Oracle® Argus Safety Japan User’s Guide Release 8.1.1 E82046-01 September 2017 Oracle Argus Safety Japan User's Guide, Release 8.1.1 E82046-01 Copyright © 2017 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, then the following notice is applicable: U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and adaptation of the programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to the programs. 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 that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software or hardware in dangerous applications. Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners. Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark 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 expressly disclaim all warranties of any kind with respect to third-party content, products, and services unless otherwise set forth in an applicable agreement between you and Oracle. 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, except as set forth in an applicable agreement between you and Oracle. Contents Preface................................................................................................................................................................ vii Where to Find More Information............................................................................................................. vii Documentation Accessibility.................................................................................................................... vii 1 Case Form 1.1 Reporter Information.................................................................................................................. 1-1 1.2 Products Tab................................................................................................................................ 1-2 1.3 Analysis Tab................................................................................................................................ 1-7 1.3.1 PMDA Information tab....................................................................................................... 1-9 1.3.1.1 PMDA Information: General Tab............................................................................... 1-9 1.3.1.1.1 Functionality Changes....................................................................................... 1-11 1.3.1.2 PMDA Information: Comments Tab...................................................................... 1-19 1.3.1.2.1 Functionality Changes....................................................................................... 1-22 1.3.2 Product License Value...................................................................................................... 1-23 1.3.3 PMDA Event Reportability Updates............................................................................. 1-23 1.3.4 Case Form - PMDA Analysis tab.................................................................................... 1-25 1.3.5 PMDA E2B Report Mapping Updates........................................................................... 1-26 1.4 Activities Tab............................................................................................................................ 1-27 1.5 Additional Information Tab................................................................................................... 1-28 1.6 Regulatory Reports Tab.......................................................................................................... 1-30 1.7 Conformance Rules Tab.......................................................................................................... 1-32 2 Case Actions 2.1 PMDA Event Reportability........................................................................................................ 2-1 3 Worklist 3.1 Literature Intake Updates.......................................................................................................... 3-1 3.1.1 Import Tab Changes............................................................................................................ 3-1 3.1.2 Processing Tab Changes..................................................................................................... 3-4 3.1.3 Changes to Literature Duplicate Check............................................................................ 3-5 3.1.4 Changes to Existing Screen Label...................................................................................... 3-6 4 Reports 4.1 Reports: PMDA Expedited Reports......................................................................................... 4-1 iii 4.1.1 Report Scheduling............................................................................................................... 4-1 4.1.2 Paper Reports....................................................................................................................... 4-1 4.1.2.1 Additional Expedited Report Updates...................................................................... 4-3 4.1.2.2 Printed Paper Reports—Formatting Details............................................................. 4-8 4.1.3 User Interface - Reporting Rules Configuration............................................................. 4-9 4.1.4 Expedited Reports on DLP................................................................................................. 4-9 4.1.5 PMDA Device Reports..................................................................................................... 4-11 4.2 Reports: PMDA Periodic Reports.......................................................................................... 4-14 4.2.1 DLP at Report Level......................................................................................................... 4-15 4.2.2 Periodic Reports on DLP................................................................................................. 4-18 4.2.3 Upgrade Considerations.................................................................................................. 4-19 4.2.4 Advanced Conditions in J Periodic Reports................................................................. 4-19 4.2.5 Check in/Checkout Enhancements............................................................................... 4-31 4.2.6 Other Changes................................................................................................................... 4-31 4.2.7 Periodic Safety Report...................................................................................................... 4-31 4.2.7.1 Format......................................................................................................................... 4-31 4.2.7.2 PSR /ReSD Details.................................................................................................... 4-33 4.2.7.2.1 Subject of Report................................................................................................. 4-33 4.2.7.2.2 Product Selection................................................................................................ 4-34 4.2.7.2.3 Periodic Safety Report/ReSD........................................................................... 4-37 4.2.7.2.4 Scheduling........................................................................................................... 4-42 4.2.7.2.5 Security................................................................................................................ 4-44 4.2.7.2.6 Printing PSR / ReSD.......................................................................................... 4-44 4.2.7.2.7 Deleting PSR / ReSD......................................................................................... 4-48 4.2.8 Clinical Study Periodic Safety Report (now J-DSUR)................................................. 4-48 4.2.8.1 Format......................................................................................................................... 4-49 4.2.8.2 J-DSUR Details........................................................................................................... 4-51 4.2.8.2.1 Subject of Report................................................................................................. 4-51 4.2.8.2.2 Product Selection................................................................................................ 4-52 4.2.8.2.3 J-DSUR................................................................................................................. 4-55 4.2.8.2.4 Scheduling........................................................................................................... 4-58 4.2.8.2.5 Security................................................................................................................ 4-60 4.2.8.2.6 Printing CSPSR................................................................................................... 4-61 4.2.8.2.7 Deleting A J-DSUR ............................................................................................ 4-64 4.2.8.3 J-DSUR - Cover.......................................................................................................... 4-64 4.2.8.4 J-DSUR - Form 2......................................................................................................... 4-70 4.2.8.4.1 Domestic Serious AE, etc. Case Occurence Status Line Listing .................. 4-71 4.2.9 Seiyakukyo Line Listing Report (Individual Report Common Line List)................ 4-72 4.2.9.1 Configuration Screen................................................................................................ 4-73 4.2.9.2 Report Output Format.............................................................................................. 4-81 4.2.9.3 Report Output Filter Criterion................................................................................. 4-82 4.2.9.4 Report Output Field Mappings............................................................................... 4-84 4.2.9.5 CSV Output Format.................................................................................................. 4-91 4.2.9.6 Periodic Report Process Flow.................................................................................. 4-91 4.3 Non-Reportable and Invalid Events...................................................................................... 4-93 iv 5 Utilities 5.1 MedDRA Browser....................................................................................................................... 5-1 v vi Preface This document describes the steps for using the components of the Oracle Argus Safety Japan application. Where to Find More Information Oracle Help Center The latest user documentation for Oracle Health Sciences products is available at http://docs.oracle.com/en/industries/health-sciences/. My Oracle Support The latest release notes, patches and white papers are on My Oracle Support (MOS) at https://support.oracle.com. For help with using MOS, see https://docs.oracle.com/cd/E74665_01/MOSHP/toc.htm. 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 that have purchased support 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. vii Reporter Information Case Form 1 This chapter lists the changes that have been introduced in Case Form. 1.1 Reporter Information ■ The Institution ID textbox in Case Form > Reporter Information section is available for both English as well as Japanese users. Figure 1–1 Case Form Report Information section - Sample Output ■ The following are the attributes for this field: – Field Name (Unique Field Label): Reporter Institution ID – Field Form Label: Institution ID – Field Form Label (J) – Help Text: Enter the Institution ID for the Reporter. – Help Text (J) – Hidden radio option set to No. Hiding is allowed. – Read Only options are unchecked and disabled. – E2B Field and Research Field are unchecked by default. – Japanese IME Toolbar is disabled for this field in Case Form even for Japanese user. – Case Form Field Length: 15 AN. No validation required for alphanumeric data check. ■ Both English and Japanese fields point to a common value. ■ This field value is populated based on the Institution ID selected for the Reporter from the Report Information Lookup dialog from the Book-in screen. ■ This field also allows manually entered / updated value directly in the Case Form irrespective of the value specified in the Institution field for the reporter. Manually entered Institution and institution ID field values are allowed in the Reporter Information section even if they are not specified / linked to each other as per Console Institution code list. ■ As both the Institution or Institution ID fields can be present in Reporter Information, and if the user opens up Reporter Lookup for this reporter, then Case Form 1-1 Products Tab Reporter Lookup searches for reporters in Case or Console data based on the following logic: – Out of Institution and Institution ID fields first use Institution ID field with the rest of the search criteria fields. The Institution value is not used in this scenario on the Reporter Lookup search dialog. – If the Institution ID field is not specified in the Reporter Information or if it does not exist in the type-ahead values for this field on Reporter Lookup, then automatically remove the Institution ID field value in Reporter Lookup and search based on Institution field with rest of the search criteria fields. – If Institution field value also does not exist in the type-ahead values for this field on the Reporter Lookup, then remove the Institution field value as well in the Reporter Lookup and search based on rest of the search criteria fields. – If "Search all the reporters who belong to the institution found from the current search item" search option is also used, then it performs a search based on Institution ID or Institution Name - whichever is available on the Reporter Lookup dialog to identify the first set of reporters and subsequently use those reporters for second level search. ■ This field is printed in Case Form Print for Reporter Information section as displayed for both English and Japanese users. Figure 1–2 Case Form Report Information Print - Sample Output ■ This field is audit-logged. ■ This field is available under the following modules: – Case Listing Report – CIOMS II Line Listing Report – CDA Report – Advanced Conditions – Case Form Letter Placeholders as specified below: [reporter_inst_id:primary] [reporter_inst_id]:[n] [reporter_inst_id:selected] [reporter_inst_id:corresp_contact] – Console Field Labels: Under ARGUS SAFETY > GENERAL > Reporter – Console Field Validations: Under ARGUS SAFETY > GENERAL > Reporter 1.2 Products Tab ■ The PMDA Device Information section below Device Information section on Case Form > Products tab > Device sub tab contains fields as specified in the screen mockup displayed below: Case Form 1-2 Products Tab Figure 1–3 Case Form - PMDA Device Information section ■ This case form section is available to all Oracle Argus Safety Japan (Argus J) users on both English as well as Japanese views as uncollapsed by default only when Japanese module is enabled. ■ It is displayed with Japanese labels on both English as well as Japanese views as this section is not meant for translation of data. ■ The Modify, View and No Access rights to this section are based on the "Product Information (Device View)" option in Console > Access Management > Groups > Case Form section. ■ Tabbing order of case form elements respects this section in the order of UI elements as left to right and top to bottom. ■ The "PMDA Device Information" checkbox in Case Print - section selection dialog only to the Argus J user. – This checkbox is added right after "MedWatch Device Information" option in the Case Print options dialog. All the options after it are shifted further by one place. – This checkbox gets selected and unselected when user uses "Select All" and "Unselect All" options. – This checkbox remains unchecked by default and is disabled unless its parent section checkbox "Product Device Information" is checked by the user. If "Product Device Information" is unchecked later, then "PMDA Device Information" also gets unchecked and disabled. Case Form Print PDF report prints this section in Japanese after "MedWatch Device Information" section if it is selected for printing in the section selection dialog. Case Form 1-3