Oracle Argus Safety English User's Guide

414 Pages·2016·11.13 MB·English

by  Oracle Corporation

Oracle® Argus Safety
User's Guide
Release 8.1
E70262-01
September 2016
Oracle Argus Safety User’s Guide Release 8.1
E70262-01
Copyright © 2016 Oracle and/or its affiliates. All rights reserved.
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Contents
Preface............................................................................................................................................................... xix
The Oracle Health Sciences Safety Suite................................................................................................ xix
Documentation Accessibility................................................................................................................... xx
Related Documents................................................................................................................................... xx
Checking My Oracle Support.................................................................................................................. xxi
Conventions............................................................................................................................................... xxi
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
Using Null Flavor Data........................................................................................................... 1-12
Entering Multiple Language Text.......................................................................................... 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 Information................................................................................................................... 5-8
General Information Fields................................................................................................ 5-8
Study Information....................................................................................................................... 5-9
Study Information Fields and Field Descriptions........................................................... 5-9
Study Restrictions............................................................................................................. 5-10
Reporter Information............................................................................................................... 5-11
Adding Reporter Information......................................................................................... 5-13
Reporter Lookup Dialog Box Fields............................................................................... 5-14
Literature Information Section............................................................................................... 5-15
Literature Information Fields and Field Descriptions................................................. 5-15
Patient Tab........................................................................................................................................ 5-16
Patient Information.................................................................................................................. 5-16
Patient Information Fields............................................................................................... 5-17
Entering Current Medical Status.................................................................................... 5-18
Copying Patient Information from Reporter Information.......................................... 5-19
Patient Details........................................................................................................................... 5-19
Patient Details Fields and Field Descriptions............................................................... 5-19
Entering Pregnancy Information -.................................................................................. 5-20
Event Death Details................................................................................................................. 5-21
Other Relevant History........................................................................................................... 5-22
Other Relevant History Fields and Field Descriptions............................................... 5-22
Lab Data.................................................................................................................................... 5-24
Lab Data Fields and Field Descriptions......................................................................... 5-24
Using the Lab Data Section............................................................................................. 5-25
Arranging the Lab Test data........................................................................................... 5-27
Relevant Tests Section............................................................................................................. 5-27
Parent Information................................................................................................................... 5-27
Other Relevant History.................................................................................................... 5-28
vi
Products Tab.................................................................................................................................... 5-28
General Usage Information.................................................................................................... 5-29
Time Measurement Fields............................................................................................... 5-29
Date of Mfr Field............................................................................................................... 5-30
Drug Tab................................................................................................................................... 5-30
The Product Information Section................................................................................... 5-30
The Product Indication Section ...................................................................................... 5-32
The Quality Control Section............................................................................................ 5-32
The Dosage Regimens Section........................................................................................ 5-33
The Product Details Section............................................................................................ 5-34
Study Drug Information.................................................................................................. 5-36
The Device Tab......................................................................................................................... 5-36
Product Information Section........................................................................................... 5-36
Searching for Products..................................................................................................... 5-41
Entering Quality Control Information........................................................................... 5-44
Product Indication Section.............................................................................................. 5-45
Product Delivered by Device Section............................................................................ 5-46
Product Delivered by Device Fields and Field Descriptions...................................... 5-46
Device Component Information..................................................................................... 5-46
Device Information Section............................................................................................. 5-47
Device Information Fields and Field Descriptions...................................................... 5-47
Vaccine Tab............................................................................................................................... 5-49
Product Information Section.......................................................................................... 5-49
Searching for Products..................................................................................................... 5-51
To perform a search in the Product Browser dialog box............................................ 5-51
WHO Drug Browser Search............................................................................................ 5-52
Product Indication Section.............................................................................................. 5-53
Quality Control Section................................................................................................... 5-53
Vaccine Information Section........................................................................................... 5-55
Product Details Section.................................................................................................... 5-55
Vaccine Administration ................................................................................................. 5-55
Prior Adverse Events ..................................................................................................... 5-57
Vaccine History Section................................................................................................... 5-57
Events Tab........................................................................................................................................ 5-58
General Usage Information.................................................................................................... 5-58
Field Properties for Help Text/Default Labels............................................................ 5-61
Event.......................................................................................................................................... 5-62
Event Information Section............................................................................................... 5-62
Understanding the Diagnosis-Event Relationship...................................................... 5-64
Associating a symptom with a diagnosis...................................................................... 5-64
Using the MedDRA Browser.......................................................................................... 5-65
Configuring Regulatory Reporting Rules..................................................................... 5-65
Event Coding Section.............................................................................................................. 5-66
Seriousness Criteria Section................................................................................................... 5-66
Entering Death Details..................................................................................................... 5-67
Entering Hospitalization Details.................................................................................... 5-67
Nature of Event Section................................................................................................... 5-68
vii
Details Section................................................................................................................... 5-69
Event Assessment.................................................................................................................... 5-69
Filtering in the Event Assessment Tab.......................................................................... 5-70
User Actions on the Event Assessment Tab.................................................................. 5-70
Product-Event Details Tab...................................................................................................... 5-71
Analysis Tab..................................................................................................................................... 5-72
Case Analysis Section.............................................................................................................. 5-72
Using Auto Narrative Templates.......................................................................................... 5-73
Viewing Differences in Case Narratives....................................................................... 5-74
Case Summary Section............................................................................................................ 5-74
Analysis Tab: MedWatch Info Tab........................................................................................ 5-75
Guidelines to Selecting G3 Report Source Checkboxes.............................................. 5-77
Analysis Tab: BfArM Info Tab............................................................................................... 5-78
Analysis Tab: AFSSaPS Info Tab............................................................................................ 5-78
Activities Tab................................................................................................................................... 5-79
Activities Tab: Contact Log Section....................................................................................... 5-79
Generating Letters............................................................................................................ 5-81
Scheduling Action Items for Letters.............................................................................. 5-83
Opening a Message Editor.............................................................................................. 5-83
Activities Tab: Action Items Section...................................................................................... 5-84
Action Items Fields and Field Descriptions.................................................................. 5-84
Activities Tab: Routing Comments Section.......................................................................... 5-85
Routing Cases.................................................................................................................... 5-85
Returning Cases................................................................................................................ 5-86
Activities Tab: Case Lock/Close Section.............................................................................. 5-87
Locking a Case.................................................................................................................. 5-89
Unlocking a Case.............................................................................................................. 5-90
Setting the Focus for a Follow-up Event....................................................................... 5-92
Additional Information Tab.......................................................................................................... 5-93
Additional Info Tab Fields and Field Descriptions............................................................. 5-93
Searching for Documentum Links......................................................................................... 5-95
Attaching Files to a Case......................................................................................................... 5-95
To attach files to a case..................................................................................................... 5-95
Entering Keywords.................................................................................................................. 5-95
Attaching References to a Case.............................................................................................. 5-96
Regulatory Reports Tab.................................................................................................................. 5-96
General Usage Information.................................................................................................... 5-96
Regulatory Report Tab Fields and Field Descriptions....................................................... 5-97
Grouping Regulatory Reports................................................................................................ 5-98
Grouping by Report Type/Submit Category/Reporting Destination..................... 5-98
Grouping by Report Type/Reporting Destination...................................................... 5-99
Grouping by Report Type/Reporting Group............................................................... 5-99
6 Case Actions
Working with Cases................................................................................................................................. 6-1
Finding and Opening Existing Cases.............................................................................................. 6-1
General Usage Information....................................................................................................... 6-2
viii
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..................................................................................................................... 6-12
Using the Medical Review Tab.............................................................................................. 6-12
About the Case Narrative Section.................................................................................. 6-13
About the Case Assessment Section.............................................................................. 6-14
About the Event Assessment Section............................................................................. 6-14
Using Temporal View Tab...................................................................................................... 6-15
About the Summary Section........................................................................................... 6-16
About the Display Options Section................................................................................ 6-17
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....................................................................................... 6-19
Generating Letters............................................................................................................ 6-20
Scheduling Action Items for Letters.............................................................................. 6-21
Opening a Message Editor.............................................................................................. 6-21
About the Action Items Section...................................................................................... 6-21
About the Notes and Attachments Section................................................................... 6-22
Using the Coding Review Function............................................................................................. 6-22
General Information................................................................................................................ 6-23
Product Information................................................................................................................ 6-23
Event Information.................................................................................................................... 6-24
Death Information.................................................................................................................... 6-24
Patient Information.................................................................................................................. 6-24
Lab Data.................................................................................................................................... 6-25
Parent Information................................................................................................................... 6-25
Case Analysis............................................................................................................................ 6-26
Common Buttons Available in Coding Review.................................................................. 6-26
Using the Action Item Tab............................................................................................................. 6-27
Action Item Fields and Field Descriptions........................................................................... 6-27
Using the Print Function................................................................................................................ 6-28
Accessing Print Medical Summary Functions..................................................................... 6-28
Printing a Case................................................................................................................................. 6-29
Printing a Case.......................................................................................................................... 6-29
Viewing and Printing Letters................................................................................................. 6-30
Viewing and Printing Attachments....................................................................................... 6-30
ix
Transmitting a Case................................................................................................................. 6-31
Printing a Medical Summary......................................................................................................... 6-31
Deleting a Case................................................................................................................................ 6-32
Viewing Case Revisions................................................................................................................. 6-33
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
Filter Functions.................................................................................................................. 8-16
x