Table Of Content

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 Copyright © 2009, 2011 Oracle and/or its affiliates. All rights reserved. This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited. The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing. If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, the following notice is applicable: U.S. GOVERNMENT RIGHTS Programs, software, databases, and related documentation and technical data delivered to U.S. Government customers are "commercial computer software" or "commercial technical data" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, the use, duplication, disclosure, modification, and adaptation shall be subject to the restrictions and license terms set forth in the applicable Government contract, and, to the extent applicable by the terms of the Government contract, the additional rights set forth in FAR 52.227-19, Commercial Computer Software License (December 2007). Oracle USA, Inc., 500 Oracle Parkway, Redwood City, CA 94065. This software is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications which may create a risk of personal injury. If you use this software in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure the safe use of this software. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software in dangerous applications. Oracle is a registered trademark of Oracle Corporation and/or its affiliates. Other names may be trademarks of their respective owners. This software and documentation may provide access to or information on content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services. 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

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