Alastair OC-RDC NNIT Only]

8/2/2019 Alastair OC-RDC NNIT Only]

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Oracle Clinical and Remote Data Capture 4.6September 29th, 2009

Alastair Clewlow, Product Strategy Director

Health Sciences Global Business Unit


2/19

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


3/19

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


4/19


5/19

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


6/19

New RDC OnSite Multi-Patient Casebook


7/19

CRF Book Navigator


8/19

Defining the Interval Rules


9/19

Only Visits assigned to the ScreeningInterval are displayed in the Visit LOV

Only Visits assigned to the ScreeningInterval are displayed in the Visit LOV


10/19

Response entered for IntervalRule Trigger Question

TREATMENT_GROUP

Response entered for IntervalRule Trigger Question

TREATMENT_GROUP


11/19

Visits assigned to Interval are also nowdisplayed in the Visit LOV

Visits assigned to Interval are also nowdisplayed in the Visit LOV


12/19

CRF Page-level access (by user role)

User As view

User Bs view


13/19

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


14/19

Runtime Hidden Behaviour


15/19

Runtime Greyed Behaviour


16/19

Changing the response to a Source Question


17/19

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


18/19

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.


19/19

Questions

Documents

Alastair OC-RDC NNIT Only]