Administration Guide Oracle Argus Safety
Oracle Argus SafetyAdministration GuideRelease 8.2.2F34215-01October 2020
Oracle Argus Safety Administration Guide, Release 8.2.2F34215-01Copyright 2009, 2020, Oracle and/or its affiliates.This software and related documentation are provided under a license agreement containing restrictions onuse and disclosure and are protected by intellectual property laws. Except as expressly permitted in yourlicense 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. Reverseengineering, disassembly, or decompilation of this software, unless required by law for interoperability, isprohibited.The information contained herein is subject to change without notice and is not warranted to be error-free. Ifyou 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 onbehalf of the U.S. Government, then the following notice is applicable:U.S. GOVERNMENT END USERS: Oracle programs (including any operating system, integrated software,any programs embedded, installed or activated on delivered hardware, and modifications of such programs)and Oracle computer documentation or other Oracle data delivered to or accessed by U.S. Governmentend users are "commercial computer software" or "commercial computer software documentation" pursuantto the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such,the use, reproduction, duplication, release, display, disclosure, modification, preparation of derivative works,and/or adaptation of i) Oracle programs (including any operating system, integrated software, any programsembedded, installed or activated on delivered hardware, and modifications of such programs), ii) Oraclecomputer documentation and/or iii) other Oracle data, is subject to the rights and limitations specified in thelicense contained in the applicable contract. The terms governing the U.S. Government’s use of Oracle cloudservices are defined by the applicable contract for such services. No other rights are granted to the U.S.Government.This software or hardware 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 thatmay create a risk of personal injury. If you use this software or hardware in dangerous applications, then youshall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure itssafe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of thissoftware or hardware in dangerous applications.Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks oftheir respective owners.Intel and Intel Inside are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks areused under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Epyc,and the AMD logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registeredtrademark of The Open Group.This software or hardware and documentation may provide access to or information about content, products,and services from third parties. Oracle Corporation and its affiliates are not responsible for and expresslydisclaim all warranties of any kind with respect to third-party content, products, and services unless otherwiseset forth in an applicable agreement between you and Oracle. Oracle Corporation and its affiliates will notbe responsible for any loss, costs, or damages incurred due to your access to or use of third-party content,products, or services, except as set forth in an applicable agreement between you and Oracle.
ContentsPreface12Documentation accessibilityixRelated resourcesixAccess to Oracle SupportixIntroductionOracle Argus Safety Configuration Process Overview1-1Usage Conventions1-2Getting Started1-2Argus Console Architecture1-3Required Fields1-4Standard Buttons1-4Standard Icons1-4Administrator Login1-6Logging In as an Administrator1-6Changing the Administrator's Password1-8Logging out1-8Accessing the Home Page1-9Launching Online Help1-9View the Error Log1-9Understanding Argus Console GUI1-9Access ManagementConfiguring User Sites2-1Field Descriptions2-1Adding User Sites2-2Configuring Groups2-5Field Descriptions2-6Adding User Groups2-7Printing a User Group2-12About Filtering Criterion2-13iii
Configuring UsersField Descriptions2-15Printing Users2-17User Configuration - Roles32-17Business ConfigurationEditable and Non-editable Business Configuration Sections3-1Type Ahead Fields3-3Additional Comments Fields3-3Configuring Product Family3-4Field Descriptions3-4Adding Product Families3-5Creating Data Sheets3-7Field Descriptions3-7Configuring Products3-11Field Descriptions3-12Adding Products3-13Configuring Licenses3-15Field Descriptions3-16Adding Product Licenses3-19Using the Product Browser3-21Configuring Clinical Studies3-22Field Descriptions3-25Adding Clinical Study Configurations3-30Adding WHO Drug Details3-32Adding Product Details3-33Configuring Auto Encoding3-35Configuring Study Reporting3-37Configuring Expedited Report Rules3-38Field Descriptions3-41Expedited Reporting Rules Algorithm3-45Adding Expedited Report Rules3-46Configure Regulatory Reporting Rules42-143-50Work with the DictionariesMedDRA Dictionary4-1Prerequisites4-1Load MedDRA or MedDRA J Dictionary4-2Overwrite an Existing MedDRA or MedDRA J Dictionary4-2iv
Recode MedDRA54-3Logic to Recode MedDRA4-4Run the Dictionary Management Tool to Recode Events4-6Recode MedDRA terms at the Enterprise level4-7WHO Drug Dictionary4-7Prerequisites4-8Load WHO Drug Dictionary to New Tables4-8Overwrite an Existing WHO Drug Dictionary4-9Load WHO Drug Dictionary Format C4-9J Drug Dictionary4-10Prerequisites4-10Create and Modify Required File4-11Create All Data.txt file4-11Create formulationcode.txt file4-12Create drugnameenglish.txt file4-13Modify the.mdb file4-13Load J Drug Dictionary4-14Overwrite an Existing J Drug Dictionary4-14System ConfigurationConfiguring Case Priority5-2Field Descriptions5-2Configuring Field Validations5-4Field Descriptions5-5Modifying Field Validations5-6Configuring LAM System NumberingField DescriptionsConfiguring System Management - Common Profile Switches5-75-75-9Configuring Advanced Conditions5-12Configuring Background Services5-13Configuring Case Form (System Management)5-14SMTP Configuration5-22Configuring Case Processing5-23Configuring Database5-28Configuring Assessments5-29Configuring Auto Archiving5-31Configuring Case Numbering5-32Configuring Lot Number5-33Configuring the Dictionary Browser5-34Configuring Group Data Access5-36v
Configuring WHO Drug5-36Configuring Performance5-36Configuring Documentum5-37Local Labeling5-42Network Settings5-44User Interface5-46Configuring Reporting5-46Configuring Security5-63Configuring Single Sign-On5-66Error Messages5-69Configuring SMTP5-69Configuring Workflow Items5-70Configuring Workflow5-73Worklist Updates5-73Configuring Case Workflow5-74Worklist Intake5-78Configuring System NumberingField DescriptionsConfiguring Field PropertiesField Descriptions65-855-865-885-89Adding User Defined Fields5-90Configuring User Defined Fields5-91Configuring Local Data Entry5-92About Local Fields5-92Access Local Case Data Lock Functionality5-94Process an Outlier5-96Activate Local Locking in Oracle Argus Safety5-96Activate Local Reporting in Oracle Argus Safety5-97Enabled Modules5-98Interchange Mapping5-99Code List ConfigurationConfiguring Code Lists Argus6-1Configuring Autosignals6-2Field Descriptions6-2Configuring Batch Reports6-4Field Descriptions6-4Configuring Letters6-5Field Descriptions6-6Configuring Justifications6-8vi
Field DescriptionsConfiguring Electronic Transmission6-11Configuring Event Groups6-12Terms tab6-13Event Groups tab6-15SMQ tab6-156-17Field Descriptions6-18Configuring Message Type6-19Field Descriptions6-20Configuring Reporting Destination6-21Agency Information6-22Local Company Contact6-26Configuring EDI6-28Configuring the Base Directory Path6-33SMTP6-34Configuring Routes of Administration6-35Field Descriptions6-36Configuring Study Center6-37Field Descriptions6-38Configuring Holiday Calendar6-39Field Descriptions6-40Other Code List Items6-40Configuring Code Lists Flexible Data Re-Categorization86-10Field DescriptionsConfiguring Literary Citations76-96-46Flexible Code Lists6-47Flexible Re-Categorization6-48Add custom values to a flexible code list6-54Accessing ToolsReport Features7-1Viewing the ICSR Length Check Report7-2Using Advanced ConditionsFeatures within Advanced Conditions8-2Using Advanced Conditions8-3Creating Advanced Conditions8-3Creating a Query Set of Advanced Conditions8-6New Action Type Fields and Field Description8-7vii
9Rename Query Sets8-9Use the Advanced Conditions from the Case Selection Dialog Box8-9Use the Advanced Conditions Library8-10Case Series (former Hit List) Tab8-10Data PrivacyPersonally Identifiable Information9-1Personally Identifiable Information and Application Behavior9-4viii
PrefaceThis preface contains the following sections: Documentation accessibility Related resources Access to Oracle SupportDocumentation accessibilityFor information about Oracle's commitment to accessibility, visit theOracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx acc&id docacc.Related resourcesFor information about Oracle Argus patches, see My Oracle Support.All documentation and other supporting materials are available on the Oracle HelpCenter.Access to Oracle SupportTo receive support assistance, determine whether your organization is a cloud oron-premises customer. If you're not sure, use Support Cloud.Cloud customers receive support assistance through Support CloudOracle customers that have purchased support have access to electronic supportthrough Support Cloud.Contact our Oracle Customer Support Services team by logging requests in one of thefollowing locations: English interface of Oracle Health Sciences Customer Support Portal (https://hsgbu.custhelp.com/) Japanese interface of Oracle Health Sciences Customer Support Portal (https://hsgbu-jp.custhelp.com/)You can also call our 24x7 help desk. For information, visit iences-cloud-support/index.html or visithttp://www.oracle.com/pls/topic/lookup?ctx acc&id trs if you are hearing impaired.ix
PrefaceOn-premises customers receive support assistance through My Oracle SupportOracle customers that have purchased support have access to electronic supportthrough 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 trsif you are hearing impaired.x
1IntroductionOracle Argus Safety assists manufacturers of pharmaceuticals and devices byproviding a simple and efficient way to comply with international and domesticregulatory safety reporting requirements. It also facilitates internal company safetysurveillance by providing tools for signal detection and for analyzing the overall safetyprofile of both investigational compounds and marketed products.Note:An * has been placed before fields that have been introduced in a previousrelease but are currently non-operational.For more information, see: Oracle Argus Safety Configuration Process Overview Usage Conventions Getting Started Argus Console Architecture Administrator LoginOracle Argus Safety Configuration Process OverviewTo configure Oracle Argus Safety, the Administrator must follow a particular sequenceof steps. Steps that fall later in the sequence might depend on those that appearearlier. It is, therefore, important for the Administrator to use the following flowchart asa guideline for configuring Oracle Argus Safety.1-1
Chapter 1Usage ConventionsTaskPurposeConfigure User Sites, Groupsand AccountsEnter user sites, create user groups and user accounts,configure group and individual user access rights.Configure ProductsConfigure Manufacturers, Ingredients, Formulations, DosageUnits, Product Families, and Data Sheets.Configure LicensesEnter license information, countries and products associatedwith the license.Configure Code List ItemsConfigure list maintenance items that are not covered in othertopics, like Action Taken, Clinical Studies, Study Centers, etc.Configure WorkflowConfigure case workflow states and rules that determine thetransition of cases between states.Configure RegulatoryReportingConfigure Regulatory Agency information and expeditedreporting rules.Configure System OptionsConfigure miscellaneous system items like Auto-numbering,Field Labels, etc.Configure Case FormConfigure Case Form dictionaries, duration calculations, etc.Configure LettersCreate letter templates by using template placeholders.Configure Database Common Configure the Common Profiles Table to customize the OracleProfilesArgus Safety application.Usage ConventionsThe following conventions are used throughout this document to help you identifyspecific kinds of information.Usage ConventionDescriptionBoldUser interface elements such as Buttons, Dialog boxes, Check boxes,Combo boxes, Drop-down lists, Labels, Option (Radio) buttons, Tabs,Text boxes, etc."between quotationmarks"Information that may appear as-is on screen, or information providedby the user.Note: TextInformation that should be noted before proceeding with theinstructions.Important! TextImportant information that must be noted to ensure accurate, reliable,or safe behavior of the system.Tip: TextInformation that enables easier completion of the current task or helpsin completing other tasks.ALL CAPITALSKeyboard keysInitial CapitalsNames of user interface elements, modules, applications, propernouns, etc.Getting StartedThis section introduces the basic tasks for configuring Oracle Argus Safety. To getstarted with the configuration process, the person responsible for configuring OracleArgus Safety must log on as Administrator to configure the Argus Console.1-2
Chapter 1Argus Console ArchitectureRefer to the following sections for information pertaining to:SectionTopics CoveredAdministrator Login Logging in and out of the Argus ConsoleChanging the Administrator passwordAccessing the Home Page and Online HelpUnderstanding Argus Read this section for an overview of the Argus Console user interfaceConsole user interface components.Argus Console ArchitectureThe Oracle Argus Web Administration Console has been designed to enhance ease ofnavigation for the Oracle Argus Safety end-users.The following illustration shows the design and location of the individual componentsunder the main Argus Console Menu.Note:The menu items that you can access depend on the security permissionsthat are defined for your account by the administrator.For more information, see:1-3
Chapter 1Argus Console Architecture Required Fields Standard Buttons Standard IconsRequired FieldsFields that are marked with a red flag image and associated with an orange boundaryare required fields. These fields must be filled in, to proceed with the configurationrequirements.Standard ButtonsThe standard buttons used in this console are described in the following table:ButtonDescriptionSaveUse this button to save changes associated with a section.CancelUse this button to cancel changes associated with a section.PrintUse this button to print information associated with a sub-section in aPDF.DeleteUse this button to delete an item associated with a section.CopyUse this button to create a new editable copy of an item within asection.OKUse this button to confirm an action associated with a section.YesUse this button to confirm an action associated with a section.NoUse this button to cancel an action associated with a section.HelpUse this button to launch the online manual for the Argus Console.Add NewUse this button to add a new item associated with a section.Standard IconsThe standard icons used in this console are described in the following table:IconIdentifiesA required field.An item placed inside a folder in the tree-view.1-4
Chapter 1Argus Console ArchitectureIconIdentifiesA closed folder containing sub-folders or nodes.An open folder displaying sub-folders or nodes.An open folder that does not contain sub-folders or nodes.A closed folder that does not contain sub-folders or nodes.An expandable or collapsible browser tree view.An option to sort columns alphabetically (when placed next to a columnheader).An item appearing under multiple categories (e.g. a user nameappearing under multiple groups).A withdrawn license in the tree-view of licenses.1-5
Chapter 1Administrator LoginAdministrator LoginWhen Argus Safety is installed, an account for the Administrator is automaticallycreated. The installation program assigns admin as both the User Name andPassword for this account.Before logging in to the Argus Console, be aware of the following: If you enter an incorrect username or password three (3) consecutive times, thesystem disables the Login button and displays the following message:The login button has been disabled due to 3 consecutive incorrect entries ofUsername or Password. Please refresh the page to enable the Login button. The Date/Time 24-hour format used by the Web server: DD-MMM-YYYYHH:MM:SS.Note:The Administrator or System password can be reset from new Argus KeyManagement Tool Reset Password for the default Administrator andSystem Account.For more information, see: Logging In as an Administrator Changing the Administrator's Password Logging out Accessing the Home Page Launching Online Help View the Error Log Understanding Argus Console GUILogging In as an Administrator1.Enter the Argus URL in your web browser, to launch Oracle Argus Safety. Thelogin screen appears as shown:1-6
Chapter 1Administrator LoginTip:2. The modules displayed in bold text identify the modules you havepermission to access. Your login user ID and password are valid for all accessible Argusmodules.Enter the User Name and Password to login to Oracle Argus Safety.Note:The password is case-sensitive.3.Select the database name from the Database list.4.Press Enter or click Login.5.When the window opens, click Yes to proceed with the login.1-7
Chapter 1Administrator LoginNote:If the window does not appear, verify that your brower's Pop-Up blockeris disabled.6.Click Argus Console to launch the Argus Console Administrator screen.Note:If the window does not appear, verify that your brower's Pop-Up blockeris disabled.Changing the Administrator's Password1.Select Utilities Change Password in Oracle Argus Safety.2.The Change Password dialog opens.3.Enter the current password and the new password.Note:In case of a Single Sign-On user, the Change Password option is notsupported in Argus Safety.4.Confirm the new password and click OK.1.Click Close to leave the Argus Console application.2.To log out at any time from Oracle Argus Safety, click Logout.Logging out1-8
Chapter 1Administrator LoginAccessing the Home PageTo go back to the Home page, click Home. The default Home page appears.Launching Online HelpTo launch the Online Help, click Help.View the Error LogTo view the error log for information about errors that occurred during case processing:1.From the Utilities drop-down menu, go to Logs View Error Log.2.To search for error logs based on pre-defined or custom date ranges, in theSearch Conditions section, enter a value, and click Search.The search results appears in the Total Number of Rows section.3.Locate the error log you want to view, and click to view the error message text.4.Click the Zoom icon to view the complete text.Understanding Argus Console GUIThis section broadly categorizes the sections of the
Overwrite an Existing WHO Drug Dictionary 4-9 Load WHO Drug Dictionary Format C 4-9 J Drug Dictionary 4-10 Prerequisites 4-10 Create and Modify Required File 4-11 Create All_Data.txt file 4-11 Create formulationcode.txt file 4-12 Create drugnameenglish.txt file 4-13 Modify the.m
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The information in this manual is furnished for informational use only and is subject to change without notice. Although our best efforts were used in preparing this book, Argus Control Systems Limited assumes no responsibility or liability for any errors or inaccuracies that may appear. Trademarks: Argus Controls, Argus Graph, Argus Control Systems, Argus Titan, and the Argus logo are .
Version: 4.05 Doc. Version: 1.2 Rev. Date: 19/8/08 ARGUS Developer Reference Manual ARGUS Software: ARGUS Developer Reference Manual The contents of this document are considered proprietary by ARGUS Software, the information enclosed and any portion thereof may not be utilised for any purpose other than the consideration of ARGUS Software. Information in this document is subject to change .
WHO Drug Dictionary Third Party Software Limitations: Documentum is not supported for Oracle Argus Cloud Service. Use of RightFax with Oracle Argus Cloud Service is partially enabled. For faxing from Oracle Argus Cloud Service, fax via email
ARGUS Valuation - DCF, otherwise ARGUS Valuation - DCF may not run properly. ARGUS Valuation - DCF will be available in a folder in the Start menu and as a shortcut on your Windows desktop. When you launch ARGUS Valuation - DCF for the first time, you will be prompt
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rapidLIVE Argus. Based on the industry leading safety database Oracle Argus , rapidLIVE Argus provides a complete, proven configuration and support across the complete project lifecycle to reduce the arduous task of implementing and maintaining the safety system. The result is a ready-to-use system. While rapidLIVE Argus can be used for an
