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12th Annual OCUG Conference
Premier Research                October 7-10, 2007




Paper Case Report Form (CRF) Design Tools

Maureen Medeiros
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
Agenda


1. Form Design Software Assessment

2. Design Tool Key Features

3. Develop & Maintain Your ‘CRF Library’

4. Summary and Questions


                    3
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
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
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
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
OC User Interface
                                                   OC
                                                  4.5.0




This is a screen shot of OC’s toolbar layout in the
Graphical Layout Editor (GLE).


                          8
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
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
Quark User Interface                             Quark
                                                XPress
                                                  6.5




 This is a screen shot of Quark’s toolbar layout.


                          11
Quark example CRF                            Quark
                                            XPress
                                              6.5




This is Quark’s print-ready CRF with customized
QuarkXTensions modules with a header and footer.


                        12
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
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
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
2a.) Which key features are for you?

> Study Type

> Usability

> Print Layout Quality

> Cost




                         16
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
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
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
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
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
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
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
Example - Paper CRF Library object




Paper ‘CRF
 Library’
 object -
   (PD)
Repeating
  group




                    24
Example - OC GLIB object




OC GLIB
object –
  (PD)
 Repeat
question
 1 of 3



                   25
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
Paper Case Report Form (CRF) Design Tools




              Maureen Medeiros
    Maureen.Medeiros@premier-research.com




                     27

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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