Oracle® Argus Safety Japanese Administrator's Guide Release 7.0.3

42 Pages·2015·3.39 MB·English

by  Oracle Corporation

Oracle® Argus Safety
Japanese Administrator’s Guide
Release 8.0
E54655-01
January 2015
Oracle Argus Safety Japanese Administrator's Guide, Release 8.0
E54655-01
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Contents
Preface................................................................................................................................................................. v
Intended Audience...................................................................................................................................... v
Documentation Accessibility..................................................................................................................... v
About This Book.......................................................................................................................................... v
Conventions................................................................................................................................................. v
1 Introduction
2 Business Configuration
2.1 Configuring Product Family..................................................................................................... 2-1
2.2 Configuring Licenses.................................................................................................................. 2-1
2.2.1 PMDA Device Reporting Support in Console................................................................. 2-1
2.2.2 Literature Intake Updates................................................................................................... 2-3
2.3 Configuring Studies.................................................................................................................... 2-5
2.4 Configuring Expedited Reporting Rules................................................................................. 2-5
3 System Configuration
3.1 Configuring Commmon Profile Switches............................................................................... 3-1
3.1.1 Common Profile Switches.................................................................................................. 3-1
3.1.1.1 Profile Switch for Incompletion Report Submission - Auto Action item ......... 3-12
3.2 Configuring Field Level Validations..................................................................................... 3-13
3.2.1 Field Label Configuration (J Specific)............................................................................ 3-13
3.2.1.1 PMDA Downgrade/nullification Report Scenario when All Events are
Non-Reportable 3-14
3.3 Configuring Field Labels........................................................................................................ 3-15
3.3.1 User Defined Fields Updates.......................................................................................... 3-15
3.4 Configuring Local Reports - Local Reporting Rule and Local Reports........................... 3-15
4 Code List Configuration
4.1 Code Lists..................................................................................................................................... 4-1
4.1.1 General Functionality Changes......................................................................................... 4-1
4.1.2 Device Reporting Category................................................................................................ 4-2
4.1.3 Emperor................................................................................................................................. 4-2
4.1.4 J Reportable Product Keyword.......................................................................................... 4-3
4.1.5 License Category.................................................................................................................. 4-4
iii
4.1.6 Literature Type..................................................................................................................... 4-5
4.1.7 Reporting Category............................................................................................................. 4-6
4.1.8 Literary Citation................................................................................................................... 4-7
4.1.9 Manufacturers...................................................................................................................... 4-8
4.1.10 Reporter Information....................................................................................................... 4-10
iv
Preface
This document describes the steps for installing and configuring the components of
the Argus Console (Japanese) application.
Intended Audience
This document is intended for administrators of the Argus J Safety system for
configuring Argus Safety.
Documentation Accessibility
For information about Oracle's commitment to accessibility, visit the Oracle
Accessibility Program website at
http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.
Access to Oracle Support
Oracle customers have access to electronic support through My Oracle Support. For
information, visit
http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit
http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are
hearing impaired.
About This Book
This guide contains the following chapters:
Chapter1, "Introduction"
Chapter2, "Business Configuration"
Chapter3, "System Configuration"
Chapter4, "Code List Configuration"
Conventions
The following text conventions are used in this document:
v
Convention Meaning
boldface Boldface type indicates graphical user interface elements associated
with an action such as Buttons, Dialog boxes, Check boxes, Combo
boxes, Drop-down lists, Labels, Option (Radio) buttons, Tabs, Text
boxes, etc.
"between quotation Information that may appear as-is on screen, or information provided
marks" by the user.
Note Information that should be noted before proceeding with the
instructions.
Important Important information that must be noted to ensure accurate, reliable,
or safe behavior of the system.
Tip Information that enables easier completion of the current task or helps
in completing other tasks.
Bold Underline Link indicating that additional "pop-down" information is available.
ALL CAPITALS Keyboard keys
Initial Capitals Names of user interface elements, modules, applications, proper nouns,
etc.
vi
1
Introduction
1
This guide lists the Japanese-specific (J-specific) features in Argus Console.
These features have been covered as per the modules where they are displayed, in the
following chapters:
■ Business Configuration
■ System Configuration
■ Code List Configuration
Introduction 1-1
Introduction 1-2
2
Business Configuration
2
This chapter lists lists the Japanese-specific (J-specific) features in the Business
Configuration module of Argus Console.
2.1 Configuring Product Family
The following is the list of changes in Product Family Configuration:
Product Family Configuration: "Comments (J)" text area field has been added right
below the English "Comments" text area:
This field is displayed to only an Argus J user when Japanese module is enabled.
It is printed in the Product Family Configuration print PDF right after the English
Comments field.
It is audit-logged and is covered by the back-end PL/SQL APIs for Product Family
Configuration data table updates and audit-logging.
2.2 Configuring Licenses
The following is the list of changes in License Configuration:
2.2.1 PMDA Device Reporting Support in Console
The following is the list of changes for PMDA Device Reporting Support in Console:
1. Three new dropdown fields have been added to Console > Business Configuration
> Products and Licenses.
a. These dropdowns list fixed dropdown options, as specified below in the same
order.
PMDA Device Classification 1:
High Level Controlled Medical Device
Controlled Medical Device
Generic Medical Device
PMDA Device Classification 2:
Biogenous
Specific Biogenous
Other
Business Configuration 2-1
Configuring Licenses
PMDA Device Classification 3:
Single Use Medical Device
Reiteration Use Medical Device
Figure 2–1 Console License Configuration - PMDA Device Classifications
b. These fields have <Blank> as the default value for these drop-down lists.
c. These fields are displayed to only an Argus J user when Japanese module is
enabled.
d. These fields are editable only when Authorization Country is selected as Japan
and License Type is selection as either of "Marketed Device " or
"Investigational Device". Otherwise, these are displayed as blank and
disabled.
e. The dropdown option values are displayed in English even to the Argus J user
as this is an English base screen. The Japanese value specified for these
dropdowns is used to populate these in PMDA Device Expedited Form 8 and
10.
f. Existing fields - "Medical Device Information" and "Clinical Compound
Number" have been adjusted in the user interface of the application.
g. These three fields are printed in License Print PDF in three different rows,
right below Clinical Compound Number field in alternate-colored rows
thereafter.
h. These fields are audit-logged.
i. These fields are covered by the back-end PL/SQL APIs for License
Configuration data table updates and audit-logging.
Business Configuration 2-2