Oracle Clinical and Remote Data Capture 4.

6
September 29th, 2009 Alastair Clewlow, Product Strategy Director Health Sciences Global Business Unit

Oracle Clinical and Remote Data Capture 4.6

Support for Flexible Studies

New Oracle Clinical interface defines and assembles CRF Books to support Flexible Studies RDC UI enhancements to support Flexible Studies in RDC Onsite

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

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 Entry Window

Upgraded Technology Stack Supported Upgrade Paths

Oracle Clinical Remote Data Capture 4.5.1, 4.5.2, 4.5.3 to 4.6

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

New RDC OnSite Multi-Patient Casebook

CRF Book Navigator

Defining the Interval Rules

Only Visits assigned to the Screening Only Visits assigned to the Screening Interval are displayed in the Visit LOV Interval are displayed in the Visit LOV

Response entered for Interval Response entered for Interval Rule Trigger Question Rule Trigger Question TREATMENT_GROUP TREATMENT_GROUP

Visits assigned to Interval are also now Visits assigned to Interval are also now displayed in the Visit LOV displayed in the Visit LOV

CRF Page-level access (by user role)

User As view

User Bs view

Display of Conditional Block

pink highlighting pink highlighting represents the represents the Source Question Source Question

green highlighting green highlighting represents the Target represents the Target Question Question

Begin & End Block Begin & End Block lines are displayed lines are displayed

Runtime Hidden Behaviour

Runtime Greyed Behaviour

Changing the response to a Source Question

Multi-Patient CRF Book Assignment

Patient Range Patient Range All Patients at Site All Patients at Site

All Patients for this Study All Patients for this Study

Patients Assigned to Book Patients Assigned to Book

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 all types: manual section, manual field, univariates and multivariates. Previously, this support was provided only for manual section discrepancies.

Prevent update of other discrepancies

a database-level configuration option is provided to prevent users of specified roles from updating discrepancies appearing as other.

Questions