Clinical Document Architecture Implementations - Lessons Learnt to Date
Designing_an_OC_Compliant_Paper_CRF
1. 13th Annual OCUG Conference
October 12-15, 2008Premier Research Group Ltd.
Designing an OC Compliant
Paper Case Report Form (CRF)
Maureen Medeiros
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
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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
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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
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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
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TELEform
Designer
V10.2
Adobe
InDesign
CS4
Microsoft
Office
Word 20078 V10.2 CS4 Word 2007
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6. TELEform layout - Shape Library - #1 TELEform
Designer
V10.2
DEMG module
– CRF Design
with OC in mind –
order of fieldsorder of fields
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7. OC Character Layout GLIB Menu Path- #1
OCOC
4.5.1
Access DEMG DCM
page to modify and
match CRF DEMG
modulemodule
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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!
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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
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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
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Management issues
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
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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
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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
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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
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