Paper crf design_tools
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This presentation discusses paper case report form (CRF) design tools. It reviews various CRF design software options and their key features. It emphasizes establishing a standardized "CRF library" using OC's Global Library objects. The presenter recommends designing paper CRFs that consider the database structure and match OC screenshots to promote consistency between paper and electronic CRFs. The goal is to bridge the gap between paper CRF design and electronic database build. The presentation provides guidance on selecting appropriate CRF design tools and standardizing a paper CRF library that is compatible with OC.
Paper crf design_tools
- 1. 12th Annual OCUG Conference Premier Research October 7-10, 2007 Paper Case Report Form (CRF) Design Tools Maureen Medeiros
- 2. Objectives This presentation will… • Review CRF Design Tools that may be used with OC’s GLIB • Discuss today’s leading applications in this industry • Illuminate Features and detail Usability of each tool • Touch upon Print Layout Quality and Cost of each tool • Create your own paper ‘CRF Library’ 2
- 3. Agenda 1. Form Design Software Assessment 2. Design Tool Key Features 3. Develop & Maintain Your ‘CRF Library’ 4. Summary and Questions 3
- 4. 1. Form Design Software Assessment 1a.) What is form design software? 1b.) What are the CRF format Pros & Cons? 1c.) Which are the top technologies? 4
- 5. 1a.) What is form design software? • It is a software product used to develop CRFs for the collection of subject trial data. • Form design software are platforms especially manufactured with explicit page layout capabilities. (i.e. blank spaces for data insertion) • CRFs are functionally designed for: 1. recording data on the form 2. data entry into the computer 3. data retrieval for analysis 5
- 6. 1b.) What are the CRF format Pros & Cons? CRF Pros Cons Format Paper • Usability ~ Less Difficult • Cost ~ Higher • Print Layout Quality ~ High • Industry ~ Not Preferred • CRF Design Aesthetics ~ High • Build DB / CRF ~ Separately • IT issues ~ Less • ‘CRF Library’ ~ Develop • CRF objects ~ Develop Electronic • Cost ~ Lower • Usability ~ More Difficult • Industry ~ Preferred • Print Layout Quality ~ Low • Build DB / CRF ~ Simultaneously • CRF Design Aesthetics ~ Low • OC Global Library ~ Available • IT issues ~ Greater • GLIB objects ~ Approved / Reuse 6
- 7. 1c.) Which are the top technologies? • These are the 5 leading tools available today. • Choose a tool specializing in form production. CRF DESIGN TOOLS Quark TELEform Adobe Microsoft OC XPress Designer InDesign Office 4.5.0 6.5 V8.1 CS3 Word 2007 7
- 8. OC User Interface OC 4.5.0 This is a screen shot of OC’s toolbar layout in the Graphical Layout Editor (GLE). 8
- 9. OC example CRF – draft OC 4.5.0 This is the same CRF Adverse Event (AE) page produced directly from OC’s GLE with approved Global Library objects. 9
- 10. OC example CRF – final OC 4.5.0 This is the same CRF AE page as OC’s print-ready CRF in PDF format with header and footer. 10
- 11. Quark User Interface Quark XPress 6.5 This is a screen shot of Quark’s toolbar layout. 11
- 12. Quark example CRF Quark XPress 6.5 This is Quark’s print-ready CRF with customized QuarkXTensions modules with a header and footer. 12
- 13. TELEform User Interface TELEform Designer V8.1 • Do you recognize the menu structure? • Some of TELEform’s toolbar buttons or icons are identical to those you see in other Windows-based programs. This is a screen shot of TELEform’s toolbar layout. Save Print Delete Font Go to Previous Page Go to Next Page Text Rectangle Comb Field Choice Field Smart Text Image Zone Horizontal/Vertical Line Constrained Print Field 13
- 14. TELEform example CRF TELEform Designer V8.1 This is TELEform’s CRF in PDF format with Shape Library modules with a header and footer. 14
- 15. 2. Design Tool Key Features 2a.) Which key features are for you? 2b.) How do your features compare? 2c.) What are the overall Pros & Cons? 15
- 16. 2a.) Which key features are for you? > Study Type > Usability > Print Layout Quality > Cost 16
- 17. 2b.) How do your features compare? KEY OC OC QUARK Quark TELEform TELEform XPress Designer Features 4.5 6.5 v8.1 Study • Paper • Paper • Paper Type • Electronic • Electronic • Electronic Usability • Training • Training • Training • Global Library • XTensions modules • Shape Library • OC interface • Windows interface • Windows interface • RDC & GLE • Form Controls • Form Toolbar • Build DB / CRF • Traditional order • Traditional order Print • Many steps • Print-ready • Print to PDF Layout • PDF quality • Excellent quality • PDF quality Quality • Add software • Inclusive software • Add software Cost • Negligible • Moderate price • Expensive • Use OC 4.5 • Use design features • Use form features 17
- 18. 2c.) What are the overall Pros & Cons? OC QUARK TELEform Quark TELEform OC XPress Designer 4.5 v8.1 6.5 Pros • Cost • Print Layout Quality • Form toolbar • GLIB approved • Usability • Shape Library • Build DB / CRF • Inclusive software • Use form features Cons • Usability • Cost • Cost • Add software • Library development • Add software • IT issues • Creative design tool • Only form design 18
- 19. 3. Develop & Maintain Your ‘CRF Library” 3a.) How do you establish and standardize a paper ‘CRF Library’? 3b.) How can paper CRFs consider DB design and reuse of OC’s GLIB objects? 3c.) Should paper CRFs match OC screenshots of the same CRF? 19
- 20. 3a.) How do you establish and standardize a paper ‘CRF Library’? • Remember: Your CRF is designed to collect complete clinical trial study data and to ensure data standardization and consistency across all participating investigational sites. • OC’s GLIB is separated by domain with standard objects in each domain. Your paper ‘CRF Library’ should be separated into these same domains (therapeutic area, compound, sponsor, etc.). • A formal approval and / or Quality Control (QC) process should be in place for all new objects needed on a CRF. • Adopt a naming convention - i.e. the CDISC (Clinical Data Interchange Standards Consortium) 20
- 21. 3b.) How can paper CRFs consider DB design and reuse of GLIB objects? • Train CRF Designers in OC to BRIDGE the gap between paper CRF Design and OC DB Build • Design the CRF with OC’s GLIB and with OC compatibility and restrictions in mind • Matching the CRFs with OC’s objects easily promotes a standard ‘CRF Library’ and reuse of objects • OC’s GLIB enforces standard questions and QG. Therefore, CRFs should enforce the same standards. 21
- 22. BRIDGE between paper CRF Design and OC DB Build BRIDGE the gap between both library’s objects: ‘CRF OC’s Global Library’ Library objects objects Protocol CRF Design CRF Annotation / DB development 22
- 23. 3c.) Should paper CRFs match OC screenshots of the same CRF? • Paper CRFs may or may not match the Data Entry (DE) screen. • In many cases, DE guidelines and study-specific training are needed to avoid errors in DE. • Benefits of the BRIDGE are: 1. easier data entry with fewer errors. 2. less study-specific training and guidelines are required. 23
- 24. Example - Paper CRF Library object Paper ‘CRF Library’ object - (PD) Repeating group 24
- 25. Example - OC GLIB object OC GLIB object – (PD) Repeat question 1 of 3 25
- 26. 4. Summary and Questions 1. Form Design Software Assessment 1a.) What is form design software? 1b.) What are the CRF format Pros & Cons? 1c.) Which are the top technologies? 2. Design Tool Key Features 2a.) Which key features are for you? 2b.) How do your features compare? 2c.) What are the overall Pros & Cons? 3. Develop & Maintain Your ‘CRF Library” 3a.) How do you establish and standardize a paper ‘CRF Library’? 3a.) How can paper CRFs consider DB design and reuse of GLIB objects? 3c.) Should paper CRFs match OC screenshots of the same CRF? 26
- 27. Paper Case Report Form (CRF) Design Tools Maureen Medeiros Maureen.Medeiros@premier-research.com 27