1. 1 What do Forms Curators Do? Architecture/VCDE Joint Face-to-Face June 4, 2010 St. Louis, Missouri Tommie Curtis Brenda Maeske Mary Cooper

2. 2 Agenda Overview number of groups using the caDSR and FormBuilder Key concepts of the forms curation process Demonstrate form curation process Review questionnaire curation process Future and going forward

3. Contexts Contributing to caDSR Source of ContentcaBIG Applications Standard Data Dictionary ProtocolsCase Report Forms QuestionnairesResearch Studies Manually Curated UML Models caBIG XXXXXX caCORE XXX CCR XXXX CDISC XXXXXX CIP XXXXX CTEP XXX DCP XXX EDRN XX NHLBI XXX NIDCR XXX PS&CC XXXXXXX SPORES XXX 3

4. Distribution of caDSR Administered Items 4

5. Number of caDSR Curators 40 Trained Curators 15-20 Currently Active 8 Curate in more than one Context 5

6. caCORE Training Provided in both self-paced and web-based training sessions Teaches how caDSR fits into the caCORE Infrastructure How to use the caDSR Tools to find, download, evaluate and create Common Data Elements (CDEs) for Case Report Forms (CRFs) and UML Models New Curators have a 3 month precepting relationship with an experienced curator Register for caCORE and other CBIIT training offerings through the caBIG® Learning Management System (LMS).caBIG® Learning Management System (LMS) 6

7. Generic Form Curation Process Choose best process for metadata registration – manual curation vs a model Search for reusable existing metadata content (concepts, DEC, VD, CDE) – use as is or modify Determine concepts to use to build new metadata – use current concepts or request new concepts Use tools to create DEC, VD, and DE – the time for this step varies with complexity of components, reuse percentage, and skill of curator Create form in Formbuilder Review and release 7

8. Cancer Therapy Evaluation Program (CTEP) 186 Clinical Trials Documented and in FormBuilder ACOSOB 10 CALGB32 ECOG52 [20 or so are OPEN Registration Worksheet only] GOC15 IBSCG 3 NCIC-CTG 7 NSABP11 RTOG21 SWOG30 *Note – A single trial can have many CRFs 8

9. Division of Cancer Prevention (DCP) 45 Trials currently in OC-RDC 5 Trials in CRF review process 6 Lead Organizations 80-100 Participating Organizations 2,639 Participant Records in OC- RDC 9

10. Center for Cancer Research (CCR) 250 Clinical Trials in C3D 56 Collaborative Sites Additional sites such as Harvard and Louisiana State University are evaluating C3D adoption. 10

11. C3D Adopters More than 70 Adopters 300+ Trials Thousands of Patients Approximately 1,000 Users 11

12. Groups Using caDSR NCI Organizations - Division of Cancer Control and Population Sciences (DCCPS), Division of Cancer Treatment and Diagnosis (DCTD), Division of Cancer Epidemiology and Genetics (DCEG) NIH Organizations - National Institute of Child Health and Development (NICHD), National Institute of Dental and Craniofacial Research (NIDCR), National Heart Lung and Blood Institute (NHLBI), The Cancer Genome Atlas (TCGA) Standards Organizations - Health Information Technology Standards Panel (HITSP), North American Association of Central Cancer Registries (NAACCR), Clinical Data Interchange Standards Consortium (CDISC) Research Partners - National Marrow Donor Program (NMDP) Commercial Partners – Caris Life Sciences, KAI Research, Novartis Universities – Duke Cardiovascular and Tuberculosis Projects 12

13. Case Report Form Manual Curation Example 13

14. Manual Curation - Forms Approach Search caDSR for existing metadata Identify new items for curation Request new concepts from EVS Consult with SME to vet metadata Curate variables in the caDSR by building contextual information - concepts alone are not enough Create form in FormBuilder Provide Excel spreadsheet to Protocol Builders to build study in OC-RDC caBIG adopters using C3D –Protocol Builders set up the trials –Assess the need for new CDEs –Curator imports CDEs into C3D 14

15. DCP Registration Paper Case Report Form (pCRF) 15

16. Search CDE Browser for Existing CDEs 16 Standard CRF Modules

17. FormBuilder DCP Template Registration Form 17

18. FormBuilder DCP Template Registration Form (cont.) 18

19. FormBuilder DCP Template Registration Form (cont.) 19

20. DCP OC-RDC Registration Electronic Case Report Form (eCRF) 20

21. Questionnaires UML Model Example 21

22. Curating Questionnaires Other forms of data collection instruments used in clinical research and behavioral oncology research Large surveys −Health Information National Trends Survey (HINTS) −National Health Interview Survey (NHIS) Smaller Behavioral Measures Questionnaires −Subjective Numeracy Scale (SNS) −Perceived Stress Scale (PSS) −FACT-G (Functional Assessment of Cancer Therapy- General) −Minneapolis-Manchester QOL Survey of Health (MMQL) 22

23. Curating Questionnaires Approach Follows the same process as described for the Case Report Form Example Analyze source document/Choose appropriate curation method Create working spreadsheet/Develop UML model Search caDSR for existing metadata Identify new items for curation Consult with SME to vet metadata Register metadata in caDSR Unique considerations 23

24. Grid Enabled Measures - GEM A Grid-Enabled, interoperable, dynamic website of behavioral and social science Measures This website allows researchers to −search constructs and associated measures −submit −download −receive and provide feedback −share data Courtesy Richard P. Moser, Ph.D. Behavioral Research Program, Division of Cancer Control and Population Sciences 24

25. GEM Website 25 Courtesy of Westat and DCCPS

26. GEM Model 26

27. Perceived Stress Scale 27 Curation challenges Capturing concepts Respecting validity/reliability Definitions Likert Scales in value domains Value meaning concepts Data Types

28. Perceived Stress Scale 28

29. NHIS 2005 – Adult Health Behavior 29

30. NHIS 2005 – Smoking Related Data 30

31. NHIS 2005 – caDSR (CDE Browser View) 31

32. Summary 32 Manual Curation and UML Models are both being used to create metadata for forms and questionnaires CDEs are important to the forms community; vocabularies (concepts) alone do not capture the contextual information about data files Reusability of existing metadata content moves toward harmonization for forms The large clinical trials community will continue to need support Need for forms and model community to work together to support tooling and infrastructure

33. Questions 33