Oracle Argus Safety

Oracle Argus SafetyUser's GuideRelease 6.0.1E15952-03July 2011

Oracle Argus Safety User's Guide, Release 6.0.1E15952-03Copyright 2009, 2011 Oracle and/or its affiliates. All rights reserved.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 iton behalf of the U.S. Government, the following notice is applicable:U.S. GOVERNMENT RIGHTS Programs, software, databases, and related documentation and technical datadelivered 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. Assuch, the use, duplication, disclosure, modification, and adaptation shall be subject to the restrictions andlicense terms set forth in the applicable Government contract, and, to the extent applicable by the terms ofthe Government contract, the additional rights set forth in FAR 52.227-19, Commercial Computer SoftwareLicense (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 notdeveloped or intended for use in any inherently dangerous applications, including applications which maycreate a risk of personal injury. If you use this software in dangerous applications, then you shall beresponsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure the safe useof this software. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use ofthis software in dangerous applications.Oracle is a registered trademark of Oracle Corporation and/or its affiliates. Other names may be trademarksof their respective owners.This software and documentation may provide access to or information on content, products, and servicesfrom third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim allwarranties of any kind with respect to third-party content, products, and services. Oracle Corporation andits affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use ofthird-party content, products, or services.

ContentsPreface . xiii1 Product OverviewApplication Map. 1-12 Getting StartedLogging In and Out. 2-1Logging into the Argus Application . 2-1About the Argus Home Page. 2-3Additional Tabs . 2-4Quick Launch Toolbar. 2-4Error Messages . 2-6Searching for a Case. 2-6Sharing a Case Series . 2-8Basic Features and User Actions . 2-8Sorting on Columns . 2-9Getting Help . 2-10Changing Your Password. 2-11Entering Dates . 2-12Entering Multiple Language Text. 2-13Languages Supported in Argus Safety . 2-133 Active CasesOpening Active Cases . 3-14 Case FormCase Form Functions.Case Form Features.Using Password Acceptance Dialog Boxes .Initial Case Entry.Argus Safety Case Form User Preferences .General Tab .General Usage Information .Dynamic Workflow Indicators.4-14-24-24-34-64-64-74-8v

General Tab: General Information Section. 4-8General Tab: Study Information Section . 4-10General Tab: Reporter Information . 4-11General Tab: Literature Information Section . 4-15Patient Tab . 4-16Patient Tab: Patient Information. 4-16Patient Details Section . 4-18Event Death Details . 4-20Other Relevant History Section . 4-21Lab Data Section. 4-23Patient Tab: Parent Information. 4-25Products Tab . 4-27General Usage Information . 4-28Products Tab: Drug Tab . 4-29Products Tab: Device Tab . 4-35Products Tab: Vaccine Tab. 4-46Product Information Section . 4-46Product Indication Section. 4-51Product Details Section. 4-52Vaccine Information Section. 4-52Vaccine History Section . 4-55Events Tab. 4-56General Usage Information . 4-56Events Tab: Event Tab . 4-59Event Coding Section . 4-63Seriousness Criteria Section . 4-63Events Tab: Event Assessment Tab . 4-66Events Tab: Product -- Event Details Tab. 4-67Analysis Tab . 4-69Case Analysis Section . 4-70Using Auto Narrative Templates . 4-71Case Summary Section. 4-72Analysis Tab: MedWatch Info Tab. 4-73Analysis Tab: BfArM Info Tab . 4-75Analysis Tab: AFSSaPS Info Tab . 4-75Activities Tab . 4-77Activities Tab: Contact Log Section. 4-77Activities Tab: Action Items Section. 4-81Activities Tab: Routing Comments Section . 4-82Activities Tab: Case Lock/Close Section. 4-83Additional Information Tab. 4-86Additional Info Tab Fields and Field Descriptions. 4-87Searching for Documentum Links. 4-88Attaching Files to a Case. 4-88Entering Keywords . 4-88Attaching References to a Case . 4-88Regulatory Reports Tab. 4-88vi

General Usage Information . 4-89Regulatory Report Tab Fields and Field Descriptions . 4-89Grouping Regulatory Reports. 4-915 Case ActionsWorking with Cases . 5-1Finding and Opening Existing Cases. 5-1General Usage Information . 5-2Case Open Form Fields and Field Descriptions . 5-2Search Results Contents . 5-3Sharing a Case Series . 5-3Processing a Case . 5-4Initial Case Entry Fields and Field Descriptions . 5-4Booking in Cases and Entering Initial Case Information. 5-6Checking for Duplicates. 5-8Understanding Receipt Range Limits . 5-8Closing a Case. 5-9Saving a Case . 5-10Copying a Case. 5-10Using the Medical Review Function . 5-10Common Actions . 5-11Using the Medical Review Tab . 5-12Using Temporal View Tab. 5-15Using the Action Items/Addl Info Tab. 5-18About the Contact Log Section . 5-19About the Action Items Section . 5-21About the Notes and Attachments Section . 5-22Using the Coding Review Function . 5-22General Information . 5-23Product Information . 5-23Event Information . 5-23Death Information. 5-24Patient Information. 5-24Lab Data . 5-25Parent Information. 5-25Case Analysis. 5-26Using the Action Item Tab . 5-26Action Item Fields and Field Descriptions . 5-26Using the Print Function. 5-27Accessing Print Medical Summary Functions . 5-28Printing a Case . 5-28Printing a Case. 5-29Viewing and Printing Letters . 5-30Viewing and Printing Attachments. 5-30Transmitting a Case . 5-30Printing a Medical Summary. 5-31Deleting a Case . 5-32vii

Viewing Case Revisions . 5-326 Advanced ConditionsAdvanced Conditions .About the Advanced Condition Screen .Filtering for Existing Advanced Conditions .Viewing Results from Existing Advanced Conditions.Working with Advanced Conditions .Creating, Viewing or Modifying Advanced Conditions.About the Advanced Condition Set Dialog Box.Additional Informa

This software is developed for general use in a variet y of information management applications. It is not developed or intended for use in any inherently dang erous 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 .