Oracle Argus Safety BI Publisher Periodic Reporting Extensibility Guide Release 8.1.1 PDF
Preview Oracle Argus Safety BI Publisher Periodic Reporting Extensibility Guide Release 8.1.1
Oracle® Argus Safety [1] Flexible Reporting Extensibility Guide Release 8.1.1 E87487-02 September 2017 Oracle Argus Safety Flexible Reporting Extensibility Guide, Release 8.1.1 E87487-02 Copyright © 2016, 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. 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Contents Preface................................................................................................................................................................. vi Audience....................................................................................................................................................... vi Where to Find More Information.............................................................................................................. vi Revision History......................................................................................................................................... vii Documentation Accessibility.................................................................................................................... vii 1 Introduction 2 Overview Flexible Reports - What's in the Box..................................................................................................... 2-1 Output Formats........................................................................................................................................ 2-1 Scheduling................................................................................................................................................. 2-1 Report Templates...................................................................................................................................... 2-1 Database Code Wrapping....................................................................................................................... 2-1 3 Flexible Aggregate Reporting Framework Generic Architecture................................................................................................................................ 3-1 4 Flexible Aggregate Reporting - Database Database Architecture............................................................................................................................. 4-1 Flexible Aggregate Reporting - Database Objects......................................................................... 4-1 Tables................................................................................................................................................... 4-1 Views.................................................................................................................................................... 4-3 Database Link..................................................................................................................................... 4-4 Java Stored Procedure....................................................................................................................... 4-4 Packages.............................................................................................................................................. 4-4 Database Jobs...................................................................................................................................... 4-7 Argus Application Schema Objects...................................................................................................... 4-8 Tables................................................................................................................................................... 4-8 Packages.............................................................................................................................................. 4-8 Access Grants to BI Publisher Owner.................................................................................................. 4-8 5 Flexible Aggregate Reporting Design Flexible Aggregate Reporting Design Structure................................................................................ 5-1 iii BI Publisher Data Model................................................................................................................... 5-1 BI Publisher Report Layout.............................................................................................................. 5-4 Aggregate Report Data Flow.................................................................................................................. 5-4 Argus Safety UI Entry....................................................................................................................... 5-4 BI Publisher Data Flow...................................................................................................................... 5-5 6 Extending a Flexible Aggregate Report Database Layer.......................................................................................................................................... 6-1 Configuration Extensibility.............................................................................................................. 6-2 Extending with User Exits................................................................................................................ 6-2 Extending Global Temporary Tables.............................................................................................. 6-4 Extending using Custom Objects..................................................................................................... 6-4 Adding or Modifying a View........................................................................................................... 6-5 Adding a Column to the Existing Table......................................................................................... 6-5 Extending the BI Publisher Data Model.............................................................................................. 6-5 Data Model Query Naming Convention........................................................................................ 6-5 Data Model Nested Queries............................................................................................................. 6-6 Data Structure Groups....................................................................................................................... 6-7 DSUR Summary Table Naming Conventions............................................................................... 6-8 Case Series Tables.............................................................................................................................. 6-9 Lexical Parameters.......................................................................................................................... 6-10 Creating a Custom Report................................................................................................................... 6-12 Blinding Functionality......................................................................................................................... 6-15 Flexible Data Re-categorization.......................................................................................................... 6-16 7 PMDA E2B (R3) Paper Forms - Framework Generic Architecture - PMDA (R3) Paper Reports............................................................................ 7-1 8 PMDA (R3) Paper Report - Database PMDA E2B (R3) Paper Report - DB Architecture.............................................................................. 8-1 DB Objects........................................................................................................................................... 8-1 Tables................................................................................................................................................... 8-1 Java Objects......................................................................................................................................... 8-2 Packages.............................................................................................................................................. 8-2 Argus Application Schema............................................................................................................... 8-3 ACCESS GRANTS to BI Publisher Owner..................................................................................... 8-3 9 PMDA (R3) Paper Report Design BI Publisher Periodic Reports Design Structure................................................................................ 9-1 PMDA (R3) Data Model.......................................................................................................................... 9-1 Data Set............................................................................................................................................... 9-1 Event Triggers..................................................................................................................................... 9-2 Parameters........................................................................................................................................... 9-2 PMDA (R3) Paper Report templates..................................................................................................... 9-4 Argus Safety UI Entry....................................................................................................................... 9-4 iv 10 Extending PMDA (R3) Report Database Layer....................................................................................................................................... 10-1 Extending the BI Publisher Data Model........................................................................................... 10-2 Extending through E2B PMDA Profile............................................................................................. 10-3 Configuring Blinding for PMDA (R3).............................................................................................. 10-5 10.4 Configuring Blinding for PMDA (R3).................................................................................. 10-5 A Troubleshooting BIP Icon not Displayed Against Corresponding BIP Specific Fields in the Periodic Reporting Configuration........................................................................................................................................... A-1 BI Publisher Periodic report does not Execute from Argus UI....................................................... A-2 Database Connection Errors.................................................................................................................. A-3 BI Publisher Scheduled Report Output does not Show up............................................................ A-3 ORA-01427: single-row sub-query returns more than one rowORA-06512: at "<bip_ owner>.PKG_AGG_RPT" for p_updclinicaldrugrole procedure.................................................. A-3 Troubleshooting PMDA (R3) Paper Forms........................................................................................ A-4 Troubleshooting Flexible Aggregate Reports.................................................................................... A-5 v Preface BI Publisher Periodic Reporting enables flexible handling of periodic reports in Argus Safety. The Oracle Argus Safety Flexible Aggregate Reporting (Oracle Argus FAR) Guide provides Argus Safety–BI Publisher integration details, and out-of-the-box periodic report details along with data models, algorithms, and methods to customize or extend these reports as needed. Audience This guide assumes that your organization has the expertise to perform the job functions listed in this section. If your staff lacks these skills, we recommend that you engage Oracle Health Sciences Consulting. Oracle Database Administrators Customizing the database package supplied with Oracle Argus FAR requires a level of knowledge equivalent to having mastered the material in Oracle's DBA Architecture and Administration course. You must be able to read SQL*Plus scripts and edit them. You must be able to run SQL scripts and review logs for Oracle errors. System Administrators Customizing and maintaining an Oracle Argus Safety BI Periodic Reporting requires mastery of the following tools: ■ Microsoft Windows Operating System ■ Unix or Linux based Operating Systems ■ OBIEE and (or) Oracle BI Publisher ■ Oracle Web Logic Administration 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. vi Revision History September 2017: Updated format for OHC. No content change. 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 1 Introduction 1 Argus Safety Flexible Reporting leverages the capabilities of the Oracle BI Publisher reporting solution for Argus Safety Reports. This solution helps customers overcome the challenges of periodic reporting to meet a variety of business needs. This document provides Argus Safety–BI Publisher integration details, describes the BI Publisher Periodic Reports framework, and describes ways to customize the report as per customer needs. This document also talks about the PMDA (R3) Paper Reports Framework using BI Publisher. Introduction 1-1 Oracle® Argus Safety Flexible Reporting Extensibility Guide 2 Overview 2 This chapter provides an overview of the product. 2.1 Flexible Reports - What's in the Box Periodic Reports ■ Periodic Benefit Risk Assessment Report (PBRER) ■ Development Safety Update Report (DSUR) ■ The Post Marketed Aggregate Report (PMAR, also called PSUR) Expedited Reports ■ PMDA R3 Paper Forms 1-6 2.2 Output Formats Out-of-the-box Argus Safety BI Publisher reports support the following output formats by default: ■ PDF ■ RTF You can also get the output in an XML format. The out-of-the-box reports are not designed to support the CSV format. However, you can prepare a custom report supporting the CSV format. 2.3 Scheduling Oracle Argus Flexible Reporting Framework supports Quartz scheduler. 2.4 Report Templates Out-of-the-box (OOTB) Argus Flexible reports use RTF templates. 2.5 Database Code Wrapping All Argus Safety objects are code wrapped. However, to facilitate and encourage customers to handle their own customizations, the system does not wrap database code under the (BIP Owner User). Overview 2-1
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