ã Conformance to the CDASH standard is described at levels – Tier conformance • Describes the minimum implementation – Tier conformance ã Focus on the operational implementation â 2009 CDASH at present: conformance rules • Tier conformance • All Highly Recommended and applicable Recommended / Conditional fields are present in the CRF • All code lists displayed in the CRF use or map to current published CDISC Controlled Terminology • The implementation follows the Best Practice recommendations for creating data collection instruments = FAQ list with 12 items • CDASH Question Text or Prompt is used © 2009 CDASH at present: conformance rules • Tier conformance • All Level conformances are met • All data collection fields are defined using CDASH naming conventions in the operational database • All non-CDASH fields in CRF follow CDASH recommendations for ‘creating fields that not exist in CDASH’ • All Best Practice recommendations are followed © 2009 CDASH at present • Answers – Can we define additional CDASH domains ourselves? • Yes, the CDASH user guide provides instructions – Can we customize the 16 CDASH domains? • Using subsets, changing the field order and mixing fields across domains is allowed – What is required to be CDASH compliant? • Comply with CDASH conformance rules in the CDASH user guide – What’s the experience of others with CDASH? • That’s what CDISC interchanges are for! © 2009 CDASH at present: Implement now • Take advantage of CDASH-ODM files • Create a library with the CDASH-ODM files in your CRF design tool • Add completion instructions to all CDASH fields => generate the Completion Guidelines document when the CRF design is done â 2009 CDASH at present: Implement now ã CDASH implementation – End-to-end tracebility till SDTM great EDC features • Some EDC systems allow built-in AE-CM linking (split screen) – But CDASH naming cannot be applied for this RELREC data – Trade-off: User friendly © 2009 full CDASH compliance CDASH in the future • Getting the Most out of CDASH, Metadata and Terminology: opportunities – case studies: • Metadata repository ã Drug safety and clinical research â 2009 CDASH in the future: Case • Typical flow from CDASH to SDTM SDTM CDASH (+define.xml and annotated CRF) Extract-Transform-Load Standard eCRF © 2009 Standard ETL code Standard SDTM CDASH in the future: Case • Typical flow from CDASH to SDTM – Benefits • Easy creation of SDTM datasets via standard ETL code – Drawbacks • The metadata (define.xml) only comes into the picture at the end of the trial, when preparing the submission package • Metadata from the beginning could help to confirm accuracy of the trial database, especially when dealing with adaptive trials • The metadata remains on a study level => a unique source of information on a cross-trial level is ignored • Solution: add a dimension to your trials: Metadata Repository © 2009 CDASH in the future: Case • Add a new dimension to your trials: – Use Metadata from the start • Pull the CRF forms for all your trials out of a metadata repository into the CRF design tool Metadata Repository © 2009 CDASH in the future: Case • Add a new dimension to your trials: – Use Metadata during the trial • Verify consistency of your trials before Go-Live • Use the metadata repository to update the trial design in case of protocol amendments • Store the trial metadata in the metadata repository for future reference Metadata Repository © 2009 CDASH in the future: Case • Add a new dimension to your trials: – Use Metadata till the end • Use the trial metadata in the metadata repository to generate SDTM datasets Metadata Repository © 2009 CDASH in the future: Case • Enhanced flow: Metadata all the way Metadata Repository © 2009 CDASH in the future: Case • Enhanced flow: Metadata all the way – Benefits • Full control over the trial metadata from the start till the end • A metadata repository provides a unique source of information on a cross-trial level © 2009 CDASH in the future: Case • Drug safety clinical research – Remove the barrier between Drug Safety and Clinical Research • CDASH could include the data fields typically submitted in an Individual Case Safety Report (ICSR) • Content of ICSR is known as E2B – By creating CDASH – E2B mappings • Mapping exercise for 320 fields is ongoing © 2009 CDASH in the future: Case • Drug safety & clinical research – huge time-savers • Automatic upload of SAE reports in safety databases • Automated SAE reconcilation of the clinical database with the safety database via SDTM – E2B mapping © 2009 CDASH in the future: Case • Drug safety & clinical research – Flowchart: SDTM CDASH Source: CDASH portal © 2009 E2B Conclusions – CDASH user guide provides answers – CDASH conformance includes the operational level – End-to-end (CRF-to-SDTM) tracebility – Metadata all the way – Integrated CDISC process generates opportunities © 2009 Thank you for your attention • Questions? • Contact information: – Joris De Bondt joris.debondt@sgs.com www.sgs.com/CRO © 2009 Strength through collaboration © 2009 26 ... © 2009 full CDASH compliance CDASH in the future • Getting the Most out of CDASH, Metadata and Terminology: opportunities – case studies: • Metadata repository • Drug safety and clinical research... © 2009 CDASH in the future: Case • Typical flow from CDASH to SDTM SDTM CDASH (+define.xml and annotated CRF) Extract-Transform-Load Standard eCRF © 2009 Standard ETL code Standard SDTM CDASH. .. conformance and instructions for creating fields) – Future • Opportunities when using CDASH, metadata and terminology from the beginning â 2009 CDASH in the past ã Many benefits – CDASH provides