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Dianne Reeves VCDE Presentation December 15, 2011

NCI caBIG® CRF Standards use in NCI CDMS MediData Rave. Dianne Reeves VCDE Presentation December 15, 2011. Harmonization and Data Standards. Harmonization of caDSR content through: Community consensus-based activities: Imaging (Critical Path) Case Report Form Initiatives (NCI, CDASH)

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Dianne Reeves VCDE Presentation December 15, 2011

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  1. NCI caBIG® CRF Standards use in NCI CDMS MediData Rave Dianne Reeves VCDE Presentation December 15, 2011

  2. Harmonization and Data Standards • Harmonization of caDSR content through: • Community consensus-based activities: • Imaging (Critical Path) • Case Report Form Initiatives (NCI, CDASH) • Ongoing harmonization activities within caDSR • Cardiovascular Imaging (FDA) • Extended use of Standards • HL7 – Clinical Interoperability Council, DAMs (CV, TB) • CDMS MediData Rave adoption throughout NCI Cooperative Groups • caBIG C3D Adopter sites • REDCap collaboration • Five other Institutes (80:20 rule) • PROCTCAE variables

  3. Our Community caDSR Contexts /Owning Groups • ACRIN (American College of Radiology Imaging Network) • caBIG (NCI cancer Biomedical Informatics Grid) caBIG • CCR (NCI Center for Cancer Research) • CDISC (Clinical Data Interchange Standards Consortium) • CIP (NCI Cancer Imaging Program) • CTEP (NCI Cancer Therapy Evaluation Program) • DCP (NCI Division of Cancer Prevention) • EDRN (NCI Early Detection Research Program) • NHLBI (National Heart, Lung and Blood Institute ) • NICHD (National Institute of Child Health and Development) • NIDCR (National Institute of Dental and Craniofacial Research) • NINDS (National Institute of Neurological Disorders and Stroke) • PS&CC (NCI Population Sciences & Cancer Control) • SPOREs (NCI Specialized Programs of Research Excellence)

  4. Our Community Data Elements - >46,000 Case Report Form Collections • DCP, caBIG, CCR, CTEP • CaBIG C3D Adopter has 25 Adopter sites, 180+ Satellite sites • All CRFs are built from CDEs imported into the central Library • All CRFs use data elements registered in caDSR • CTEP nearly 3000 CRFs and Templates (CDMS Project) • All CRFs are built from data elements registered in caDSR • All CRFs are (now) registered in FormBuilder • Move into CDMS via caDSR:Rave Object Cart • Use of Congruency Checker to document compliance • Nine Adult Cooperative Groups of content, consolidating to four • All Cooperative Group Phase collections targets for Rave

  5. Our Cooperative Group CDMS Community

  6. NCI caBIG® CRF Initiative

  7. Testing CRF Modules First trial under construction is Burkitts trial • Trial built in caDSR FormBuilder, using registered CDEs • Measure efficiencies gained through use of MediData Rave • Document changes dictated by MediData Rave • Insert the new data collection standards, measure impact • Use of Mandatory variables • Impact on other variables • Document ability of MediData Object Cart Importer to move content as built in FormBuilder into Rave Additional module testing needed for full set of core elements

  8. CRF Standards Rounds 1 - 5

  9. Questions?

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