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Oracle Clinical and Remote Data Capture 4.6September 29th, 2009
Alastair Clewlow, Product Strategy Director
Health Sciences Global Business Unit
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Oracle Clinical and Remote Data Capture 4.6
Support for Flexible Studies
New Oracle Clinical interface defines and assembles CRFBooks to support Flexible Studies
RDC UI enhancements to support Flexible Studies in RDCOnsite
Usability Enhancements CRF Page Level Access
In-Page Conditional and Indicator Branching in RDC OnSite
Multi-Patient CRF Book Assignment
Discrepancy Management Enhancements in RDC Onsite
Patient Data Report Enhancements
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Oracle Clinical and Remote Data Capture 4.6
Scalability Enhancements
24/7 Support for RDC Data Entry and Batch Validation Improved Middle Tier Scalability for RDC Onsite
Handling Intermittent Drops in the RDC Onsite Data EntryWindow
Upgraded Technology Stack Supported Upgrade Paths
Oracle Clinical Remote Data Capture 4.5.1, 4.5.2, 4.5.3 to 4.6
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New interface to define and assemble CRF
Books to support Flexible Studies
Enhanced CRF Book
Copy CRF Book within a Study Copy Visits within a CRF Book
Interval Rule Definition
CRF Rule Definition Page renumber utility
Validate CRF Book
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New RDC OnSite Multi-Patient Casebook
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CRF Book Navigator
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Defining the Interval Rules
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Only Visits assigned to the ScreeningInterval are displayed in the Visit LOV
Only Visits assigned to the ScreeningInterval are displayed in the Visit LOV
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Response entered for IntervalRule Trigger Question
TREATMENT_GROUP
Response entered for IntervalRule Trigger Question
TREATMENT_GROUP
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Visits assigned to Interval are also nowdisplayed in the Visit LOV
Visits assigned to Interval are also nowdisplayed in the Visit LOV
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CRF Page-level access (by user role)
User As view
User Bs view
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Display of Conditional Block
pink highlightingrepresents the
Source Question
pink highlightingrepresents the
Source Question
green highlightingrepresents the Target
Question
green highlightingrepresents the Target
Question
Begin & End Block
lines are displayed
Begin & End Block
lines are displayed
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Runtime Hidden Behaviour
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Runtime Greyed Behaviour
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Changing the response to a Source Question
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Multi-Patient CRF Book Assignment
Patient RangePatient Range All Patients at SiteAll Patients at Site
All Patients for this StudyAll Patients for this Study Patients Assigned to BookPatients Assigned to Book
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Discrepancy Management Enhancements
in RDC OnSite
Hidden discrepancies
The ability to hide discrepancies at a specific status from
users with a certain role is extended to discrepancies of alltypes: manual section, manual field, univariates andmultivariates. Previously, this support was provided only formanual section discrepancies.
Prevent update of other discrepancies a database-level configuration option is provided to prevent
users of specified roles from updating discrepanciesappearing as other.
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