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

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?