Oracle Argus Safety User's Guide - Oracle Documentation

430 Pages·2011·4.07 MB·English

Oracle® Argus Safety
User's Guide
Release 7.0
E20623-01
April 2011
Oracle Argus Safety User's Guide, Release 7.0
E20623-01
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Contents
Preface............................................................................................................................................................... xix
Documentation Accessibility................................................................................................................... xix
Related Documents................................................................................................................................... xx
Checking My Oracle Support.................................................................................................................. xx
Conventions............................................................................................................................................... xxi
1 Getting Started
Product Overview..................................................................................................................................... 1-1
Logging In and Out.................................................................................................................................. 1-1
Logging into the Argus Application............................................................................................... 1-1
About the Argus Home Page.................................................................................................................. 1-2
Additional Tabs........................................................................................................................................ 1-4
Quick Launch Toolbar...................................................................................................................... 1-4
Error Messages................................................................................................................................... 1-6
Searching for a Case........................................................................................................................... 1-6
Argus Insight Integration ................................................................................................................. 1-8
Sharing a Case Series......................................................................................................................... 1-8
Basic Features and User Actions...................................................................................................... 1-9
Sorting on Columns.................................................................................................................... 1-9
Configuring the Display View for a Case........................................................................ 1-9
Field Justifications............................................................................................................... 1-9
Getting Help............................................................................................................................. 1-10
Changing Your Password....................................................................................................... 1-11
Entering Dates.......................................................................................................................... 1-12
Using the Data Entry Abbreviation (DEA) to Enter Dates......................................... 1-13
Entering Multiple Language Text.......................................................................................... 1-14
Languages Supported in Argus Safety................................................................................. 1-14
2 Argus Affiliate Module
Argus Affiliate Module Information.................................................................................................... 2-1
3 Active Cases
Opening Active Cases............................................................................................................................. 3-1
v
4 Case Form
Case Form Functions................................................................................................................................ 4-1
Case Form Features............................................................................................................................ 4-2
Using Password Acceptance Dialog Boxes............................................................................. 4-2
Initial Case Entry......................................................................................................................... 4-3
Argus Safety Case Form User Preferences.............................................................................. 4-6
General Tab........................................................................................................................................ 4-6
General Usage Information....................................................................................................... 4-7
Dynamic Workflow Indicators.................................................................................................. 4-8
General Tab: General Information Section........................................................................... 4-8
General Information Fields................................................................................................ 4-8
General Tab: Study Information Section........................................................................... 4-10
Study Information Fields and Field Descriptions........................................................ 4-10
Study Restrictions............................................................................................................. 4-10
General Tab: Reporter Information..................................................................................... 4-11
Adding Reporter Information......................................................................................... 4-13
Reporter Lookup Dialog Box Fields............................................................................... 4-14
General Tab: Literature Information Section.................................................................... 4-15
Literature Information Fields and Field Descriptions................................................. 4-15
Patient Tab....................................................................................................................................... 4-16
Patient Tab: Patient Information.......................................................................................... 4-16
Patient Information Fields............................................................................................... 4-17
Neonate Information Section.......................................................................................... 4-18
Pregnancy Information.................................................................................................... 4-18
Entering Current Medical Status.................................................................................... 4-18
Copying Patient Information from Reporter Information.......................................... 4-19
Patient Details Section........................................................................................................... 4-19
Patient Details Fields and Field Descriptions............................................................... 4-19
Entering Pregnancy Information.................................................................................... 4-20
Event Death Details................................................................................................................. 4-21
Other Relevant History Section............................................................................................. 4-22
Other Relevant History Fields and Field Descriptions............................................... 4-22
Lab Data Section....................................................................................................................... 4-23
Lab Data Fields and Field Descriptions......................................................................... 4-24
Using the Lab Data Section............................................................................................. 4-24
Arranging the Lab Test data........................................................................................... 4-26
Relevant Tests Section.................................................................................................... 4-26
Patient Tab: Parent Information........................................................................................... 4-26
Parent Information Section.............................................................................................. 4-26
Other Relevant History Section...................................................................................... 4-27
Products Tab.................................................................................................................................... 4-29
General Usage Information.................................................................................................... 4-30
Time Measurement Fields............................................................................................... 4-30
Date of Mfr Field............................................................................................................... 4-30
Products Tab: Drug Tab.......................................................................................................... 4-31
Product Information Section.......................................................................................... 4-31
Product Indication Section.............................................................................................. 4-32
vi
QC Info............................................................................................................................... 4-32
Product Details Section.................................................................................................... 4-34
Dosage Regimens Section................................................................................................ 4-35
Study Drug Information................................................................................................. 4-37
Products Tab: Device Tab...................................................................................................... 4-37
Product Information Section........................................................................................ 4-37
Searching for Products..................................................................................................... 4-39
Entering Quality Control Information........................................................................... 4-42
Product Indication Section.............................................................................................. 4-43
Product Delivered by Device Section.......................................................................... 4-46
Product Delivered by Device Fields and Field Descriptions...................................... 4-46
Device Information Section........................................................................................... 4-46
Device Information Fields and Field Descriptions...................................................... 4-46
Products Tab: Vaccine Tab............................................................................................................. 4-48
Product Information Section................................................................................................. 4-49
Searching for Products..................................................................................................... 4-50
To perform a search in the Product Browser dialog box............................................ 4-50
WHO Drug Browser Search............................................................................................ 4-51
Entering Quality Control Information........................................................................... 4-52
Product Indication Section...................................................................................................... 4-53
Product Details Section.......................................................................................................... 4-54
Vaccine Information Section................................................................................................... 4-55
Entering Vaccine Administration Information............................................................. 4-56
Entering Prior Adverse Events Information................................................................. 4-57
Vaccine History Section......................................................................................................... 4-58
Events Tab........................................................................................................................................ 4-58
General Usage Information.................................................................................................... 4-59
Field Properties for Help Text/Default Labels............................................................ 4-61
Events Tab: Event Tab............................................................................................................. 4-62
Event Information Section............................................................................................... 4-62
Understanding the Diagnosis-Event Relationship...................................................... 4-64
Associating a symptom with a diagnosis.................................................................... 4-64
Using the MedDRA Browser.......................................................................................... 4-65
Configuring Regulatory Reporting Rules..................................................................... 4-65
Event Coding Section............................................................................................................. 4-65
Seriousness Criteria Section................................................................................................. 4-66
Entering Death Details..................................................................................................... 4-67
Entering Hospitalization Details.................................................................................... 4-67
Nature of Event Section................................................................................................... 4-68
Details Section.................................................................................................................. 4-69
Events Tab: Event Assessment Tab...................................................................................... 4-69
Filtering in the Event Assessment Tab.......................................................................... 4-70
User Actions on the Event Assessment Tab.................................................................. 4-70
Analysis Tab.................................................................................................................................... 4-71
Case Analysis Section............................................................................................................ 4-72
Using Auto Narrative Templates.......................................................................................... 4-72
Viewing Differences in Case Narratives....................................................................... 4-73
vii
Case Summary Section............................................................................................................ 4-73
Analysis Tab: MedWatch Info Tab....................................................................................... 4-75
Guidelines to Selecting G3 Report Source Check Boxes......................................... 4-76
Analysis Tab: BfArM Info Tab............................................................................................... 4-77
Analysis Tab: AFSSaPS Info Tab......................................................................................... 4-77
PMDA Tab........................................................................................................................................ 4-79
PMDA General Tab................................................................................................................. 4-79
General Tab: Keyword Search Product Assessment................................................... 4-79
Information Tab: Reason for the Research Report....................................................... 4-80
PMDA Tab: Field Label Rules, User Defined Fields, and Help ................................ 4-81
Activities Tab.................................................................................................................................. 4-82
Activities Tab: Contact Log Section....................................................................................... 4-82
Generating Letters............................................................................................................ 4-83
Scheduling Action Items for Letters.............................................................................. 4-85
Opening a Message Editor.............................................................................................. 4-85
Activities Tab: Action Items Section...................................................................................... 4-86
Action Items Fields and Field Descriptions.................................................................. 4-86
Activities Tab: Routing Comments Section....................................................................... 4-87
Routing Cases.................................................................................................................... 4-87
Returning Cases................................................................................................................ 4-88
Activities Tab: Case Lock/Close Section.............................................................................. 4-88
Locking a Case.................................................................................................................. 4-89
Unlocking a Case.............................................................................................................. 4-90
Setting the Focus for a Follow-up Event....................................................................... 4-90
Additional Information Tab......................................................................................................... 4-91
Additional Info Tab Fields and Field Descriptions............................................................. 4-92
Searching for Documentum Links......................................................................................... 4-93
Attaching Files to a Case......................................................................................................... 4-93
To attach files to a case..................................................................................................... 4-93
Entering Keywords.................................................................................................................. 4-93
Attaching References to a Case.............................................................................................. 4-93
Regulatory Reports Tab................................................................................................................. 4-93
General Usage Information.................................................................................................... 4-94
Regulatory Report Tab Fields and Field Descriptions....................................................... 4-94
Grouping Regulatory Reports................................................................................................ 4-96
Grouping by Report Type/Submit Category/Reporting Destination..................... 4-96
Grouping by Report Type/Reporting Destination...................................................... 4-96
Grouping by Report Type/Reporting Group............................................................... 4-96
5 Case Actions
Working with Cases................................................................................................................................. 5-1
Finding and Opening Existing Cases............................................................................................ 5-1
General Usage Information....................................................................................................... 5-2
Case Open Form Fields and Field Descriptions..................................................................... 5-2
Search Results Contents............................................................................................................. 5-3
Sharing a Case Series.................................................................................................................. 5-3
Processing a Case............................................................................................................................... 5-4
viii
Initial Case Entry Fields and Field Descriptions.................................................................... 5-4
Booking in Cases and Entering Initial Case Information...................................................... 5-6
Checking for Duplicates............................................................................................................. 5-8
Understanding Receipt Range Limits...................................................................................... 5-8
Closing a Case.................................................................................................................................... 5-9
Saving a Case................................................................................................................................... 5-10
Copying a Case................................................................................................................................ 5-10
Using the Medical Review Function.......................................................................................... 5-10
Common Actions..................................................................................................................... 5-11
Using the Medical Review Tab............................................................................................ 5-12
About the Case Narrative Section.................................................................................. 5-13
About the Case Assessment Section.............................................................................. 5-13
About the Event Assessment Section............................................................................. 5-13
Using Temporal View Tab...................................................................................................... 5-16
About the Summary Section........................................................................................... 5-16
About the Display Options Section................................................................................ 5-17
About the Event Assessment Section............................................................................. 5-17
About the Relevant Tests Section................................................................................... 5-18
Using the Action Items/Addl Info Tab....................................................................................... 5-19
About the Contact Log Section.............................................................................................. 5-19
Generating Letters............................................................................................................ 5-20
Scheduling Action Items for Letters.............................................................................. 5-21
Opening a Message Editor.............................................................................................. 5-21
About the Action Items Section............................................................................................. 5-22
About the Notes and Attachments Section.......................................................................... 5-23
Using the Coding Review Function............................................................................................. 5-23
General Information................................................................................................................ 5-23
Product Information................................................................................................................ 5-24
Event Information.................................................................................................................... 5-24
Death Information.................................................................................................................... 5-24
Patient Information.................................................................................................................. 5-25
Lab Data.................................................................................................................................... 5-26
Parent Information................................................................................................................... 5-26
Case Analysis............................................................................................................................ 5-27
Using the Action Item Tab............................................................................................................. 5-27
Action Item Fields and Field Descriptions........................................................................... 5-27
Using the Print Function............................................................................................................... 5-28
Accessing Print Medical Summary Functions..................................................................... 5-29
Printing a Case................................................................................................................................ 5-29
Printing a Case.......................................................................................................................... 5-30
Viewing and Printing Letters................................................................................................. 5-30
Viewing and Printing Attachments....................................................................................... 5-31
Transmitting a Case................................................................................................................. 5-31
Printing a Medical Summary......................................................................................................... 5-32
Deleting a Case............................................................................................................................... 5-33
Viewing Case Revisions............................................................................................................... 5-33
ix
6 Advanced Conditions
Advanced Conditions.............................................................................................................................. 6-1
About the Advanced Condition Screen.......................................................................................... 6-2
Filtering for Existing Advanced Conditions........................................................................... 6-3
Viewing Results from Existing Advanced Conditions.......................................................... 6-4
Working with Advanced Conditions.............................................................................................. 6-4
Creating, Viewing or Modifying Advanced Conditions....................................................... 6-4
About the Advanced Condition Set Dialog Box..................................................................... 6-5
Additional Information about Properties................................................................................ 6-5
Sharing Advanced Conditions.................................................................................................. 6-6
Using Advanced Conditions..................................................................................................... 6-7
Creating an Advanced Condition Query Set.......................................................................... 6-7
Renaming Query Sets.......................................................................................................... 6-8
Using the Hit List Tab................................................................................................................ 6-8
7 Worklist
About Worklist.......................................................................................................................................... 7-1
General Usage Information.............................................................................................................. 7-1
Worklist Filtering............................................................................................................................... 7-2
Worklist Options................................................................................................................................ 7-2
New and Open............................................................................................................................ 7-3
General Usage Information................................................................................................ 7-3
Search Case........................................................................................................................... 7-4
Filtering Functions............................................................................................................... 7-4
Total Number of Rows........................................................................................................ 7-5
Routing Details..................................................................................................................... 7-7
Workflow Options............................................................................................................................ 7-7
Worklist User Options................................................................................................................ 7-7
Worklist Action Items....................................................................................................................... 7-9
General Usage Information.................................................................................................... 7-10
Query Management................................................................................................................. 7-10
Query Action Items.................................................................................................................. 7-11
Search Case............................................................................................................................... 7-12
Filter Function.......................................................................................................................... 7-13
Total Number of Rows..................................................................................................... 7-13
Coding Action Items....................................................................................................................... 7-14
Search Case............................................................................................................................... 7-15
Filter Functions......................................................................................................................... 7-15
Total Number of Rows............................................................................................................ 7-15
Contacts............................................................................................................................................ 7-16
Search Case............................................................................................................................... 7-17
Filter Functions.................................................................................................................. 7-17
Total Number of Rows..................................................................................................... 7-18
Reports.............................................................................................................................................. 7-18
Search Case............................................................................................................................... 7-19
Filter Function.......................................................................................................................... 7-20
General Usage Information............................................................................................. 7-20
x