Oracle® Argus Safety

394 Pages·2011·4.07 MB·English

Oracle® Argus Safety
User's Guide
Release 6.0.1
E15952-03
July 2011
Oracle Argus Safety User's Guide, Release 6.0.1
E15952-03
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Contents
Preface............................................................................................................................................................... xiii
1 Product Overview
Application Map....................................................................................................................................... 1-1
2 Getting Started
Logging In and Out.................................................................................................................................. 2-1
Logging into the Argus Application............................................................................................... 2-1
About the Argus Home Page.................................................................................................................. 2-3
Additional Tabs........................................................................................................................................ 2-4
Quick Launch Toolbar...................................................................................................................... 2-4
Error Messages................................................................................................................................... 2-6
Searching for a Case........................................................................................................................... 2-6
Sharing a Case Series......................................................................................................................... 2-8
Basic Features and User Actions...................................................................................................... 2-8
Sorting on Columns.................................................................................................................... 2-9
Getting Help............................................................................................................................. 2-10
Changing Your Password....................................................................................................... 2-11
Entering Dates.......................................................................................................................... 2-12
Entering Multiple Language Text.......................................................................................... 2-13
Languages Supported in Argus Safety................................................................................. 2-13
3 Active Cases
Opening Active Cases............................................................................................................................. 3-1
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
v
General Tab: General Information Section........................................................................... 4-8
General Tab: Study Information Section........................................................................... 4-10
General Tab: Reporter Information..................................................................................... 4-11
General Tab: Literature Information Section.................................................................... 4-15
Patient Tab....................................................................................................................................... 4-16
Patient Tab: Patient Information.......................................................................................... 4-16
Patient Details Section........................................................................................................... 4-18
Event Death Details................................................................................................................. 4-20
Other Relevant History Section............................................................................................. 4-21
Lab Data Section....................................................................................................................... 4-23
Patient Tab: Parent Information........................................................................................... 4-25
Products Tab.................................................................................................................................... 4-27
General Usage Information.................................................................................................... 4-28
Products Tab: Drug Tab.......................................................................................................... 4-29
Products Tab: Device Tab...................................................................................................... 4-35
Products Tab: Vaccine Tab............................................................................................................. 4-46
Product Information Section................................................................................................. 4-46
Product Indication Section...................................................................................................... 4-51
Product Details Section.......................................................................................................... 4-52
Vaccine Information Section................................................................................................... 4-52
Vaccine History Section......................................................................................................... 4-55
Events Tab........................................................................................................................................ 4-56
General Usage Information.................................................................................................... 4-56
Events Tab: Event Tab............................................................................................................. 4-59
Event Coding Section............................................................................................................. 4-63
Seriousness Criteria Section................................................................................................. 4-63
Events Tab: Event Assessment Tab...................................................................................... 4-66
Events Tab: Product -- Event Details Tab............................................................................. 4-67
Analysis Tab.................................................................................................................................... 4-69
Case Analysis Section............................................................................................................ 4-70
Using Auto Narrative Templates.......................................................................................... 4-71
Case Summary Section............................................................................................................ 4-72
Analysis Tab: MedWatch Info Tab....................................................................................... 4-73
Analysis Tab: BfArM Info Tab............................................................................................... 4-75
Analysis Tab: AFSSaPS Info Tab......................................................................................... 4-75
Activities Tab.................................................................................................................................. 4-77
Activities Tab: Contact Log Section....................................................................................... 4-77
Activities Tab: Action Items Section...................................................................................... 4-81
Activities Tab: Routing Comments Section....................................................................... 4-82
Activities Tab: Case Lock/Close Section.............................................................................. 4-83
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......................................................................................................... 4-88
Entering Keywords.................................................................................................................. 4-88
Attaching References to a Case.............................................................................................. 4-88
Regulatory Reports Tab................................................................................................................. 4-88
vi
General Usage Information.................................................................................................... 4-89
Regulatory Report Tab Fields and Field Descriptions....................................................... 4-89
Grouping Regulatory Reports................................................................................................ 4-91
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.................................................................... 5-4
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
Using Temporal View Tab...................................................................................................... 5-15
Using the Action Items/Addl Info Tab....................................................................................... 5-18
About the Contact Log Section.............................................................................................. 5-19
About the Action Items Section............................................................................................. 5-21
About the Notes and Attachments Section.......................................................................... 5-22
Using the Coding Review Function............................................................................................. 5-22
General Information................................................................................................................ 5-23
Product Information................................................................................................................ 5-23
Event Information.................................................................................................................... 5-23
Death Information.................................................................................................................... 5-24
Patient Information.................................................................................................................. 5-24
Lab Data.................................................................................................................................... 5-25
Parent Information................................................................................................................... 5-25
Case Analysis............................................................................................................................ 5-26
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..................................................................... 5-28
Printing a Case................................................................................................................................ 5-28
Printing a Case.......................................................................................................................... 5-29
Viewing and Printing Letters................................................................................................. 5-30
Viewing and Printing Attachments....................................................................................... 5-30
Transmitting a Case................................................................................................................. 5-30
Printing a Medical Summary......................................................................................................... 5-31
Deleting a Case............................................................................................................................... 5-32
vii
Viewing Case Revisions............................................................................................................... 5-32
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..................................................................................................... 6-6
Creating an Advanced Condition Query Set.......................................................................... 6-7
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
Workflow Options............................................................................................................................ 7-8
Worklist User Options................................................................................................................ 7-8
Worklist Action Items.................................................................................................................... 7-10
General Usage Information.................................................................................................... 7-10
Query Management................................................................................................................. 7-10
Query Action Item Example................................................................................................... 7-11
Search Case............................................................................................................................... 7-12
Filter Function.......................................................................................................................... 7-12
Coding Action Items....................................................................................................................... 7-14
Search Case............................................................................................................................... 7-14
Filter Functions......................................................................................................................... 7-15
Total Number of Rows............................................................................................................ 7-15
Contacts............................................................................................................................................ 7-16
Search Case............................................................................................................................... 7-16
Reports.............................................................................................................................................. 7-18
Search Case............................................................................................................................... 7-18
Filter Function.......................................................................................................................... 7-19
Total Number of Rows............................................................................................................ 7-21
Bulk Transmit.................................................................................................................................. 7-23
To view the Bulk Transmit page............................................................................................ 7-23
General Usage Information.................................................................................................... 7-24
Bulk Print.......................................................................................................................................... 7-26
General Usage Information.................................................................................................... 7-26
Bulk E2B Transmit.......................................................................................................................... 7-28
General Usage Information.................................................................................................... 7-29
viii
Local Labeling.................................................................................................................................. 7-34
Coding Status................................................................................................................................... 7-36
Search Conditions Section...................................................................................................... 7-36
Total Number of Rows Section.............................................................................................. 7-37
Coding Status Icons................................................................................................................. 7-38
Letters............................................................................................................................................... 7-38
Search Case Section.................................................................................................................. 7-39
Total Number of Rows Section.............................................................................................. 7-39
8 MedDRA Browser
MedDRA Browser Functionality........................................................................................................... 8-1
Using the MedDRA Browser............................................................................................................ 8-2
MedDRA Browser Dialog Fields and Field Descriptions..................................................... 8-2
MedDRA Searches and Search Results.................................................................................... 8-2
MedDRA Recoding............................................................................................................................ 8-3
MedDRA Recoding Logic.......................................................................................................... 8-4
9 Argus Affiliate Module
Argus Affiliate Module Information.................................................................................................... 9-1
10 Argus Reports
Reports..................................................................................................................................................... 10-1
Compliance Reports........................................................................................................................ 10-2
About Expedited Reports...................................................................................................... 10-2
About Periodic Reports........................................................................................................ 10-16
Submitted Reports......................................................................................................................... 10-23
Submitting Reports................................................................................................................ 10-23
Submitted Reports Search Results....................................................................................... 10-24
Unsubmitting Reports........................................................................................................... 10-25
Lock State Header Options................................................................................................... 10-25
Aggregate Reports........................................................................................................................ 10-26
General Usage Information.................................................................................................. 10-26
Using the System Reports Library....................................................................................... 10-27
About Case Data Analysis Reports............................................................................................ 10-31
Creating a Case Data Analysis Report................................................................................ 10-32
Memorizing the Criteria Specified for a Particular Report.............................................. 10-32
Saving, Deleting, or Cancelling a Report............................................................................ 10-32
About CIOMS II Line Listing Reports.................................................................................... 10-33
Creating a CIOMS II Line Listing Report........................................................................... 10-33
About Case Listing Reports....................................................................................................... 10-34
About System (Memorized) Reports........................................................................................ 10-35
General Usage Information.................................................................................................. 10-36
Periodic Report Types................................................................................................................. 10-36
Storing Periodic Reports in Documentum......................................................................... 10-36
Viewing a Summary of Periodic Regulatory Reports...................................................... 10-36
Using the Library Page.......................................................................................................... 10-37
ix
About Clinical Trial Periodic Reports........................................................................................ 10-39
General Usage Information.................................................................................................. 10-40
Common Tab Fields............................................................................................................... 10-42
ICH PSUR Reports....................................................................................................................... 10-63
General Usage Information.................................................................................................. 10-64
CIOMS Reports.............................................................................................................................. 10-78
Cumulative Summary........................................................................................................... 10-79
FDA PSUR Support............................................................................................................... 10-79
Single Case Submission Support......................................................................................... 10-81
UD Summaries Tab................................................................................................................ 10-81
Scheduling Tab....................................................................................................................... 10-82
Security Tab............................................................................................................................ 10-84
US IND Periodic Reports............................................................................................................ 10-85
Common Fields...................................................................................................................... 10-86
US NDA Periodic Reports............................................................................................................ 10-94
General Usage Information.................................................................................................. 10-95
Common Fields...................................................................................................................... 10-96
Subject of Report Tab............................................................................................................. 10-97
Product Selection Tab............................................................................................................ 10-98
Inclusion Criteria Tab.......................................................................................................... 10-100
Line Listing Tab.................................................................................................................... 10-101
Summary Tabulations Tab.................................................................................................. 10-103
Scheduling Tab..................................................................................................................... 10-104
Security Tab.......................................................................................................................... 10-105
Bulk Reporting........................................................................................................................... 10-106
Bulk Reporting Filter Section............................................................................................. 10-107
Total Number of Rows Section.......................................................................................... 10-108
Printing Options................................................................................................................... 10-109
User Options......................................................................................................................... 10-110
Incoming E2B Reports............................................................................................................... 10-110
Incoming E2B Reports Fields............................................................................................. 10-111
Pending Reports................................................................................................................... 10-113
Bulk Incoming E2B Reports..................................................................................................... 10-113
Duplicate Search........................................................................................................................ 10-114
Duplicate Search Dialog Box Fields and Field Descriptions......................................... 10-114
Duplicate Search for Incoming Review.......................................................................... 10-116
View Differences Report............................................................................................................ 10-117
Displaying Differences........................................................................................................ 10-118
Processed E2B Reports............................................................................................................... 10-118
Search Criteria Section........................................................................................................ 10-119
Total Number of Rows Section.......................................................................................... 10-119
11 Dashboards
Dashboards Options............................................................................................................................. 11-1
Open Case Summary Reports...................................................................................................... 11-1
Open Action Items Reports.......................................................................................................... 11-3
Quick Signal Report...................................................................................................................... 11-3
x