Oracle Argus Safety English User's Guide Release 8.0

408 Pages·2016·10 MB·English

by  Oracle Corporation

Oracle® Argus Safety
English User's Guide
Release 8.0
E54656-02
August 2016
Oracle Argus Safety English User's Guide Release 8.0
E54656-02
Copyright © 2015,2016 Oracle and/or its affiliates. All rights reserved.
This software and related documentation are provided under a license agreement containing restrictions on
use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your
license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license,
transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse
engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is
prohibited.
The information contained herein is subject to change without notice and is not warranted to be error-free. If
you find any errors, please report them to us in writing.
If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it
on behalf of the U.S. Government, the following notice is applicable:
U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software,
any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users
are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and
agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and
adaptation of the programs, including any operating system, integrated software, any programs installed on
the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to
the programs. No other rights are granted to the U.S. Government.
This software or hardware is developed for general use in a variety of information management
applications. It is not developed or intended for use in any inherently dangerous applications, including
applications that may create a risk of personal injury. If you use this software or hardware in dangerous
applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other
measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages
caused by use of this software or hardware in dangerous applications.
Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of
their respective owners.
Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks
are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD,
Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced
Micro Devices. UNIX is a registered trademark of The Open Group.
This software or hardware and documentation may provide access to or information about content,
products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and
expressly disclaim all warranties of any kind with respect to third-party content, products, and services
unless otherwise set forth in an applicable agreement between you and Oracle. Oracle Corporation and its
affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of
third-party content, products, or services, except as set forth in an applicable agreement between you and
Oracle.

Contents
Preface............................................................................................................................................................... xix
Documentation Accessibility................................................................................................................... xix
Related Documents................................................................................................................................... xix
Checking My Oracle Support.................................................................................................................. xx
Conventions............................................................................................................................................... xx
1 Getting Started
Product Overview..................................................................................................................................... 1-1
Logging In and Out.................................................................................................................................. 1-1
Logging into the Argus Application............................................................................................... 1-1
User Password Complexity Enhancement..................................................................................... 1-2
About the Argus Home Page.................................................................................................................. 1-2
Additional Tabs........................................................................................................................................ 1-3
Quick Launch Toolbar....................................................................................................................... 1-3
Error Messages................................................................................................................................... 1-6
Searching for a Case........................................................................................................................... 1-6
Argus Insight Integration ................................................................................................................. 1-7
Sharing a Case Series......................................................................................................................... 1-7
Basic Features and User Actions...................................................................................................... 1-8
Sorting on Columns.................................................................................................................... 1-8
Field Justifications............................................................................................................... 1-9
Getting Help................................................................................................................................ 1-9
Changing Your Password....................................................................................................... 1-10
Entering Dates.......................................................................................................................... 1-11
Entering Multiple Language Text.......................................................................................... 1-12
Languages Supported in Argus Safety................................................................................. 1-12
2 Argus Affiliate Module
Argus Affiliate Module Information.................................................................................................... 2-1
3 Active Cases
Opening Active Cases............................................................................................................................. 3-1
v
4 Local Lock Functionality
Enabling Local Data Entry...................................................................................................................... 4-2
Local Fields.......................................................................................................................................... 4-2
References for Details on Local Case Data Lock Functionality...................................................... 4-5
Changes to Report Scheduling - Auto-Scheduling............................................................................ 4-6
Changes to Report Scheduling - Manual Scheduling....................................................................... 4-8
Outlier Processing.................................................................................................................................... 4-8
Upgrade Changes - Enabling Local Locking in Argus Safety......................................................... 4-9
Triggering Local Reports - Changes to the Report Generation Algorithm................................ 4-11
5 Case Form
Case Form Functions................................................................................................................................ 5-1
Case Form Features............................................................................................................................ 5-2
Using Password Acceptance Dialog Boxes............................................................................. 5-2
Initial Case Entry......................................................................................................................... 5-2
Argus Safety Case Form User Preferences.............................................................................. 5-6
General Tab......................................................................................................................................... 5-6
General Usage Information....................................................................................................... 5-7
Dynamic Workflow Indicators.................................................................................................. 5-7
General Tab: General Information Section.............................................................................. 5-8
General Information Fields................................................................................................ 5-8
General Tab: Study Information Section................................................................................. 5-9
Study Information Fields and Field Descriptions........................................................... 5-9
Study Restrictions............................................................................................................. 5-10
General Tab: Reporter Information....................................................................................... 5-11
Adding Reporter Information......................................................................................... 5-13
Reporter Lookup Dialog Box Fields............................................................................... 5-14
General Tab: Literature Information Section....................................................................... 5-15
Literature Information Fields and Field Descriptions................................................. 5-15
Patient Tab........................................................................................................................................ 5-16
Patient Tab: Patient Information............................................................................................ 5-16
Patient Information Fields............................................................................................... 5-16
Neonate Information Section.......................................................................................... 5-18
Pregnancy Information.................................................................................................... 5-18
Entering Current Medical Status.................................................................................... 5-18
Copying Patient Information from Reporter Information.......................................... 5-18
Patient Details Section............................................................................................................. 5-18
Patient Details Fields and Field Descriptions............................................................... 5-19
Entering Pregnancy Information.................................................................................... 5-20
Event Death Details................................................................................................................. 5-20
Other Relevant History Section............................................................................................. 5-21
Other Relevant History Fields and Field Descriptions............................................... 5-21
Lab Data Section....................................................................................................................... 5-23
Lab Data Fields and Field Descriptions......................................................................... 5-23
Using the Lab Data Section............................................................................................. 5-23
Arranging the Lab Test data........................................................................................... 5-25
Relevant Tests Section...................................................................................................... 5-25
vi
Patient Tab: Parent Information............................................................................................. 5-26
Parent Information Section.............................................................................................. 5-26
Other Relevant History Section...................................................................................... 5-27
Products Tab.................................................................................................................................... 5-28
General Usage Information.................................................................................................... 5-29
Time Measurement Fields............................................................................................... 5-29
Date of Mfr Field............................................................................................................... 5-30
Products Tab: Drug Tab.......................................................................................................... 5-30
Product Information Section.......................................................................................... 5-30
Product Indication Section.............................................................................................. 5-31
Quality Control................................................................................................................. 5-31
Product Details Section.................................................................................................... 5-33
Dosage Regimens Section................................................................................................ 5-34
Study Drug Information.................................................................................................. 5-35
Products Tab: Device Tab....................................................................................................... 5-36
Product Information Section........................................................................................... 5-36
Searching for Products..................................................................................................... 5-37
Entering Quality Control Information........................................................................... 5-40
Product Indication Section.............................................................................................. 5-41
Product Delivered by Device Section............................................................................ 5-45
Product Delivered by Device Fields and Field Descriptions...................................... 5-45
Device Information Section............................................................................................. 5-45
Device Information Fields and Field Descriptions...................................................... 5-45
Products Tab: Vaccine Tab..................................................................................................... 5-47
Product Information Section.......................................................................................... 5-47
Searching for Products..................................................................................................... 5-49
To perform a search in the Product Browser dialog box............................................ 5-49
WHO Drug Browser Search............................................................................................ 5-49
Entering Quality Control Information........................................................................... 5-51
Product Indication Section.............................................................................................. 5-52
Product Details Section.................................................................................................... 5-53
Vaccine Information Section........................................................................................... 5-53
Entering Vaccine Administration Information............................................................. 5-54
Entering Prior Adverse Events Information................................................................. 5-55
Vaccine History Section................................................................................................... 5-55
Events Tab........................................................................................................................................ 5-56
General Usage Information.................................................................................................... 5-56
Field Properties for Help Text/Default Labels............................................................ 5-58
Events Tab: Event Tab............................................................................................................. 5-59
Event Information Section............................................................................................... 5-60
Understanding the Diagnosis-Event Relationship...................................................... 5-61
Associating a symptom with a diagnosis...................................................................... 5-62
Using the MedDRA Browser.......................................................................................... 5-63
Configuring Regulatory Reporting Rules..................................................................... 5-63
Event Coding Section.............................................................................................................. 5-63
Seriousness Criteria Section................................................................................................... 5-64
Entering Death Details..................................................................................................... 5-64
vii
Entering Hospitalization Details.................................................................................... 5-65
Nature of Event Section................................................................................................... 5-66
Details Section................................................................................................................... 5-66
Events Tab: Event Assessment Tab....................................................................................... 5-66
Filtering in the Event Assessment Tab.......................................................................... 5-67
User Actions on the Event Assessment Tab.................................................................. 5-67
Analysis Tab..................................................................................................................................... 5-68
Case Analysis Section.............................................................................................................. 5-69
Using Auto Narrative Templates.......................................................................................... 5-69
Viewing Differences in Case Narratives....................................................................... 5-70
Case Summary Section............................................................................................................ 5-70
Analysis Tab: MedWatch Info Tab........................................................................................ 5-72
Guidelines to Selecting G3 Report Source Checkboxes.............................................. 5-73
Analysis Tab: BfArM Info Tab............................................................................................... 5-74
Analysis Tab: AFSSaPS Info Tab............................................................................................ 5-74
Activities Tab................................................................................................................................... 5-75
Activities Tab: Contact Log Section....................................................................................... 5-75
Generating Letters............................................................................................................ 5-77
Scheduling Action Items for Letters.............................................................................. 5-79
Opening a Message Editor.............................................................................................. 5-79
Activities Tab: Action Items Section...................................................................................... 5-80
Action Items Fields and Field Descriptions.................................................................. 5-80
Activities Tab: Routing Comments Section.......................................................................... 5-81
Routing Cases.................................................................................................................... 5-81
Returning Cases................................................................................................................ 5-82
Activities Tab: Case Lock/Close Section.............................................................................. 5-83
Locking a Case.................................................................................................................. 5-85
Unlocking a Case.............................................................................................................. 5-86
Setting the Focus for a Follow-up Event....................................................................... 5-88
Additional Information Tab.......................................................................................................... 5-89
Additional Info Tab Fields and Field Descriptions............................................................. 5-89
Searching for Documentum Links......................................................................................... 5-91
Attaching Files to a Case......................................................................................................... 5-91
To attach files to a case..................................................................................................... 5-91
Entering Keywords.................................................................................................................. 5-91
Attaching References to a Case.............................................................................................. 5-92
Regulatory Reports Tab.................................................................................................................. 5-92
General Usage Information.................................................................................................... 5-92
Regulatory Report Tab Fields and Field Descriptions....................................................... 5-93
Grouping Regulatory Reports................................................................................................ 5-94
Grouping by Report Type/Submit Category/Reporting Destination..................... 5-94
Grouping by Report Type/Reporting Destination...................................................... 5-95
Grouping by Report Type/Reporting Group............................................................... 5-95
6 Case Actions
Working with Cases................................................................................................................................. 6-1
Finding and Opening Existing Cases.............................................................................................. 6-1
viii
General Usage Information....................................................................................................... 6-2
Case Open Form Fields and Field Descriptions..................................................................... 6-2
Search Results Contents............................................................................................................. 6-3
Sharing a Case Series.................................................................................................................. 6-3
Processing a Case............................................................................................................................... 6-4
Initial Case Entry Fields and Field Descriptions.................................................................... 6-5
Booking in Cases and Entering Initial Case Information...................................................... 6-6
Checking for Duplicates............................................................................................................. 6-9
Understanding Receipt Range Limits...................................................................................... 6-9
Closing a Case..................................................................................................................................... 6-9
Saving a Case................................................................................................................................... 6-10
Copying a Case................................................................................................................................ 6-10
Using the Medical Review Function............................................................................................ 6-11
Common Actions..................................................................................................................... 6-11
Using the Medical Review Tab.............................................................................................. 6-12
About the Case Narrative Section.................................................................................. 6-13
About the Case Assessment Section.............................................................................. 6-13
About the Event Assessment Section............................................................................. 6-13
Using Temporal View Tab...................................................................................................... 6-15
About the Summary Section........................................................................................... 6-16
About the Display Options Section................................................................................ 6-16
About the Event Assessment Section............................................................................. 6-17
About the Relevant Tests Section................................................................................... 6-18
Using the Action Items/Additional Info Tab...................................................................... 6-18
About the Contact Log Section....................................................................................... 6-18
Generating Letters............................................................................................................ 6-19
Scheduling Action Items for Letters.............................................................................. 6-20
Opening a Message Editor.............................................................................................. 6-20
About the Action Items Section...................................................................................... 6-21
About the Notes and Attachments Section................................................................... 6-21
Using the Coding Review Function............................................................................................. 6-22
General Information................................................................................................................ 6-22
Product Information................................................................................................................ 6-23
Event Information.................................................................................................................... 6-23
Death Information.................................................................................................................... 6-23
Patient Information.................................................................................................................. 6-24
Lab Data.................................................................................................................................... 6-24
Parent Information................................................................................................................... 6-24
Case Analysis............................................................................................................................ 6-25
Common Buttons Available in Coding Review.................................................................. 6-25
Using the Action Item Tab............................................................................................................. 6-26
Action Item Fields and Field Descriptions........................................................................... 6-26
Using the Print Function................................................................................................................ 6-27
Accessing Print Medical Summary Functions..................................................................... 6-27
Printing a Case................................................................................................................................. 6-28
Printing a Case.......................................................................................................................... 6-28
Viewing and Printing Letters................................................................................................. 6-29
ix
Viewing and Printing Attachments....................................................................................... 6-29
Transmitting a Case................................................................................................................. 6-30
Printing a Medical Summary......................................................................................................... 6-30
Deleting a Case................................................................................................................................ 6-31
Viewing Case Revisions................................................................................................................. 6-32
7 Advanced Conditions
Advanced Conditions.............................................................................................................................. 7-1
About the Advanced Condition Screen.......................................................................................... 7-2
Filtering for Existing Advanced Conditions........................................................................... 7-3
Viewing Results from Existing Advanced Conditions.......................................................... 7-4
Working with Advanced Conditions.............................................................................................. 7-5
Creating, Viewing or Modifying Advanced Conditions....................................................... 7-5
About the Advanced Condition Set Dialog Box..................................................................... 7-5
Additional Information about Properties................................................................................ 7-6
Sharing Advanced Conditions.................................................................................................. 7-8
Using Advanced Conditions..................................................................................................... 7-8
Creating an Advanced Condition Query Set.......................................................................... 7-9
Renaming Query Sets.......................................................................................................... 7-9
Using the Hit List Tab............................................................................................................. 7-10
8 Worklist
About Worklist.......................................................................................................................................... 8-1
General Usage Information.............................................................................................................. 8-1
Worklist Filtering............................................................................................................................... 8-2
Worklist Options................................................................................................................................ 8-2
New and Open............................................................................................................................ 8-3
General Usage Information................................................................................................ 8-3
Search Case........................................................................................................................... 8-3
Filtering Functions............................................................................................................... 8-4
Total Number of Rows........................................................................................................ 8-4
Routing Details..................................................................................................................... 8-7
Workflow Options............................................................................................................................. 8-7
Worklist User Options................................................................................................................ 8-7
Worklist Action Items........................................................................................................................ 8-9
General Usage Information....................................................................................................... 8-9
Query Management................................................................................................................. 8-10
Query Action Items.................................................................................................................. 8-10
Search Case............................................................................................................................... 8-11
Filter Function.......................................................................................................................... 8-12
Total Number of Rows..................................................................................................... 8-12
Coding Action Items....................................................................................................................... 8-13
Search Case............................................................................................................................... 8-13
Filter Functions......................................................................................................................... 8-14
Total Number of Rows............................................................................................................ 8-14
Contacts............................................................................................................................................ 8-15
Search Case............................................................................................................................... 8-15
x