Oracle® Argus Safety Administrator’s Guide Release 8.1 E68427-01 September 2016 Oracle Argus Safety Administrator’s Guide Release 8.1 E68427-01 Copyright © 2016 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. 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Contents Preface............................................................................................................................................................... viii Intended Audience.................................................................................................................................... viii The Oracle Health Sciences Safety Suite................................................................................................ viii Documentation Accessibility..................................................................................................................... ix Related Documents..................................................................................................................................... ix Conventions................................................................................................................................................. x 1 Introduction Introduction............................................................................................................................................... 1-1 Argus Safety Configuration Process Overview.......................................................................... 1-1 Usage Conventions........................................................................................................................... 1-2 Getting Started................................................................................................................................... 1-2 Argus Console Architecture............................................................................................................ 1-3 Required Fields.......................................................................................................................... 1-3 Standard Buttons........................................................................................................................ 1-3 Standard Icons............................................................................................................................ 1-4 Administrator Login......................................................................................................................... 1-5 Logging In as an Administrator:............................................................................................. 1-5 Changing the Administrator’s Password.............................................................................. 1-6 Logging out................................................................................................................................. 1-6 Accessing the Home Page......................................................................................................... 1-6 Launching Online Help............................................................................................................ 1-6 Understanding Argus Console GUI....................................................................................... 1-6 2 Access Management Access Management................................................................................................................................. 2-1 Configuring User Sites..................................................................................................................... 2-1 Field Descriptions...................................................................................................................... 2-1 Adding User Sites...................................................................................................................... 2-2 Configuring Groups......................................................................................................................... 2-5 Field Descriptions...................................................................................................................... 2-5 Adding User Groups................................................................................................................. 2-7 Printing a User Group............................................................................................................ 2-11 Configuring Users.......................................................................................................................... 2-13 Field Descriptions................................................................................................................... 2-13 iii Printing Users.......................................................................................................................... 2-16 3 Business Configuration About Business Configuration.............................................................................................................. 3-1 Editable and Non-editable Business Configuration Sections.................................................. 3-1 Type Ahead Fields..................................................................................................................... 3-3 Additional Comments Fields................................................................................................... 3-3 Configuring Product Family........................................................................................................... 3-3 Field Descriptions...................................................................................................................... 3-4 Adding Product Families.......................................................................................................... 3-4 Creating Data Sheets................................................................................................................. 3-6 Field Descriptions...................................................................................................................... 3-6 Configuring Products....................................................................................................................... 3-9 Field Descriptions................................................................................................................... 3-10 Adding Products..................................................................................................................... 3-11 Configuring Licenses.................................................................................................................... 3-13 Field Descriptions................................................................................................................... 3-13 Adding Product Licenses....................................................................................................... 3-15 Using the Product Browser................................................................................................... 3-17 Configuring Clinical Studies....................................................................................................... 3-18 Field Descriptions................................................................................................................... 3-18 Adding Clinical Study Configurations.............................................................................. 3-21 Adding WHO Drug Details.................................................................................................. 3-23 Adding Product Details......................................................................................................... 3-24 Configuring Auto Encoding................................................................................................. 3-26 Configuring Study Reporting.............................................................................................. 3-27 Configuring Expedited Report Rules......................................................................................... 3-28 Field Descriptions................................................................................................................... 3-30 Adding Expedited Report Rules.......................................................................................... 3-34 4 System Configuration System Configuration Overview........................................................................................................... 4-1 Configuring Case Priority............................................................................................................... 4-2 Field Descriptions...................................................................................................................... 4-2 Configuring Field Validations........................................................................................................ 4-4 Field Descriptions...................................................................................................................... 4-5 Modifying Field Validations................................................................................................... 4-5 Configuring LAM System Numbering......................................................................................... 4-6 Field Descriptions...................................................................................................................... 4-6 Configuring System Management - Common Profile Switches.............................................. 4-9 Configuring Advanced Conditions..................................................................................... 4-11 Configuring Case Form (System Management)................................................................ 4-12 SMTP Configuration.............................................................................................................. 4-20 Configuring Case Processing................................................................................................ 4-21 Configuring Assessments..................................................................................................... 4-25 Configuring Auto Archiving................................................................................................ 4-26 iv Configuring Case Numbering.............................................................................................. 4-28 Configuring Lot Number...................................................................................................... 4-29 Configuring Dictionary Browser......................................................................................... 4-32 Configuring WHO Drug........................................................................................................ 4-33 Configuring Performance...................................................................................................... 4-33 Configuring Documentum.................................................................................................... 4-35 Local Labeling......................................................................................................................... 4-39 User Interface........................................................................................................................... 4-42 Configuring Reporting.......................................................................................................... 4-43 Configuring Security.............................................................................................................. 4-62 Configuring Single Sign-on.................................................................................................. 4-65 Error Messages......................................................................................................................... 4-67 Configuring SMTP................................................................................................................. 4-67 Configuring Workflow Items............................................................................................... 4-68 Configuring Workflow.................................................................................................................. 4-71 Worklist Updates..................................................................................................................... 4-71 Configuring Case Workflow................................................................................................. 4-72 Worklist Intake........................................................................................................................ 4-76 Configuring System Numbering................................................................................................ 4-83 Field Descriptions................................................................................................................... 4-83 Configuring Field Properties....................................................................................................... 4-85 Field Descriptions................................................................................................................... 4-86 Adding User Defined Fields.......................................................................................................... 4-87 Configuring User Defined Fields............................................................................................... 4-88 5 Code List Configuration Configuring Code Lists > Argus........................................................................................................... 5-1 Configuring Autosignals................................................................................................................. 5-2 Field Descriptions...................................................................................................................... 5-2 Configuring Batch Reports.............................................................................................................. 5-4 Field Descriptions...................................................................................................................... 5-4 Configuring Letters........................................................................................................................... 5-6 Field Descriptions...................................................................................................................... 5-7 Configuring Justifications............................................................................................................... 5-9 Field Descriptions...................................................................................................................... 5-9 Configuring Electronic Transmission........................................................................................ 5-10 Field Descriptions................................................................................................................... 5-11 Configuring Event Groups........................................................................................................... 5-12 Terms tab................................................................................................................................... 5-12 Event Groups tab.................................................................................................................... 5-14 SMQ tab.................................................................................................................................... 5-14 Configuring Literary Citations.................................................................................................... 5-16 Field Descriptions................................................................................................................... 5-17 Configuring Message Type.......................................................................................................... 5-18 Field Descriptions................................................................................................................... 5-19 Configuring Reporting Destination........................................................................................... 5-20 Agency Information............................................................................................................... 5-20 v Local Company Contact......................................................................................................... 5-24 Configuring EDI..................................................................................................................... 5-26 Configuring the Base Directory Path.................................................................................... 5-30 SMTP......................................................................................................................................... 5-30 Configuring Routes of Administration..................................................................................... 5-32 Field Descriptions................................................................................................................... 5-33 Configuring Study Center............................................................................................................ 5-34 Field Descriptions................................................................................................................... 5-34 Configuring Holiday Calendar................................................................................................... 5-35 Field Descriptions................................................................................................................... 5-36 Other Code List Items................................................................................................................... 5-37 Formulation Factory Data...................................................................................................... 5-43 Configuring Code Lists > Flexible Data Re-Categorization......................................................... 5-44 Flexible Code Lists.......................................................................................................................... 5-45 Flexible Re-Categorization............................................................................................................. 5-46 6 Accessing Tools Accessing Tools......................................................................................................................................... 6-1 Report Features.................................................................................................................................. 6-1 Viewing the E2B Length Check Report........................................................................................ 6-1 7 Using Advanced Conditions Using Advanced Conditions.................................................................................................................. 7-1 Features within Advanced Conditions......................................................................................... 7-2 Using Advanced Conditions........................................................................................................... 7-3 Creating Advanced Conditions...................................................................................................... 7-3 Creating a Query Set of Advanced Conditions........................................................................... 7-6 New Action Type Fields and Field Description................................................................... 7-6 The Hit List Tab................................................................................................................................. 7-9 8 Best Practices Configuring Argus Safety for ICSR Reports (HL7)........................................................................... 8-1 Configuring Reporting Destination for HL7 ICSR Reports......................................................... 8-1 Customizing Profiles......................................................................................................................... 8-3 Configuring ICSR Validation using the New Framework........................................................... 8-3 Configuring Codelists....................................................................................................................... 8-4 eMDR Specific Codelist Updates.............................................................................................. 8-4 eVAERS Specific Codelist Updates.......................................................................................... 8-4 PMDA E2B (R3) Flex Codelist.......................................................................................................... 8-5 Business Configuration Updates..................................................................................................... 8-6 Setting up the Application Type in Business Configuration -> Products and Licenses (eVAERS specific) 8-6 Configuring PMDA Specific License Parameters.................................................................. 8-6 Configuring PMDA E2B (R3) Specific Study Parameter....................................................... 8-6 System Configuration Updates........................................................................................................ 8-6 ..........................................................................................PMDA E2B (R3) Specific Switches 8-6 vi Optional Upgrade Scripts for Data Migration to New Fields..................................................... 8-7 eVAERS specific.......................................................................................................................... 8-7 eMDR Specific............................................................................................................................. 8-8 Importing E2B (R3) Reports.............................................................................................................. 8-9 Attachments in HL7 Reports............................................................................................................... 8-10 Creating and Managing Amendments for eVAERS and E2B (R3) report.................................. 8-10 Null Flavor Handling in HL7 Reports............................................................................................... 8-11 Best Practices in a Multi-Tenant Environment................................................................................ 8-11 Single Sign-on................................................................................................................................ 8-12 Accessing Argus Safety Directly via URL.......................................................................... 8-12 Global Homepage and Portlets................................................................................................... 8-12 Global Worklists Columns.................................................................................................... 8-12 Global User Management..................................................................................................... 8-12 User-Enterprise Association.................................................................................................. 8-12 New User Creation/Association........................................................................................... 8-13 Inactivating an Enterprise..................................................................................................... 8-13 New Enterprise Setup................................................................................................................... 8-13 Segregated by Enterprise.............................................................................................................. 8-13 Maintaining Consistency Across Enterprises................................................................... 8-13 Shared Across Enterprises............................................................................................................ 8-14 Pre-upgrade Considerations for Existing Databases............................................................... 8-14 Post-upgrade Considerations for Existing Databases............................................................. 8-14 Documentum Migration............................................................................................................... 8-15 vii Preface This document describes the steps for installing and configuring the components of the Argus Safety Solution application. Intended Audience This document is intended for administrators of the Argus Safety system for configuring Argus Safety. The Oracle Health Sciences Safety Suite This product is part of the Oracle Health Sciences Safety Suite, an integrated solution for end-to-end vigilance from adverse event management to signal management, through the entire lifecycle of a medicinal product from clinical trials to post-marketing surveillance. The Oracle Health Sciences Safety Suite consists of the following components: ■ Oracle Argus Standard Edition: Manage and report adverse events through a workflow including case intake, data entry, coding, quality review, medical review, expedited reporting, and periodic reporting. Modules include Oracle Argus Safety, Oracle Argus Interchange, Oracle Argus Affiliate, Oracle Argus Dossier, Oracle Argus Unblinding, and the Oracle Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus. viii ■ Oracle Argus Enterprise Edition: In addition to managing the adverse event workflow and reporting, employ a powerful and flexible business analytics and intelligence platform for both scientific analysis and operational metrics. Modules include Oracle Argus Analytics, Oracle Argus Insight, Oracle Argus Mart, Oracle Argus Safety, Oracle Argus Interchange, Oracle Argus Affiliate, Oracle Argus Dossier, Oracle Argus Unblinding, and the Oracle Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus. ■ Oracle Argus Safety Japan: Manage and report adverse events in Japan, and connect the global and local workflows using a single database. ■ Oracle Health Sciences Empirica Topics: Manage and document safety signals through a workflow including validation, prioritization, assessment, confirmation/refutation, and resulting actions. ■ Oracle Health Sciences Empirica Study: Detect and analyze safety signals in clinical trial data including adverse events, clinically significant labs, electrocardiograms, vital signs, and shifts from baseline. ■ Oracle Health Sciences Empirica Signal: Detect and analyze safety signals in post-marketing spontaneous adverse reaction data including public health authority databases and/or private inhouse databases such as Oracle Argus. ■ Oracle Health Sciences Empirica Healthcare Analysis: Evaluate safety signals in healthcare data including electronic medical records and administrative claims, and support pharmacoepidemiology, comparative effectiveness analysis, and health economics and outcomes research. For more information on Argus Safety, visit the Oracle Health Sciences Safety suite page at: http://www.oracle.com/goto/pharmacovigilance.html Documentation Accessibility For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc. Access to Oracle Support Oracle customers have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired. Related Documents This section lists the manuals for Oracle Argus products. You can order printed manuals from the Oracle iStore. Oracle Argus Documentation The documentation set includes: ■ Argus Safety Affiliate User Guide ix ■ Argus Safety Administrator’s User Guide ■ Argus Safety Dossier User Guide ■ Argus Safety Interchange User Guide ■ Argus Safety Installation Guide ■ Argus Safety Service Administrator Guide ■ Argus Safety Flexible Aggregate Reporting Extensibility Guide ■ Argus Safety BIP Aggregate Reporting User's Guide ■ Argus Safety User’s Guide ■ Argus Safety Unblinding User Guide ■ Argus Safety Minimum Security Configuration Guide ■ Argus Safety Japanese Administrator’s Guide ■ Argus Interchange Japanese User’s Guide ■ Argus Safety Japanese User’s Guide Conventions The following text conventions are used in this document: Convention Meaning boldface Boldface type indicates graphical user interface elements associated with an action such as Buttons, Dialog boxes, Check boxes, Combo boxes, Drop-down lists, Labels, Option (Radio) buttons, Tabs, Text boxes, etc. "between quotation Information that may appear as-is on screen, or information provided marks" by the user. Note Information that should be noted before proceeding with the instructions. Important Important information that must be noted to ensure accurate, reliable, or safe behavior of the system. Tip Information that enables easier completion of the current task or helps in completing other tasks. Bold Underline Link indicating that additional "pop-down" information is available. ALL CAPITALS Keyboard keys Initial Capitals Names of user interface elements, modules, applications, proper nouns, etc. x