Oracle Argus Safety English User's Guide Release 7.0.3

390 Pages·2013·8.56 MB·English

by  Oracle Corporation

Oracle Argus Safety
English User's Guide
Release 7.0.3
E40566-01
July 2013
Oracle Argus Safety English User's Guide Release 7.0.3
E40566-01
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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................................................................................................................................... 1-5
Searching for a Case........................................................................................................................... 1-5
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............................................................................................................... 1-8
Getting Help................................................................................................................................ 1-9
Changing Your Password....................................................................................................... 1-10
Entering Dates.......................................................................................................................... 1-11
Entering Multiple Language Text.......................................................................................... 1-11
Languages Supported in Argus Safety................................................................................. 1-11
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......................................................................................................................... 4-2
Argus Safety Case Form User Preferences.............................................................................. 4-6
General Tab......................................................................................................................................... 4-6
General Usage Information....................................................................................................... 4-7
Dynamic Workflow Indicators.................................................................................................. 4-7
General Tab: General Information Section.............................................................................. 4-8
General Information Fields................................................................................................ 4-8
General Tab: Study Information Section................................................................................. 4-9
Study Information Fields and Field Descriptions........................................................... 4-9
Study Restrictions............................................................................................................. 4-10
General Tab: Reporter Information....................................................................................... 4-11
Adding Reporter Information......................................................................................... 4-13
Reporter Lookup Dialog Box Fields............................................................................... 4-14
Reporter Information....................................................................................................... 4-14
General Tab: Literature Information Section....................................................................... 4-16
Literature Information Fields and Field Descriptions................................................. 4-16
Patient Tab........................................................................................................................................ 4-17
Patient Tab: Patient Information............................................................................................ 4-17
Patient Information Fields............................................................................................... 4-18
Neonate Information Section.......................................................................................... 4-19
Pregnancy Information.................................................................................................... 4-19
Entering Current Medical Status.................................................................................... 4-19
Copying Patient Information from Reporter Information.......................................... 4-20
Patient Details Section............................................................................................................. 4-20
Patient Details Fields and Field Descriptions............................................................... 4-20
Entering Pregnancy Information.................................................................................... 4-21
Event Death Details................................................................................................................. 4-22
Other Relevant History Section............................................................................................. 4-23
Other Relevant History Fields and Field Descriptions............................................... 4-23
Lab Data Section....................................................................................................................... 4-24
Lab Data Fields and Field Descriptions......................................................................... 4-24
Using the Lab Data Section............................................................................................. 4-25
Arranging the Lab Test data........................................................................................... 4-26
Relevant Tests Section...................................................................................................... 4-26
Patient Tab: Parent Information............................................................................................. 4-27
Parent Information Section.............................................................................................. 4-27
Other Relevant History Section...................................................................................... 4-28
Products Tab.................................................................................................................................... 4-29
General Usage Information.................................................................................................... 4-30
Time Measurement Fields............................................................................................... 4-30
Date of Mfr Field............................................................................................................... 4-31
Products Tab: Drug Tab.......................................................................................................... 4-31
Product Information Section.......................................................................................... 4-31
vi
Product Indication Section.............................................................................................. 4-32
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........................................................................... 4-41
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.......................................................................................... 4-48
Searching for Products..................................................................................................... 4-50
To perform a search in the Product Browser dialog box............................................ 4-50
WHO Drug Browser Search............................................................................................ 4-50
Entering Quality Control Information........................................................................... 4-52
Product Indication Section.............................................................................................. 4-53
Product Details Section.................................................................................................... 4-54
Vaccine Information Section........................................................................................... 4-54
Entering Vaccine Administration Information............................................................. 4-56
Entering Prior Adverse Events Information................................................................. 4-57
Vaccine History Section................................................................................................... 4-57
Events Tab........................................................................................................................................ 4-58
General Usage Information.................................................................................................... 4-58
Field Properties for Help Text/Default Labels............................................................ 4-60
Events Tab: Event Tab............................................................................................................. 4-61
Event Information Section............................................................................................... 4-62
Understanding the Diagnosis-Event Relationship...................................................... 4-63
Associating a symptom with a diagnosis...................................................................... 4-63
Using the MedDRA Browser.......................................................................................... 4-64
Configuring Regulatory Reporting Rules..................................................................... 4-64
Event Coding Section.............................................................................................................. 4-65
Seriousness Criteria Section................................................................................................... 4-65
Entering Death Details..................................................................................................... 4-66
Entering Hospitalization Details.................................................................................... 4-67
Nature of Event Section................................................................................................... 4-67
Details Section................................................................................................................... 4-68
Events Tab: Event Assessment Tab....................................................................................... 4-68
Filtering in the Event Assessment Tab.......................................................................... 4-69
User Actions on the Event Assessment Tab.................................................................. 4-69
Analysis Tab..................................................................................................................................... 4-70
Case Analysis Section.............................................................................................................. 4-70
Using Auto Narrative Templates.......................................................................................... 4-71
vii
Viewing Differences in Case Narratives....................................................................... 4-72
Case Summary Section............................................................................................................ 4-72
Analysis Tab: MedWatch Info Tab........................................................................................ 4-73
Guidelines to Selecting G3 Report Source Checkboxes.............................................. 4-75
Analysis Tab: BfArM Info Tab............................................................................................... 4-75
Analysis Tab: AFSSaPS Info Tab............................................................................................ 4-76
Activities Tab................................................................................................................................... 4-77
Activities Tab: Contact Log Section....................................................................................... 4-77
Generating Letters............................................................................................................ 4-78
Scheduling Action Items for Letters.............................................................................. 4-81
Opening a Message Editor.............................................................................................. 4-81
Activities Tab: Action Items Section...................................................................................... 4-81
Action Items Fields and Field Descriptions.................................................................. 4-81
Activities Tab: Routing Comments Section.......................................................................... 4-82
Routing Cases.................................................................................................................... 4-82
Returning Cases................................................................................................................ 4-83
Activities Tab: Case Lock/Close Section.............................................................................. 4-83
Locking a Case.................................................................................................................. 4-84
Unlocking a Case.............................................................................................................. 4-85
Setting the Focus for a Follow-up Event....................................................................... 4-85
Additional Information Tab.......................................................................................................... 4-86
Additional Info Tab Fields and Field Descriptions............................................................. 4-87
Searching for Documentum Links......................................................................................... 4-88
Attaching Files to a Case......................................................................................................... 4-89
To attach files to a case..................................................................................................... 4-89
Entering Keywords.................................................................................................................. 4-89
Attaching References to a Case.............................................................................................. 4-89
Regulatory Reports Tab.................................................................................................................. 4-89
General Usage Information.................................................................................................... 4-90
Regulatory Report Tab Fields and Field Descriptions....................................................... 4-90
Grouping Regulatory Reports................................................................................................ 4-91
Grouping by Report Type/Submit Category/Reporting Destination..................... 4-92
Grouping by Report Type/Reporting Destination...................................................... 4-92
Grouping by Report Type/Reporting Group............................................................... 4-92
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
Initial Case Entry Fields and Field Descriptions.................................................................... 5-5
Booking in Cases and Entering Initial Case Information...................................................... 5-6
Checking for Duplicates............................................................................................................. 5-9
Understanding Receipt Range Limits...................................................................................... 5-9
viii
Closing a Case..................................................................................................................................... 5-9
Saving a Case................................................................................................................................... 5-10
Copying a Case................................................................................................................................ 5-10
Using the Medical Review Function............................................................................................ 5-11
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...................................................................................................... 5-15
About the Summary Section........................................................................................... 5-16
About the Display Options Section................................................................................ 5-16
About the Event Assessment Section............................................................................. 5-17
About the Relevant Tests Section................................................................................... 5-18
Using the Action Items/Additional Info Tab...................................................................... 5-18
About the Contact Log Section....................................................................................... 5-18
Generating Letters............................................................................................................ 5-19
Scheduling Action Items for Letters.............................................................................. 5-20
Opening a Message Editor.............................................................................................. 5-20
About the Action Items Section...................................................................................... 5-21
About the Notes and Attachments Section................................................................... 5-21
Using the Coding Review Function............................................................................................. 5-22
General Information................................................................................................................ 5-22
Product Information................................................................................................................ 5-23
Event Information.................................................................................................................... 5-23
Death Information.................................................................................................................... 5-23
Patient Information.................................................................................................................. 5-24
Lab Data.................................................................................................................................... 5-24
Parent Information................................................................................................................... 5-24
Case Analysis............................................................................................................................ 5-25
Common Buttons Available in Coding Review.................................................................. 5-25
Using the Action Item Tab............................................................................................................. 5-26
Action Item Fields and Field Descriptions........................................................................... 5-26
Using the Print Function................................................................................................................ 5-27
Accessing Print Medical Summary Functions..................................................................... 5-27
Printing a Case................................................................................................................................. 5-28
Printing a Case.......................................................................................................................... 5-28
Viewing and Printing Letters................................................................................................. 5-29
Viewing and Printing Attachments....................................................................................... 5-29
Transmitting a Case................................................................................................................. 5-30
Printing a Medical Summary......................................................................................................... 5-30
Deleting a Case................................................................................................................................ 5-31
Viewing Case Revisions................................................................................................................. 5-32
6 Advanced Conditions
Advanced Conditions.............................................................................................................................. 6-1
About the Advanced Condition Screen.......................................................................................... 6-2
ix
Filtering for Existing Advanced Conditions........................................................................... 6-3
Viewing Results from Existing Advanced Conditions.......................................................... 6-4
Working with Advanced Conditions.............................................................................................. 6-5
Creating, Viewing or Modifying Advanced Conditions....................................................... 6-5
About the Advanced Condition Set Dialog Box..................................................................... 6-5
Additional Information about Properties................................................................................ 6-6
Sharing Advanced Conditions.................................................................................................. 6-8
Using Advanced Conditions..................................................................................................... 6-8
Creating an Advanced Condition Query Set.......................................................................... 6-9
Renaming Query Sets.......................................................................................................... 6-9
Using the Hit List Tab............................................................................................................. 6-10
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........................................................................................................................... 7-3
Filtering Functions............................................................................................................... 7-4
Total Number of Rows........................................................................................................ 7-4
Routing Details..................................................................................................................... 7-6
Workflow Options............................................................................................................................. 7-6
Worklist User Options................................................................................................................ 7-7
Worklist Action Items........................................................................................................................ 7-9
General Usage Information....................................................................................................... 7-9
Query Management.................................................................................................................... 7-9
Query Action Items.................................................................................................................. 7-10
Search Case............................................................................................................................... 7-11
Filter Function.......................................................................................................................... 7-11
Total Number of Rows..................................................................................................... 7-12
Coding Action Items....................................................................................................................... 7-13
Search Case............................................................................................................................... 7-13
Filter Functions......................................................................................................................... 7-13
Total Number of Rows............................................................................................................ 7-14
Contacts............................................................................................................................................ 7-15
Search Case............................................................................................................................... 7-15
Filter Functions.................................................................................................................. 7-15
Total Number of Rows..................................................................................................... 7-15
Reports.............................................................................................................................................. 7-16
Search Case............................................................................................................................... 7-16
Filter Function.......................................................................................................................... 7-17
General Usage Information............................................................................................. 7-17
Filtering Reports by Report Destination....................................................................... 7-18
Filtering Reports by Product Family.............................................................................. 7-18
Filtering Reports by Country of Incidence.................................................................... 7-18
x