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Designing_an_OC_Compliant_Paper_CRF

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Designing_an_OC_Compliant_Paper_CRF

  1. 1. 13th Annual OCUG Conference October 12-15, 2008Premier Research Group Ltd. Designing an OC Compliant Paper Case Report Form (CRF) Maureen Medeiros
  2. 2. Objectives This presentation will… • Illustrate how OC Compliant CRFs save time and money • Provide a paper Forms tool update • Exemplify paper CRF Objects with matching OC Objects • Explain Library Management in OC and TELEform • Demonstrate how to Maintain standardization 2
  3. 3. Agenda 1 OC Compliancy1. OC Compliancy 2 Library Management2. Library Management 3 Consistency and Standardization3. Consistency and Standardization 4 S d Q ti4. Summary and Questions 3
  4. 4. 1a. Why design an OC Compliant paper CRF?CRF? • Efficiencyy • Decrease Data Management issues • Save time • Cost • Less man-power requiredp q • Save money G• Globalization • Across clinical trials • Industry compliancyIndustry compliancy 4
  5. 5. 1b. How will you design an OC Compliant paper CRF?paper CRF? • These are the 5 leading tools available today. • Choose software specializing in form production• Choose software specializing in form production. CRF DESIGN TOOLS OC 4.5.1 Quark XPress 8 TELEform Designer V10.2 Adobe InDesign CS4 Microsoft Office Word 20078 V10.2 CS4 Word 2007 5
  6. 6. TELEform layout - Shape Library - #1 TELEform Designer V10.2 DEMG module – CRF Design with OC in mind – order of fieldsorder of fields 6
  7. 7. OC Character Layout GLIB Menu Path- #1 OCOC 4.5.1 Access DEMG DCM page to modify and match CRF DEMG modulemodule 7
  8. 8. OC Character Layout from GLIB - #1 OCOC 4.5.1 DEMOG DCM – Same order as the paper CRF Ideally, little to no editing required Efficiency: saves time! 8
  9. 9. TELEform layout - Shape Library - #2 TELEform Designer V10.2 CDRG module - CRF Design with OC restrictions in mindin mind - Repeating QG structure can be d iprogrammed in OC 9
  10. 10. OC Character Layout from GLIB - #2 OCOC 4.5.1 CDRG DCM -Repeating QG is OC Compliant – DB Development– DB Development Error! - Label not consistent with paper CRF Efficiency: Decrease Data 10 Management issues
  11. 11. TELEform – Non-Compliant - #3 TELEform Designer V10.2 1st repeating QG CDRG DCM -Repeating QG is OC CompliantOC Compliant 2nd repeating QG Non-compliant ‘Reason’ field is missing 11
  12. 12. 2a. How do you manage your Libraries? • OC’s GLIB is separated by domain with standard objects• OC s GLIB is separated by domain with standard objects in each domain. The paper ‘CRF Library’ should be separated into these same domains (i.e. therapeutic area, )compound, sponsor, etc.) • A formal approval and/or QC should be in place for all• A formal approval and/or QC should be in place for all NEW objects needed on a CRF • Train CRF Designers in OC to BRIDGE the gap between paper CRF Design and OC DB Build 12
  13. 13. 2b. BRIDGE between paper CRF Design and OC DB DevelopmentOC DB Development BRIDGE the gap between both library’s objects: OC’s Global Library bj t CRF Library bj t objectsobjects DB d l tProtocol CRF Design DB development 13
  14. 14. 3. How can we maintain consistency and standardization?standardization? • CRF Design 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. • Adopt a naming convention - i.e. the CDISC (Clinical Data Interchange Standards Consortium) – FDA recommendedInterchange Standards Consortium) FDA recommended 14
  15. 15. 4. Summary and Questions Designing an OC Compliant Paper CRF 1. OC Compliancy • Tools • Matching objects 2 Lib M2. Library Management • OC compliance • Bridge• Bridge 3. Consistency and Standardization • Reuse approved objectsj • CDISC 15
  16. 16. “Thank you!” Maureen Medeiros Maureen.Medeiros@premier-research.comMaureen.Medeiros@premier research.com 617-237-1135 16

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